The Homicide Files: Celexa & Lexapro

Following on from my last post, The Murderous Pills and The Keystone Cops (FDA), which highlighted 6 cases of Paxil related homicide, I now turn my attention to Celexa, known in Europe by its brand name of Cipramil and better known as its generic name of citalopram. Also included is the sister drug to Celexa, namely, Lexapro, known in Europe by its brand name of Cipralex and better known as its generic name of escitalopram.

Once again I will highlight just 6 cases of prescripticide* ~ there are many more in the Murder Meds database.


AERS Case Number 6301497

Homicide by male (age unknown. The patient was taking Celexa (40mg per day) between October 2003 to an unspecified date.

This was sent to Medwatch from a court clerk who had heard the evidence of the accused at trial. Pay particular attention to the side effects leading up to the murder. (Click on images to enlarge)

http://www.murdermeds.com/index.php/2016/01/30/aers-case-number-6301497/

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AERS Case Number 7574444

Homicide by male (78). The patient was taking Celexa (20mg per day) for just 5 days.

Notice, in the report, how his whole mood changed once he started Celexa therapy.

http://www.murdermeds.com/index.php/2016/01/22/aers-case-number-7574444/

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AERS Case Number 5850018

Homicide by male (54). The patient was taking Lexapro, unknown dosage, over a period of 2 to 4 weeks.


As you will see, the patient had no prior history of violence or aggression.

http://www.murdermeds.com/index.php/2016/01/16/aers-case-number-5850018/

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AERS Case Number 7274376

Homicide by male (37). The patient was taking Lexapro, 10mg, over a short period of time before he shot and killed his girlfriend and critically wounded a young man. He then failed in his own suicide attempt.

http://www.murdermeds.com/index.php/2016/01/21/aers-case-number-7274376/

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AERS Case Number 6044971

Homicide by male, 55, (Initially the report said he was 40 but this was later rectified)  The patient was taking Lexapro, unknown dosage, over an unspecified time before he shot and killed his wife.

Remarkably, his treating physician did not consider that Lexapro played any part in the, seemingly, induced psychosis. Something that truly baffles me given that this is based on an assumption of the doctor and not scientific evidence.

http://www.murdermeds.com/index.php/2016/01/17/aers-case-number-6044971/

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Finally, the last case is familiar as it concerns 22 year old Shane Clancy from Ireland. His name is omitted from this report. After reading it may be worth listening to the podcast (Link after images) 3 pages of the 6 page report have been redacted (for reasons unknown)

Shane was on citalopram for just 17 days.

AERS Case Number 7164838

(Listen to Podcast for full details)

http://www.murdermeds.com/index.php/2016/01/21/aers-case-number-7164838/

The above case is explained in great detail in the following Podcast recorded between myself and Shane's mother, Leonie Fennell, back in 2011.

Bob Fiddaman.

*Prescripticide ~  is defined as a death that is caused by an adverse reaction to a prescription drug.

Previously in this Homicide series...

The Murderous Pills and The Keystone Cops (FDA) - Paxil

Database available on Murder Meds.

This blog post is dedicated to the memory of Shane Clancy.

Court Documents Show Celexa in Bad Light for Kids

The above meme is applicable to doctors and patients alike. The 'open your mouth' line fits perfectly for both. Doctors should know all the facts before they recommend a treatment to a patient, a patient should know all the facts about the said treatment before they open their mouths to ingest it.

Which brings me nicely to a study recently published regarding a clinical trial involving a widely prescribed antidepressant. Citalopram, known better by its brand names of Celexa in the US and Cipramil in the UK.

Citalopram was tested in kids between 1999 and 2002 and was known as CIT-MD-18 pediatric depression trial. The results and subsequent publication of those results were, as we've come to expect, ghostwritten by PR company Weber Shandwick, more specifically it was ghostwritten by Natasha Mitchner at Weber Shandwick Communications, under instruction from Jeffrey Lawrence (Product Manager Forest Marketing)

For those who don't know, Forest Labs are the American pharmaceutical company that market Celexa. Forest Labs are a subsidiary of Forest Pharmaceuticals.

“A randomized, placebo-controlled trial of citalopram for the treatment of major depression in children and adolescents,” was published in the American Journal of Psychiatry in June 2004. However, its lead author wasn't neither Mitchner or Lawrence.

Some 10 years after publication a lawsuit against Forest was, in part, settled. The lawsuit, Celexa and Lexapro Marketing and Sales Practices Litigation, had during its intensive investigation, found the confidential documents relating to CIT-MD-18, 750 of which, have now been made public on the on the Drug Industry Document Archive (DIDA) website. In all, over 63,000 documents were handed over to plaintiff lawyers who were suing Forest Labs for the safety and efficacy of Celexa and Lexapro (US trade names for citalopram and escitalopram respectively) in marketing the drugs “off-label” for pediatric use.

The 750 public documents have been desconstructed by Jon N. Jureidini, Jay D. Amsterdam, and Leemon B. McHenry and the results are startling, to say the least.

"The citalopram CIT-MD-18 pediatric depression trial: Deconstruction of medical ghostwriting, data mischaracterisation and academic malfeasance" shows, amongst other things, that;

CIT-MD-18...

• Contained efficacy and safety data inconsistent with the protocol criteria.
• Procedural deviations went unreported.
• Negative secondary outcomes were not reported.
• Adverse events were misleadingly analysed.
• Manuscript drafts were prepared by company employees and outside ghostwriters with academic researchers solicited as ‘authors’.
• Authors failed to mention that the five citalopram-treated subjects discontinuing treatment did so due to one case of hypomania, two of agitation, and one of akathisia, none of these conditions were found in the placebo group.

The deconstruction of the 750 documents also showed the authors that protocol-specified outcome measures showed no statistically significant difference between citalopram and placebo. In other words, children taking citalopram found it as effective as taking a sugar-coated pill.

This is contrary to the 2004 study published in the American Journal of Psychiatry in June 2004 where it was stated that, "In this population of children and adolescents, treatment with citalopram reduced depressive symptoms to a significantly greater extent than placebo treatment and was well tolerated."

Fig 1

The 2004 study shows that its lead author was Karen Dineen Wagner (Fig 1) but as the deconstruction study shows Wagner merely added her name to the study (as lead author) that was penned by Natasha Mitchner at Weber Shandwick Communications.

Wagner is no stranger to controversy, she'd previously added her name to the Paxil 329 ghostwritten paper without actually looking at the raw data [which showed an increased rate of suicidal thoughts in kids taking Paxil]. It's also been learned through various litigation in the US that Wagner was paid to deliver lectures promoting the use of Paxil for depressed kids and teens to both GSK’s sales reps and doctors, this despite ever taking a look at the raw data of 329. Maybe she had faith in the ghostwriter of Paxil 329, Sally K. Laden, just as she did with the Celexa ghostwriter Natasha Mitchner ~ Who knows what makes Wagner tick?

In the complaint filed against Forest Labs it was alleged that the American pharmaceutical company arranged for Karen Wagner to give promotional presentations on the pediatric use of Celexa and to serve as the chair of a seven-city Continuing Medical Education ("CME") program on treating pediatric depression... even though the CIT-MD-18 trial was a failure.

So, to recap...

• Forest conduct clinical trials then write up the results of that trial via a ghostwriter.
• Once the study result are written, Forest hire well known pediatric psychiatrists to claim the the ghostwritten work is theirs.
• Despite Celexa showing no efficacy over placebo, the study (now allegedly written by Karen D. Wagner) shows that it "reduced depressive symptoms to a significantly greater extent than placebo."
• Forest Labs are denied a licence to sell Celexa for child depression but, none the less, send out reps to promote it's safety to prescribing physicians, who were often "dined and dashed" in efforts to get them to prescribe Celexa, the drug that was shown not to work in kids, to kids.

Oh, I forgot to mention, the kids targeted by Forest, Wagner et al were age 7 to 17.

Jon N. Jureidini, Jay D. Amsterdam, and Leemon B. McHenry conclude their findings with...

"It is important to make these articles transparent to correct the scientific record. It is furthermore imperative to inform the medical community of mischaracterized data that could lead to potential harm to children and adolescents who are vulnerable to the effects of medication on the growing brain and may increase suicidal thinking and behaviour."

I couldn't agree more.

Jureidini, Amsterdam, and McHenry ~ take a bow. I salute you all.

Drs. Amsterdam and Jureidini were engaged by Baum, Hedlund, Aristei & Goldman as experts in the Celexa and Lexapro Marketing and Sales Practices Litigation. 

Dr. McHenry was also engaged as a research consultant in the case. Dr. McHenry is a research consultant for Baum, Hedlund, Aristei & Goldman.

"The citalopram CIT-MD-18 pediatric depression trial: Deconstruction of medical ghostwriting, data mischaracterisation and academic malfeasance" appears in the International Journal of Risk & Safety in Medicine, vol. 28, no. 1, pp. 33-43, 2016

Fiddy Rant.

So, here we see yet another pharmaceutical company hiring the ghost writing services of a PR firm. Yet another pharmaceutical company who make claims that a drug is safe and effective when it isn't. Once again we see prominent psychiatrists adding their names to published papers when their input to these published papers is minimal to say the least. Furthermore, and yet again, we see a pharmaceutical company promote the use of a non-efficacious drug by wining and dining health care professionals.

Citalopram is from a group of medicines known as Selective Serotonin Reuptake Inhibitors (SSRIS). It has been well documented that Citalopram can induce thoughts of suicide and homicide in many numbers of people that take it. Why then, did Forest Labs spin the data on the CIT-MD-18 pediatric depression trial? Why did Karen Wagner et al claim to have written the study when court documents show that it was written by someone else?

Moreover, what is it with pharmaceutical companies and top paediatric psychiatrists and their apparent lack of care for the safety of 7-to 17 year-olds?

Criminal charges need to be brought against those who played a part in the manipulation of this study. That goes for the top executives at Forest Labs, the reps who promoted its use in kids and the top psychiatrists who put their names to support the data (without actually looking at the data). Charges too should be brought against any doctor who received a bribe from Forest Lab reps, be that a free dinner of tickets to the baseball game.

Off-label prescribing of antidepressants to kids is wrong. I know there are some that disagree with me but look at the facts now. Study 329 (Paxil didn't work in kids) - CIT-MD-18 (Celexa didn't work in kids) ~ So, why prescribe something that doesn't work? 

The side effects of Celexa are pretty horrific for adults let alone children ~ don't even get me started on they harm the can cause to fetuses!

The evidence in these two recent cases now show that neither Paxil or Celexa is beneficial to children yet in 2016 both drugs are still prescribed to children. The heavy illegal promotion undertaken by GlaxoSmithKline and Forest Labs reps still works to this day.

Shit doesn't just stink, it sticks.

Over to you, DOJ.

Bob Fiddaman.

Related

The jewel in the crown ~ Mikey Nardo

The Shane Clancy Case: Celexa Induced Homicide/Suicide

Citalopram Birth Defects (Guest Post)

Q&A With Leonie Fennell

Imagine, if you will, a Sunday morning. You have that extra hour in bed with your partner. You can hear the kids downstairs playing, the TV is blaring, their laughter makes you smile.

You climb out of your slumber and head for the kitchen, breakfast is soon on the go and you all sit down as a family to eat.

Imagine, if you will, a knock at your door. On answering you see two police officers.

They are the bearers of bad news ~ they tell you that your son is wanted for questioning, moreover, they tell you that he is suspected of killing someone.

Imagine, if you will, during this visit a message comes through on one of the officer's walkie-talkies. "We've found the suspect, he's at the rear of the property... he's dead."

The unthinkable.

Leonie Fennell and her husband Tony don't need to imagine. This is their reality.

I first met both Tony and Leonie at an award ceremony in East Grinstead. We stayed up until the small hours talking about their son, Shane. It, for me, was heart-wrenching to hear and see two broken parents, particularly as my roots stem from Ireland (my mother being born and raised there)

We kept in touch and I've popped across the Irish sea to see them both on a number of occasions. Words cannot describe this beautiful couple, this beautiful family ~ all plodding along after such a tragedy. I've met Leonie's extended family too, a wonderful bunch (clan) who made me feel so welcome.

Leonie, as you will see from the Q&A's, has been very vocal in her mission to raise awareness about antidepressants. Shane was just 22 when he broke up with his girlfriend. He was heartbroken - he was prescribed the powerful antidepressant, citalopram (known as Celexa in the US). A month or so later Shane committed homicide and then killed himself, two acts brought on by induced psychosis, an adverse side effect of citalopram.

Tony and Leonie have been a part of my 10 year journey with this blog. I love them both dearly.





Full name: Leonie Fennell
Age: 50
Location: Wicklow, Ireland.



Q: Leonie, now that you have established yourself as a blogger, do you feel that your work over the years has brought about change in the way that many feel about antidepressant use?

A: Surprisingly, I do. The feedback suggests that the public are far more enlightened to the harms that come directly from putting harmful chemicals into our bodies. It has taken a long time for people to realise that medicines (prescribed by a friendly GP), while often doing good, can equally cause huge harm. When I started out in 2009, antidepressants were mainly seen as harmless happy-pills. People now seem far more cautious and whether they believe me or not, is irrelevant. Being aware of issues can often mean an adverse reaction is recognised for what it is - caused by the drug and not the supposed ‘illness’.  I think, in Ireland at least, largely due to the work of Irish doctor David Healy, people are questioning over-medicalization, particularly of our children. The tide is definitely turning on the pharmaceutical industry.


Q: They say that behind every good woman is a good man (or something like that). Your other half, Tony, has, I know, been a tower of strength for you and your family. How important is it, for you, to have the support of Tony?


A: He’s amazing - my rock. Don’t tell him I told you though, wouldn’t want him to get a big head. Joking aside, Tony has kept us all going, through thick and thin, through the laughter and the tears. He’s like a big soft cuddly toy - a bit battered and bruised, but totally-loved teddy bear. He was a broken man when Shane died and while the scar tissue must surely be visible under a microscope, he’s survived to battle on, especially for Shane. As a family we still laugh often - sometimes at Tony, but usually with him. I think he quite likes it.

Q: Back in 2011 you and Tony travelled to Denmark to meet with Lundbeck. The subject matter, in the main, was about citalopram (Celexa), the antidepressant that induced psychosis is your son, Shane. Can you tell me more about that meeting and how you feel it went?

A: To be honest, it wasn’t too surprising. I think the Lundbeck officials we met actually expected us to accept their denials and walk away hand-in-hand into the Copenhagen sunset. Instead, they just confirmed what we knew already, that most pharmaceutical companies will lie and cheat in order to cover up the harms done by their chemicals. The many deaths, like Shane’s, are brushed aside as collateral damage, a nuisance. The meeting was a bizarre experience.

Q: On average, how much time do you spend with work that relates to your blog?

A: Many, many, hours. I could often spend entire days doing research, which may or may not turn out to be useful. It’s my form of relaxation and I could quite happily sit in the midst of chaos while working on a particular subject.

Q: 2011 was, it appears, a busy year for you. In the summer of that year you were contacted by solicitors with regard to something you wrote about Irish psychiatrist, Patricia Casey. Can you tell me what all that was about and what was the outcome?

A: Casey is probably one of Ireland’s most widely recognised psychiatrists. She often sends people solicitor’s letters when she gets offended – which is quite frequent. I have never been reticent about being shocked and distressed when she commandeered Shane’s inquest, arriving uninvited to offer her assistance to the coroner. After her offer was ignored, she then wasn’t happy with the jury’s decision (an ‘open’ verdict). Directly after the inquest, on the steps coroner’s court, she proceeded to speak to the waiting media, stating there were aspects of the evidence that the college (of psychiatry) took issue with. I think her issues were with Dr David Healy, who testified that these drugs can be dangerous, in particular that SSRI antidepressants can cause suicide and violence. Later, she took offence against a blog I wrote about her and sent me a solicitor’s letters for my troubles. I then published the letter saying I would not be bullied or intimidated by Lundbeck or anyone else – so she sent me another one and I published that too. I think you know you’re on the right track when you get a ‘Casey Correspondence’.

Q: Congratulations on graduating with a law degree. It's a wonderful achievement. What made you decide on studying law?

A: I started studying law the year after Shane died. I basically wanted to find out how the pharmaceutical companies were getting away with harming people on this side of the Atlantic, when in the U.S. cases are regularly settled or the pharmaceutical industry are found guilty. Same drugs, same humans but warnings provided in the U.S. and none here – it’s a ridiculous situation. There will be no accountability until the legal system and our governments takes steps to sanction wrongdoing by these enormous companies. At the moment companies like GlaxoSmithKline and Lundbeck are being permitted to run rough-shod over Europe. The law degree helped me to understand the situation, but not accept it. I should say though, that I thoroughly enjoyed every second of doing law with my lovely colleagues and lecturers -  it was a great distraction.

Q: Would you recommend blogging to parents, or anyone for that matter, who had lost someone dear to them through antidepressant induced suicide?

A: I certainly would. Apart from being another great distraction, it’s a cheap form of therapy. It helps to get things in perspective and enables many diverse conversations. I do know that my family was helped enormously by other bloggers, particularly you and Truthman. It’s such a huge revelation when you find others in a similar situation, having thought you were alone. Sadly, there are many more victims and bereaved families since – yet, as there are more experts willing to speak out (Peter Gøtzsche for example), I think positive changes are coming fast.

Q: As an outsider looking in (kind of) I am amazed at your commitment and tenacity. What is it that keeps you going?

A: That’s easy – Shane. He was just so lovely, kind, funny and caring. I think of him every second of every day and the injustice of his death keeps me going. He was very like me and would have fought many injustices in his 22 years. I believe with every fibre of my being that Shane died because of Citalopram.  Therefore, I could never have moved on, taken the other option - to live a relatively easy life, albeit one without Shane.  To do that would have been to actively enable similar deaths to happen to others. It was never an option. It helps that there are so many of us in the same boat, helping each other out.

Q: Have you ever considered writing a book about your journey?

A. I have and it’s about 2/3 of the way finished. It’s just a matter of time, which I never seem to have enough of. The goalposts keep moving, with so much emerging pharmaceutical information. Shane’s personal story is fighting with my academic side and I’m trying hard to marry both and still keep it interesting.

Q: What do you say to people who believe that antidepressants are safe and effective?

A: Some people seem to be able to take antidepressants without coming to any harm. Whether through the placebo effect, or otherwise, some say they are helped by them. There are many reasons for this, not least that people usually get better with or without medication. Nevertheless, we know that these drugs are neither safe nor effective for the majority of people that take them, with experts saying they are causing ‘more harm than good’. We know they can double the risk of suicide and violence, cause mania, increased depression and a myriad of other harmful effects, including heart problems and stroke (causing many fatalities). Two innocuously-sounding effects that fascinate me are emotional-blunting and disinhibition – effectively meaning that a huge percentage of people could be walking around with sociopathic tendencies. No doubt future generations will look back and see this era of mass-prescribing, as ludicrous. I would advocate vehemently for fully-informed-consent, a practice sadly lacking in Europe.

Q: I see from your Facebook profile that you have an annual dip in the river each December. Can you tell me more about that and other charity work that you are involved with?

A: My family do the Christmas Day swim in Sandycove every year, to raise money for the Simon Community. I don’t if I can get away with it and instead, I pay to get out of it. I spend from January to December dreading it, so I bribed Tony into doing it last time and happily looked on from the side-lines at all the blue bodies. For some strange reason, one that I could never fathom, my mother, brothers, sisters and cousins love jumping into the freezing Irish sea – I don’t.

Q: When I spent time with you and Tony in Ireland you told me about Shane's gesture on his 21st birthday. (Church) For the benefit of this Q&A can you tell the readers about this wonderful gesture?

A: It wasn’t the church, it was the St Vincent De Paul, a charity he was very fond of - he worked there as a volunteer. Shane was very kind-hearted, always eager to help those who were unable to help themselves - so much so that he was referred to by his lecturers as ‘an chroi mór’ (Irish for the big heart). For his 21st birthday party in 2008, Shane asked everyone to make a donation to the St Vincent de Paul rather than buy him a present.  He told everyone he didn’t need presents, that he had everything he could possibly need.  He wrote the following words on his official 21st party invites...

“…despite the fact that my parents neglect me [joke], believe it or not I am spoiled.  So instead of spending money on a card or anything else, please make use of the St. Vincent de Paul box on the night where you can give the money to someone who needs it as I have everything, thanks. Shane”

Q: For you, what is the most frustrating part about being a patient advocate?

A: What frustrates me most is lackadaisical journalists who come looking for newspaper fodder. They often look for contacts details (of medical experts and bereaved parents) and I’ll happily do what I can to help. Occasionally though, they look for ‘all the up-to-date evidence’ and I can spend days doing research, effectively doing their job for them. Nevertheless, I persevere just because I’m thankful that iatrogenic harm will be discussed – how sad is that? I wish there were more good scientific journalists, who would use their own initiative and do their own research. We could do with some good medical and science writers over here – I wonder could we adopt Robert Whitaker or Mikey Nardo?

Q: Where do you see yourself in 10 years time?

A: Besides pottering around Wicklow with Tony, having recovered from the empty-nest syndrome and if I haven’t kicked the bucket, I see myself teaching Pharma-Ethics (unethical ethics), or something similar. I hope to put my years of studying, research and life-experience to good use and have many projects in the pipeline. However, I wouldn’t have predicted living the life I now lead, so who knows?

Q: Finally Leonie, some personal questions...

1. What book are you currently reading?

A: I’m studying at the moment, so the book that comes everywhere with me is ‘Principle of Biomedical Ethics’ by Beauchamp and Childress. It’s actually not as bad as it sounds.

2. What was the last CD you listened to (in full)?

A: The Best of John Denver (in the car while I waited for the boys to come out from Jiu-Jitsu training).

3. What is the best movie you have seen this year?

A: ‘Daddy’s Home’ with Will Ferrell and Mark Wahlberg (in the cinema with my 17-year-old son Jack). Absolutely Hilarious - although I think Jack was a little mortified in certain parts.

4. What country would you most like to visit?

A: Italy. We went for a day-trip to Ventimiglia last year (from Monaco) and it was just so incredible. It made us want to return to see more: the old buildings, the markets, the food, the people, the sun, the double decker trains –  sweet memories!

5. If you had the choice of being either a defence or prosecution lawyer, which would you choose and why?

A: Not sure I understand the question, a good lawyer should do both I think. While we’d all love to change the world like Erin Brockovich, if the defending lawyer doesn’t defend the accused to the very best of his ability (particularly if he believes him to be guilty), that may leave the option open for a re-trial or a mistrial. We can all have subjective opinions, but a good legal system should be based on objectivity. HOWEVER, I can’t say I’d be very objective if I was to represent a victim of the pharmaceutical industry.



Leonie Fennell Blog

Leonie's Twitter Page



Bob Fiddaman



Previous Q&A's

Q&A With Ablechild's Sheila Matthews-Gallo

She Feckin Did It!

Imagine waking up Sunday morning to a knock on your door. Your Saturday night quickly forgotten as you open the door and are greeted by the Police, in this instance it was the Irish Garda (An Garda Síochána)

They ask you if you know the whereabouts of your son, furthermore, they tell you that he was involved in an incident where someone was killed.

What would your reaction be?

As your Sunday unfolds you are once again contacted by the law enforcement of your particular country. "Your son," they tell you, "has been found." They continue, "I'm sorry to inform you that your son is dead."

Just comprehend the above scenario. I've tried but plummeting myself into such a scenario really means nothing. Rik Mayall is on my TV, I don't need to put myself in anyone's shoes to feel their pain. I have potatoes on the hob boiling - why would I want to paint a picture of someone else's problem?

Leonie Fennell is a friend, more importantly, she is a mother. It was she that endured the above scenario, along with her husband, Tony.

I've heard them both relive that day and felt sickened. It would be a lie to say I felt their grief, how could I, how could anyone? Yes, of course, as a human I felt their pain, at least a very small amount of it. It's a pain that both Tony and Leonie carry around with them every day.

As the years have rolled on their nightmare has been rehashed in various newspapers and documentaries. Their dead son, Shane, has been labelled and mocked even though an inquest on his death returned an open verdict. This, after it was learned, that Shane stabbed himself in the chest 19 times after fatally wounding a young Irishman.

Psychiatrists, who, in the main, make their name through column inches in the press, have offered their opinion. Shane had a mental illness, he was driven to a mad rage of jealousy, etc, etc, etc.

These same interfering white-coated buffoons ignore the suicide/homicide link related to the drug Shane was taking at the time, Cipramil (citalopram) - marketed in the US as Celexa.

Anyway, I don't want to dwell on the past. Shane's story (the honest truth) can be read on Leonie's blog (link at the end of this article)

So, to the title of this post, "She Feckin Did It!"

Well, I can imagine Leonie now, speed reading through this piece of mine, uttering under her breath words such as 'fecker'. She'd be embarrassed by it all.

You see, despite suffering the heartache of losing her son, despite having fingers pointed at her and her other children, despite the chin-wagging of those that never really knew her son, Leonie has battled on. A popular blog, threatening letters from lawyers representing an Irish psychiatrist and even a trip across to Denmark to visit Lundbeck, the manufacturers of the drug that killed her son, a meeting that was covertly recorded too - much to my delight :-)

So, what do you do when something as hellish as losing a son in such a bizarre manner?

Leonie did what she was driven to do and now she has graduated with a LLB (Legum Baccalaureus or Honours Bachelor of Laws) from ITCarlow.

Leonie set out five long years ago on a journey, she writes...

Five years ago I ventured out of my comfort zone as a scared, scarred and grieving ‘40 something’ – as a third level rookie. I had decided on a ‘Foundation in Law’ course in Dublin’s Institute of Technology, Aungier Street, more by accident than any foregone design. Having attended an information evening (and handing over my Visa card), before I could utter “erm, not quite sure…”, I was duly plonked on a chair and photographed. Soon afterwards I found myself standing on the steps of DIT with a student card in hand, complete with obligitory dodgy student photo. I wasn’t sure whether to laugh or cry, but when I adjusted to the shock – it turned out to be one of my better decisions (the course, not the photo).

The whole story, ITCarlow – My Alma Mater, can be read here.

It's quite an achievement to pass any sort of course, particularly in that of law, which frankly is a mindfield of mind-boggling rules and regulations that we must all, apparently abide by.

I like Leonie's style, not her fashion sense, last I heard she was still wearing flared trousers and tartan scarves around her wrists. I just like her approach to blogging, her approach in offering support to those who need it, her approach to life in general.

Leonie is a funny woman, full of that stereotypical Irish wit. It's a pleasure to know both herself and Tony and their beautiful children. It's also my pleasure to publicly say, Leonie, you feckin did it!

Eiridh tonn air uisge balbh.


Bob Fiddaman.

Celexa and Lexapro Refunds

A federal judge has ruled that parents, whose children were prescribed the antidepressants Celexa [citalopram] and/or Lexapro [escitalopram] are entitled to refunds.

Forest Laboratories and its subsidiary Forest Pharmaceuticals, have agreed to shell out up to $10.4 million in refunds.

Back in 2010 Forest  pleaded guilty to federal charges that its sales force team illegally marketed Celexa and Lexapro for use in children and teenagers when they knew that both drugs were only approved by the FDA to treat depression in adults. According to the charges, Forest bribed doctors with cash, meals and travel in efforts to persuade doctors to prescribe the drugs to children.

Why aren't we surprised by this anymore?

Once again we are seeing a pharmaceutical company quietly settle matters, once again there is no jail time for any of the executives, once again money is thrown at the problem.

The 2010 charges also allege that Forest covered up the negative results of their pediatric trials.

So they knew their drugs were no better than placebo yet still targeted doctors to prescribe them to kids.

Anyone familiar with the story Hansel and Gretel?

Dr. Greg Mattingly with his wife Judi

Dr. Greg Mattingly, a psychiatrist in St. Charles, was also named in court documents as one of the country’s top prescribers of Celexa. Evidence shows notes made from a phone call with Mattingly and a Forest sales representative where he agreed to include information about Celexa for children into his talks. Mattingly is alleged to have received more than $107,000 from Forest Pharmaceuticals in meals, travel and speaking fees in 2012 and close to $38,000 in 2013, according to trial documents.

Dr. Brian D. Barash

Dr. Brian Barash, a Kansas City psychiatrist and chief medical officer of the Marillac Children’s Psychiatric Treatment Center, was paid “thousands of dollars to give dozens of speeches to Missouri doctors about Celexa,” according to trial docuuments.

Take a good look at the photos above. Both have, it seems, been promoting drugs that not only don't work in children but drugs that are dangerous for children.

Forest has already agreed to pay out $313 million to settle allegations with the government and millions more in dozens of personal injury lawsuits.

• 13-year-old Andrew Tradd of Massachusetts, who died of a brain injury days after he tried to hang himself in 2004, two years after being prescribed Celexa. 
• The family of Danielle Henrikson, 15, sued the company after she hanged herself in her Idaho home the same year, weeks after starting the drug. 
• Alex Kim of Georgia, hanged himself in 2004 after his dosage of Lexapro was doubled.

Full article, 'Parents can get refunds for some anti-depressant drugs given to kids', here.

Celexa is known in the UK as Cipramil. Lexapro uses the brand name Cipralex in the UK.

Both drugs are also under scrutiny for causing birth defects.

More on the settlement agreement here.

Bob Fiddaman.

GUEST POST - The Lundbeck Runaround

The following is a guest post from Cheryl Buchanan. Cheryl has previously written a guest post on this blog [link at bottom] - this is an update regarding her mission to seek the truth from Lundbeck, a Danish pharmaceutical company who manufacture the antidepressant citalopram, known by its brand name of Cipramil and known in the US as Celexa.

It's worthy to note that both citalopram and its sister drug, escitalopram, are both the subject of litigation in the United States. For further information please visit Forest Illegally Promoting Antidepressants for Kids!


GUEST POST - The Lundbeck Runaround

Back in December Bob Fiddaman very kindly invited me to write a guest post for his blob. I had contacted him after finding his blog while scouring the Internet for information about anti depressants and birth defects. I had just discovered that before, and during, the time of my first pregnancy in 2004 I had been prescribed the SSRI antidepressant citalopram. My daughter was born at 23 weeks gestation, she had multiple abnormalities and was incompatible with life.

Upon speaking to Bob I sadly discovered I was not alone and that there have been many women whose children developed birth defects in pregnancy while their mothers were taking citalopram and other SSRIs.

At the time I was assured it was safe and was wholeheartedly encouraged to keep taking it. I was on a very high dose (60mg) which is no longer prescribed as its known to cause long QT syndrome in adults.

It has now also been proven that it can cause birth defects, especially those related to the heart and abdominal wall. My daughter had no diaphragm and other abnormalities, all of the details are included in my previous guest post 

I have been in contact with Lundbeck to ask them a series of questions, in the beginning they were more that happy to accommodate, every email was replied to promptly. That was until the chat I had with Bob where we decided it was a good idea to copy Bob in on all the correspondence between myself and Lundbeck. It appears Lundbeck did not like this.

The first email I sent, with Bob cc'd, went unanswered. I waited a good few weeks but still nothing, I gave them the benefit of doubt and emailed again just in case they hadn't received it but yet again, no reply. Bob also told me that he had noticed an IP address he did not recognize had visited his blog, he decided to trace the IP and yep, you've guessed, it was Lundbeck in Copenhagen. By now I was getting majorly pissed. I decided to call Lundbeck and ask why they hadn't answered. This is the conversation that followed.

Conversation with Lundbeck employee 1.30pm 22/07/14

(CB - me, LU - Lundbeck)

CB - Hi can I speak to Ms Warrilow please?

LU - I'm sorry but she is not in today, it is anything I could help you with?

CB - Maybe you could but I'll have to explain the situation I'm in first.

LU - OK, go ahead.

CB - Back in 2004 I had a baby who developed severe abnormalities, she was incompatible with life and passed away at 23 weeks gestation. I was prescribed Citalopram at a dose of 60mg prior to, and during pregnancy. My GP knew I was trying to conceive and prescribed folic acid to me.

I was also told by more than one GP at my surgery that SSRI antidepressants were safe. I have a fair feeling citalopram caused my daughters birth defects. I had been in correspondence with Ms Warrilow who was answering some questions I had. We were in contact for several weeks but I have not had a reply to the last email I sent with a question, this was in December, or any subsequent emails asking why I was not being replied to.

LU - Oh, that's strange, maybe the question you had didn't have an answer. Why do you seem to think citalopram caused the birth defects, that's not a question there is an answer to, that's like asking if the sky is blue.

CB - I want to know because I am her mother and at the time no cause was found for her problems, she had normal chromosomes. I know from researching that SSRI's can cause birth defects.

LU - We recommend that the patient speaks to their GP, that is our guidance.

CB - I am way beyond "Speaking to my GP", I have had a meeting with the Clinical Director of the maternity hospital my daughter was born in, its in my records that he sent a yellow card warning to the Centre for Adverse Reactions in Scotland about the adverse reaction to Citalopram.

LU - When was this again, 2004, Oh I don't know if you will get any information, it was a long time ago.

CB - I have contacted the MHRA as my consultant contacted them. I wanted to ask if they had any information.

LU - The MHRA won't have any information, all reports are anonymous. I don't understand why you want to know, there is nothing that can give you a definitive yes or no.

CB - Would I be better contacting Lundbeck in Denmark directly? Or is there someone else I could speak to?

LU - Why would you want to do that, Eve already told you, we recommend you go back and see your GP.

CB - So all of this is my GP's fault for prescribing it?

LU - We tell the GP's to read the PIL, and the information we give them, and make their recommendations from that.

CB - But did the PIL or your information for GP's state the risk of birth defects in babies back in 2004?

LU - Oh we never recommend prescribing antidepressants in pregnancy, no studies have been done.

CB - There are other SSRI's, paroxetine being one, which is known to cause birth defects, I know citalopram is a category C, paroxetine is D.

LU - Oh, but we still do not recommend it in pregnancy.

CB - When will Ms Warrilow  be back?

LU - Tomorrow, what is your name and I will get her to contact you?

CB - Cheryl Buchanan, I have emailed a couple of times and had no reply.

LU - It must be the spam filter, we have been very busy and maybe just haven't gotten to your emails.

CB - It is possible its because I have copied Mr. Bob Fiddaman in on the correspondence? He has been giving me help and advice and has a lot of knowledge about SSRI's. He also has a blog and told me his blog has been visited a number of times by an IP he did not recognize, after checking it he found it belongs  to Lundbeck in Denmark so I think that you have been receiving my emails.

LU - I don't know anything about it. I will have Ms Warrilow contact you. Are you still taking Citalopram?

CB - No.

LU - Are you on a different SSRI?

CB - Yes but I am withdrawing from using it as I will not be a hypocrite and take something which more than likely killed my daughter.

LU - Are you doing this under GP's guidance.

CB - Yes. Thanks you for your time. Goodbye.

LU - No problem, bye.

I was dumbfounded. I awaited a response but once again was ignored. So I waited some more, just long enough for them to think I had gone away.

Then I called their head office again, this time the person who answered the phone was the one who I'd been speaking with by email.

Conversation with Ms W (Lundbeck) 17/02/14 - 4.30pm

CB - Hi can I speak to Ms Warrilow please?

LU - This is her speaking...

C - Hi, I am not sure if you know who I am but my name is Cheryl Buchanan, I was speaking to you through email a couple of months ago, about my daughters birth defects?

LU - Yes, I do remember

CB - I sent you an email back in December and I never got a response, I have since then emailed you several times and never got a reply.

LU - Oh, er, I think that was because there wasn't really anything else we could say to you.

CB - I understand that but it would have been more courteous if you could have replied telling me that, this situation is consuming my life at the moment and having to send repeated emails, with no answer, it doesn't help.

LU - Oh, yes, I do apologize.

CB - I actually called a couple of weeks ago and spoke to a colleague of yours, she took my details and assured me she would have you contact me.

LU - Oh, erm...

CB - I hope you understand I'm not blaming you personally, I know its absolutely nothing to do with you but a reply would have been helpful, even if to say you didn't have anything else to tell me.

LU - (Silence)

LU - The MHRA have been in touch with us, you asked in your email if they contacted us in 04, they didn't but have since, they might be able to help you. Would you like a copy of the information they sent us? It is anonymous but we figured it was you.

CB - I filled in another yellow card a couple of months ago and asked for them to contact me, I never got a reply, I imagine they have contacted you about the Yellow card I sent recently. If you could send me a copy of what they sent you I would really appreciate it.

LU - OK, that's not a problem.

CB - Can I ask a question? Do you know what the PIL stated about prescribing citalopram in pregnancy back in 2004, or could you find out? What I'm trying to figure out is if GP's would have known citalopram was a teratogen back then?

LU - I can get a copy of it, I'm sure it said use with caution but I can find out for you and send a copy of the 04 PIL to you.

CB - Do you know when the risks of prescribing in pregnancy were was added to the PIL, was it 2004?

LU - I'm not sure, the PIL changes all the time.

CB - I'm trying to figure out if GP's would have known Citalopram was a teratogen.

LU - I can get you a copy of the GP information and send it to you? I'm sure it would have said use with caution in pregnancy.

CB - That would be great

LU - Do we have your address, I don't think we do?

CB - No you wouldn't have, all our conversations were by email. (I give her my address)

LU - I will get that sent to you tomorrow, do you remember us sending you a permission form for you to sign so we can contact your GP?

CB - Yes but I don't have a printer so can't return it, could you send me a paper copy please?

LU - Of course, Ill get it send out to you along with the other information.

CB - Thank you for your time, bye.

LU - Bye.

While I had been awaiting a reply I decided to complain to the MHRA about Lundbeck's lack of response, just today they sent me a reply which seems to have been written by a robot and in no way at all answers the complaint I put to them.

Dear Ms Buchanan,

Thank you for your email regarding the lack of response from Lundbeck and your concerns regarding the product Citalopram. We are very sorry to hear about what has happened to you and your daughter.

Your email was treated as a patient report and we were as a consequence able to link this up with your previous correspondence with the Vigilance and Risk Management of Medicines Division.

In relation to Lundbeck your information has been passed to the Inspection, Enforcement and Standards Division who have responsibility for conducting Pharmacovigilance inspections of Marketing Authorization Holders (MAHs) such as Lundbeck. This information will be entered into the risk information system; this system is used to determine how often organizations are inspected. At such inspections we check how the MAH handles reports such as your own as they have responsibility for the on-going safety of products on the market. During any such inspection we do of course preserve the identity of any individuals such as yourself.

Once again, thank you for alerting us to this potential adverse reaction and the actions of the company.

Kind Regards,

Customer Services External Relations Medicines and Healthcare Products Regulatory Agency

Right now I am furious. This morning on my daily hunt of the net for info I was on Lundbeck's LinkedIn page. In the careers section their is a large photo header with the statement "Everyone deserves quality of life". How completley and utterly hypocritical. What about my daughters "quality of life"?

Because of a medication, made by them, which they knew in studies killed of the fetuses of pregnant rats and they marketed as being safe in pregnancy, my daughter is dead. She never got a chance of life. So Lundbeck, if you are reading this, please know that I'm not going to go away. I will keep doing my utmost to prove your are responsible for my child's and hundreds, possibly thousands, of other children's birth defects.

I have had several women come to me in the past few of weeks to tell me their story and how their children were born with birth defects after taking SSRI medication. I am not only doing this for my child, but for all the children whose lives have been damaged by your drugs.

To Bob Fiddaman, thank you from the bottom of my heart.


Back Stories

Citalopram Birth Defects (Guest Post)

The Lundbeck Emails [Citalopram Birth Defects]

A Message From RxISK

Have you developed visual problems on anti-depressants, or when stopping them? RxISK.org are looking for those that have.

http://wp.rxisk.org/keeping-an-eye-on-the-ball-visual-problems-on-ssris/

Although the person in the article lists a number of visual symptoms, it is worth noting that their main problem is blurred vision and poor night-vision.

If you experience these problems, please get in touch.

We're very keen to hear from SSRI users, but we would also be happy to hear from other anti-depressant users. You don't have to be based in the UK, providing you can arrange the same testing.

We need to get this message out to as many anti-depressant users as possible. Please help us to spread the word.

Many thanks.

James Bennett (assisting RxISK.org)

The Lundbeck Emails [Citalopram Birth Defects]

Two weeks ago Cheryl Buchanan wrote a guest post for this blog entitled 'Citalopram Birth Defects'.

Cheryl told how, after just 12 weeks, she was informed that the child she was carrying had a series of anomalies. Cheryl wrote:

The most severe of which included suspected diaphragmatic hernia or eventration, long bone immobility (I had never felt her move but as this was my first pregnancy I didn't know, I had nothing to compare it to), a cystic hygroma, unilateral cleft hand and microgynathia. I was also told that she might have brain damage which would explain the fact she didn't (or possibly couldn't) move.

Lundbeck are the manufacturers of citalopram, also known by its brand names Cipramil and Celexa, and Cheryl felt compelled to write to them for answers. Who can blame her?

I'm publishing Cheryl's emails with her permission. I don't need permission to publish Lundbeck's responses.



Nov 4 - Cheryl to Lundbeck

Dear Sir or Madam,

I am contacting you regarding the death of my daughter in 2004. I was taking citalopram at 60mg and became pregnant, I was told to continue the citalopram (it's physically written in my medical records) and as such my daughter whom I was pregnant with developed major abnormalities which meant she was incompatible with life. She died at 23 weeks gestation as I had to have a feticide procedure and induced Labour. I have recently come to believe upon gaining access to my medical records that citalopram was to blame and I have several questions I would like to ask your company. If someone could reply to me I would be very grateful, I plan on acquiring as much information as possible and have done a lot of research and spoken to other people who's families have been affected by citalopram. I have also spoken with some journalists who, if I give consent, plan on publicising my case in the newspapers in Scotland. I hope lundbeck are going to take my questions and claim that your drug was to blame very seriously. My daughter is dead because of this and I will not stop until I get the answers I deserve.

Cheryl Buchanan
File(s) attached

----

Nov 5 - Lundbeck to Cheryl

From: UKInfo@Lundbeck.com
To: REDACTED
Date: Tue, 5 Nov 2013 18:04:37 +0100
Subject: FW: Email sent from Lundbeck.com

Dear Ms Buchanan

I am just following up concerning your recent email to us on.  You mentioned that you had a number of questions you'd like us to respond to, however, as yet we haven't had an email from you with the questions on, and I was just wondering if this had gone astray on its way to us?  If you send any future emails or request to our Medical Information mailbox in the UK (ukmedicalinformation@lundbeck.com) we will be happy to address the points that you needed information on.

We can understand your reluctance for us to write to your doctor at this time.  However, I wonder if we could ask for one small piece of information?  In your email to us at the end of last week, you mentioned that when you obtained your records your doctor had reported the case to the MHRA.  Would you happen to have a case reference number for this that would be possible to let us know at all?  As mentioned in my email of last week, we do treat any report of unwanted effects seriously and have a obligation to also follow them up and obtain as much information as possible.

With kind regards

Medical Information Manager

Lundbeck Ltd, Lundbeck House
Caldecotte
Milton Keynes
BUCKS MK7 8LG
Tel: 01908 638972
Fax: 01908 372967

----

Nov 8 - Cheryl to Lundbeck

From: REDACTED
Sent: Friday, November 08, 2013 3:10 PM
To: UK Medical Information
Subject: RE: Email sent from Lundbeck.com

Dear Lundbeck, these are the questions I would like answered with regards to my daughters death while taking Citalopram.

1. Were Lundbeck contacted by the MHRA after being sent the Yellow Warning card by my consultant at the Princess Royal Maternity hospital in 2004?

2. What is the process when an adverse reaction of this nature is reported to Lundbeck?

3. Do Lundbeck ever follow up these reports and, or, contact the patient involved?

4. In the time leading up to 2004 (the year of my daughters death) there were 16 adverse reactions reported for congenital and familial /genetic disorders.

By September 2013 according to the D.A.P. for Citalopram the reported side effects of congenital disorders had risen to 82. 5 of these cases were stated as "fatal".

Also in the "pregnancy" section of the report 6 fatalities implicating citalopram were also recorded. So, according to the information stated in the D.A.P. Citalopram was an indicated factor in the death of 11 babies. One of which being my daughter. Very sadly, I also read that there were 20 "spontaneous abortions", four premature birth ands 2 still births. So that brings the total to 13. This is only the totals of cases which have been reported through the yellow card system to the MHRA, what about the cases that do not get reported, for instance if the woman was only on citalopram in early pregnancy, for example up to 4 - 6 weeks, finds out she is pregnant, stops this drug but subsequently in later pregnancy finds there is fetal abnormalities or that their baby has passed away. Do you have any idea, on average, of what percentage of suspected adverse affects are reported by the primary caregiver of the woman? There must be many cases where the medication was stopped very early on and then if abnormalities are found the drug citalopram is not indicated as it was stopped earlier in the pregnancy or, even if it was suspected, it was not reported to the MHRA. I understand it is not compulsory.

5. Has Lundbeck recently done, or plans to carry out, any studies into the iatrogenic affects of their medication?

6. If Lundbeck believe that citalopram does not cause birth defects then why have warnings been been introduced into the P.I.L.?

"When taken in pregnancy, particularly in the last 3 months of pregnancy, medicines LIKE citalopram may increase the risk of a serious condition in babies, called Persistent Pulmonary Hypertension."

PPHN is classed as a birth defect or congenital abnormality. My daughter suffered from Pulmonary Hypoplasia due to Diaphragmatic Hernia. This is closely associated with PPHN.
 
According to the website ChildrensColarado.org
       
"PPHN sometimes develops as the result of another event during delivery or from a disease or congenital condition affecting the newborn (usually one that either directly affects the lungs or oxygen supply to the baby before or after birth)."
       
"Certain congenital conditions that result in immature or incomplete lung development (such as diaphragmatic hernia) may also be associated with PPHN."
 
So basically, you could say by theory of logic, my daughter had no diaphragm and her lungs were less than a third of the size they should have been for her gestation, this would have more than likely caused PPHN, which is stated on your P.I.L. as being an "adverse reaction" to your medication Citalopram. So not only did your medication cause my daughter not  to develop normally, (which isn't really suspiring considering I was told to stay on it and at a dose of 60mg which is horrendous to think about), it would have contributed to my daughters demise had she been born alive. Neither myself or my partner have any history in our families of miscarriage, still birth or congenital (or hereditary) abnormalities or syndromes. As my daughters Karotype was normal this rules out tow of the three main factors. The last one is environmental which would include subjecting the much loved and wanted fetus, growling in my tummy, to a horrific amount of serotonin, an amount which has been proven to be unsafe in fully grown adults. Do you have an explanation for this and why it was deemed to be safe for a pregnant woman when it is not prescribed to adults at this dose anymore? I was not informed of any side effects of this drug by anyone, at any point in my care, I was told it was safe by numerous healthcare professionals.

7.  I have read a lot about the "benefit outweighing the risk". I don't see how a mother, whoso depression has been under control for a long time, she is happy and looking forward to the birth of her newborn, can benefit by being prescribed a drug, which then goes on to cause major abnormalities, weeks of tests, scans and hospital visits, all the while being absolutely devastated and clinging on to every hope her child would be OK and spending every night forcing herself to stay awake as she was so scared her baby would die, talking and singing to her baby, telling her baby how much she loved them and how sorry she was that she could not protect her baby, Contacting specialists in hospitals all over the UK to finally have to death with the death of her child and go through induced labor knowing that her child is dead, and then to see all of the malformations her beautiful angel had, and to have to live with the loss and huge hole in her heart every second of every day, blaming herself, torturing herself with guilt... What benefit did citalproam give this mother. I know the answer. None, that mother is me. This drug destroyed my daughters life and left an irreplaceable whole in my heart which will never heal until I join my daughter in heaven. So please, tell me again, what was the benefit?
   
I would be very grateful if you could answer my questions as honestly as possible, but to be honest I don't hold out much hope. I just want you to understand the "adverse reaction" your drug has had on my life.
   
I have lived with this "adverse reaction" every day for the past nine and a half years and will continue to live with it till the day I die.

Cheryl Buchanan

----

Nov 8 - Lundbeck to Cheryl

-----Original Message-----

From: UK Medical Information
Sent: 8 Nov 2013 16:58:05 GMT
To: REDACTED
Subject: RE: Email sent from Lundbeck.com

Dear Ms Buchanan

A quick note to confirm that I have received your questions this afternoon. I have forwarded these on to our global safety team at our headquarters in Copenhagen, and we will give these our full attention and should be able to get back to you with a response, early next week.

With kind regards

Karen Warrillow

----

Nov 13 - Cheryl to Lundbeck

From: REDACTED
Sent: Wednesday, November 13, 2013 5:24 PM
To: UK Medical Information
Subject: RE: Email sent from Lundbeck.com

Dear Lundbeck,

I am writing to ask if there has been any response from your safety team in Copenhagen yet? The reason I ask is you had stated in your last email to me that I would receive a reply early this week, tomorrow is Thursday and I am very anxious for a reply. I have been speaking with the MHRA and UKTIS and I am awaiting a response from them too. If it is going to take longer than first anticipated that is not a problem but either way if you could let me know what's happening I would really appreciate it, thank you.

Cheryl Buchanan

----

Nov 14 - Lundbeck to Cheryl

From: UK Medical Information
Sent: 14 Nov 2013 09:47:06 GMT
To: REDACTED
Subject: RE: Email sent from Lundbeck.com

Dear Ms Buchanan

I apologise that I have not been able to be in touch as I had hoped, earlier in the week.  I am still awaiting for some information from our global team and also from the MHRA in order for us to be able to fully answer your questions.  I would hope that I should receive this information later today, so I can put the information together and send a response to you tomorrow.

Karen Warrillow
Medical Information Manager

Lundbeck Ltd, Lundbeck House
Caldecotte
Milton Keynes
BUCKS MK7 8LG
Tel: 01908 638972
Fax: 01908 372967

----

18 Nov - Cheryl to Lundbeck

From: REDACTED
Sent: Monday, November 18, 2013 12:21 PM
To: UK Medical Information
Subject: RE: Email sent from Lundbeck.com

Dear Lundbeck,

I am writing to ask if there has been any progress on your reply to me regarding the questions I had sent you? I don't like to keep bothering you but I was told I would have had a reply by early last week. I know you were waiting on information and was wondering if you received it yet? If not that's fine but I am suffering from quite a lot of anxiety at the moment, due to this situation and also the fact I am trying wean myself off of an antidepressant as I will not be a hypocrite and take something which more than likely caused my daughter's problems. Having been on prescribed anti depressants since the age of 14, and only having stopped them for the period of my second pregnancy, that is 20 years I have put this medication into my system and I do not know how well my brain is going to function but we shall see. I find it appalling, now knowing what I know about ssris, that I have been encouraged to take something for a "chemical imbalance" in my brain which has not even been proven to be a cause of depression ect. I am suffering with horrible withdrawal symptoms and if the medication can cause this upon stopping them then what must they be doing to your brain to cause this. If you could let me know if you have a timescale in which you plan to reply it would be greatly appreciated.

Cheryl Buchanan

----

18 Nov - Lundbeck to Cheryl

From: UK Medical Information
Sent: 18 Nov 2013 16:11:25 GMT
To: REDACTED
Subject: RE: Email sent from Lundbeck.com

Dear Ms Buchanan

Please forgive the further delay in getting information across to you.  I have now received all the information back concerning your questions, and am just collating this for you.

I will make sure you receive a reply tomorrow.

With kind regards

Karen Warrillow

----

Nov 19 - Cheryl to Lundbeck

Date: Tue, 19 Nov 2013 15:33:53 +0000
Subject: RE: Email sent from Lundbeck.com
From: REDACTED
To: UKInfo@Lundbeck.com

Hi, just wondering if you have gotten any further on with regards to a reply to me questions?

Cheryl

----

Nov 20 - Lundbeck to Cheryl

-----Original Message-----

From: UK Medical Information
Sent: 20 Nov 2013 17:18:08 GMT
To: REDACTED
Subject: Information relating to citalopram (Request ID 0005-8858, UK 8637)

20th November 2013

Dear Ms Buchanan

Thank you for your recent emails.  Firstly, I would like to say how saddened we were to hear of your experiences.  I have addressed the questions that you raised, and hope that the information below helps to clarify things.

The methods of collecting and reporting safety data about medicines available in Europe are governed by Pharmacovigilance Regulations issued by the European Medicines Agency. I am sure you will probably have already done this, but you might find it helpful to have a look at the MHRA's information on the Yellow Card Process; this includes information on how reports are handled and what is done with the reports. This can be found at the following link; http://yellowcard.mhra.gov.uk/faqs/ .

Adverse events assessed as 'serious' reported by healthcare professionals and patients to the MHRA via the yellow card system are normally forwarded to the company responsible for inclusion in the company's safety database. The reports are anonymised by the MHRA before forwarding to us, so we are unable to then make contact with the patient concerned or the reporting healthcare professional. All pharmaceutical companies also have a process in place to forward on to the MHRA any reports received directly from healthcare professionals or patients . We also collect information on any cases of exposure to medicines during pregnancy, and whether or not problems are reported.

Periodically, at intervals specified in the safety regulations, companies must also submit a summary report of all safety-related information which has come to their attention, including reports of usage in pregnancy, to the regulatory authorities in the countries where a product is available (i.e the MHRA for the UK). The authorities review this information and make recommendations on whether the prescribing information (SPC & PIL) should be updated to include any information on newly identified possible side effects. The authorities may additionally sometimes request that SPCs are updated to incorporate new information which comes to light in the published literature about the medicine or similar products . In this way the SPC is a living document which at any one time reflects the currently known information about a medicine.

When looking at the figures provided in the Drug Analysis Prints (DAPS) on the MHRA website, it is very important to be aware that the figures listed are not necessarily cases where the event is specified as being causally-related to the medicine in question, in this case citalopram. The MHRA state themselves in their guidance notes about DAPS; "The fact that a report has been submitted does not necessarily mean that the medicine has been proven to cause a reaction." The listings do not provide further information about the cases reported which also need to be taken into consideration, such as any medical conditions the patient might have or details on other medicines taken, or take into account the likelihood that all of the events listed are also reported in the general population.

To put this information into context a little we know that worldwide more than 140 million patients have been treated with Lundbeck-manufactured citalopram over a 20-year period (and many more when generic preparations are included). This large volume of data includes cases of usage in pregnancy and through our frequent analysis and evaluation of this data reported to the company, and regularly forwarded to the drug regulatory authorities for their assessment, there is no evidence to indicate that usage of citalopram in pregnancy increases the risk for birth defects over the background risk. There are a number of reviews which have been published in the scientific literature which support this finding.

You are correct in stating that fairly recently we have added information on PPHN into our leaflet for Cipramil. This occurred in July 2010 and was the result of an assessment by the European Regulatory Authorities who evaluated three new epidemiological studies published in the scientific literature. These evaluated the pattern of PPHN occurrence across large defined populations and generated evidence to support the conclusion that the use of SSRIs in pregnancy, particularly in the later stages, may increse the risk of PPH in the newborn. PPHN may be casued by a number of factors, not necessariliy related to malformations and although the risk of PPHN is still very small, the risk is slightly increased in babies born to mothers taking antidepressants, such as SSRIs. Consequently the same wording was introduced to the pregnancy section for all the SSRI medication leaflets and SPCs in 2010. This quantifies the risk for clinicians and patients to try to assist decision making and is an example of the product information developing as more becomes known about a medication over time.

Medical treatment of pregnant women will always produce challenging clinical judgements, and whether or not to take a medication during pregnancy is a complex decision. A body of literature has now been published discussing the benefits and risks of antidepressants treatment during pregnancy. It should be kep in mind that depression and anxiety in pregnancy are risk factors for adverse outcomes for both mothers and their newborn children. It is also now known that untreated depression can itself affect neonatal growth and has also been linked to e.g. miscarriage, preterm birth, and impaired foetal and postnatal development.
As we mentioned in my earlier email, it would also be most helpful if you would report your experiences. I have re-attached a consent form for you to sign and return to us. If you do not wish to do this directly to us, you could submit a yellow card report yourself directly now to the MHRA via their website; http://yellowcard.mhra.gov.uk/. If you do this, if you quote the Reference ADR 10748808, they will add this information to the original record that was reported in 2004.

Kind regards
Karen Warrillow
Medical Information Manager
Lundbeck Ltd, Lundbeck House
Caldecotte
Milton Keynes
BUCKS MK7 8LG
Tel: 01908 638972
Fax: 01908 372967

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Dec 12 - Cheryl to Lundbeck

Date: Thu, 12 Dec 2013 10:11:26 +0000
Subject: RE: Information relating to citalopram (Request ID 0005-8858, UK 8637)
From: REDACTED
To: UKInfo@Lundbeck.com
CC: REDACTED

Dear Lundbeck,

Thank you for taking the time to reply to the question I posed to yourselves. I do not, however, feel that any of them were clearly answered, in fact all of the information you stated I had already found for myself by researching online. I do understand that you cannot admit any facts that can be used to hold you responsible for my daughter's death but I did expect, considering the time you took to respond, that there may have been something which was new to me.

I have asked the MHRA under the freedom of information act for all correspondence between them and yourself in which my name is mentioned. I would like to ask if the MHRA have contacted you recently about my case I have submitted yet another yellow card.


In response to the following statement,

"When looking at the figures provided in the Drug Analysis Prints (DAPS) on the MHRA website, it is very important to be aware that the figures listed are not necessarily cases where the event is specified as being causally-related to the medicine in question, in this case citalopram. The MHRA state themselves in their guidance notes about DAPS; "The fact that a report has been submitted does not necessarily mean that the medicine has been proven to cause a reaction." The listings do not provide further information about the cases reported which also need to be taken into consideration, such as any medical conditions the patient might have or details on other medicines taken, or take into account the likelihood that all of the events listed are also reported in the general population. To put this information into context a little we know that worldwide more than 140 million patients have been treated with Lundbeck-manufactured citalopram over a 20-year period (and many more when generic preparations are included). This large volume of data includes cases of usage in pregnancy and through our frequent analysis and evaluation of this data reported to the company, and regularly forwarded to the drug regulatory authorities for their assessment, there is no evidence to indicate that usage of citalopram in pregnancy increases the risk for birth defects over the background risk. There are a number of reviews which have been published in the scientific literature which support this finding."

I would like to clarify your position, are you telling me that citalopram was not to blame for any of the cases referred to in the DAP?

I would also like to invite you to read a guest blog I wrote for Bob Fiddaman's blog? I will pop a link for you below. If you would like to reply on the blog please feel free to leave a message.

http://fiddaman.blogspot.co.uk/2013/12/citalopram-birth-defects-guest-post.html


I will be cc ing Mr Fiddaman in on all correspondence from now on. I hope that is not a problem.

Cheryl Buchanan

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Lundbeck have yet to reply.

I think it's important that we, as patients, query the drugs we are given when things go wrong. In Cheryl's case she lost a child. She has a right to question Lundbeck as they made the drug that Cheryl claims caused the birth defects.

It's also important to post emails publicly because other women who have taken citalopram and whose children were born with defects or whose pregnancies were terminated may just make that link and may also start to throw questions at Lundbeck.

Without mothers coming forward and reporting their adverse events to Lundbeck they can always turn a blind eye to something that has been staring them in the face for many years. Lundbeck, just like their rivals GlaxoSmithKline, have produced a drug that can cause birth defects. Instead of warning the public they choose to send meaningless emails to those whom question their drug. So be it. The more uncaring and meaningless emails they send, the more uncomfortable questions they will have thrown at them.

Cheryl is a tenacious woman. I think she is going to be around for a very long time. I think she is going to keep on asking Lundbeck those uncomfortable questions. I think she's right.

Bob Fiddaman


Speaking of emails...

I've been sitting on some Paxil ones for a few days. I'll release my findings soon.