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
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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
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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
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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
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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
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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
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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
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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
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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
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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.
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