Zantac Lawsuit


Researching drug company and regulatory malfeasance for over 16 years
Humanist, humorist

Monday, July 17, 2017

Paxil/Zoloft Homicide - "Unlabelled Potential Side Effects"





Last year I wrote about Andrew Thibault who, just like me, has been at loggerheads with the those who oversee the safety and efficacy of drugs on the market. Thibault has successfully obtained many documents off the FDA, which he has made public at murdermeds.com.

Earlier today a series of tweets peaked my interest. Pharmabuse is a Twitter account that has the tagline, 'Parents Against Pharmaceutical Abuse (PAPA)', and their website, pharmabuse.com is a minefield of information.

Rather brilliantly, Thibault has filed a lawsuit against the FDA because, well, because they don't seem to be playing ball with requests he made to them under the Freedom of Information Act. (Sound familiar?)

Thibault's series of FOIA's involved questions relating to documents that the FDA had in their possession regarding psychiatric medication and homicide, moreover whether or not there was a link to the two.

A 25 page document highlights the FDA's obvious stonewalling of Thibault, a game that drug regulators like to play with anyone who asks for records that may show them in a bad light. The document is a fascinating read and I urge you all to read and share it, if only to see the outcome :-)

So, what has the title of my blog post got to do with the MHRA?

Well, earlier today Thibault made another document publicly available, a document which he obtained under the FOIA from the FDA. It involves two antidepressants, namely setraline (Zoloft) and paroxetine (Paxil/Seroxat). The document is AERS Case Number 6330848 and is just 4 pages in length. It's an adverse event report from an unknown person (it's been redacted) who experienced the following side effects whilst taking both paroxetine and sertraline...

Agitation
Depression
Homicide
Restlessness
Suicidal ideation
Suicide attempt
Tension

As you will note, there is one adverse event in the list that sticks out like a sore thumb: Homicide.

The causality assessment regarding homicide reads "possible."

When carrying out an assessment of the adverse reaction report the MHRA , according to the tweet I recieved earlier, had this to say about both drugs. Pay particular attention to the last paragraph.



CLICK IMAGE TO ENLARGE



I'm not quite sure what "unlabelled potential side effects" means? According to Pfizer  an unlabelled side effect is an unexpected adverse event. Begs the question, how many more have they had?

It's interesting, to me at least, that the MHRA have thrown in the word 'potential' which, in essence, means possible, likely, or probable.

It's quite bizarre that, in its assessment, the MHRA can state quite clearly that agitation
depression, restlessness, suicidal ideation and a suicide attempt were assessed and rated as possibly related to paroxetine use yet, despite this, they claim there is insufficient evidence to assess the causality regarding the homicide, opting instead to label it as an "unlabelled potential side effect." They do pretty much the same in their assessment of sertraline.

When you read this four page adverse event in conjunction with the 25-page court document filed by Thibault all, it seems, becomes crystal clear. In filing his lawsuit Thibault claims that the FDA told him in a telephone conversation the subject matter he had requested "did not make for fun reading", adding that he (Thibault) "should take into account "psychiatric diagnoses of the patients."

It's almost as if they have resigned themselves to the fact that the information is explosive yet, on the same hand, they are guiding Thibault away from the medication causing the adverse events and leading him toward their blame the patient mantra which they have spewed for many years.

Both the FDA and the MHRA maintain that SSRIs do not cause a person to carry out a homicidal act. This despite a large number of high profile cases that implicate many SSRIs. I covered many of Thibault's FOIA documents last year that, to me at least, show a very worrying link. Back stories at the foot of this post.

For years they have covered up the withdrawal problems patients face when taking these drugs, they have covered up the suicide links regarding these drugs. Safe to assume then they are sitting on more information regarding the homicide link with these drugs. But hey ho, I'm just a smeary conspiracy theorist.

The full 4-page document is now available here.

Thibault's lawsuit against the FDA can be accessed here.

Well done Mr. Thibault. I salute you, sir.

On Wednesday July 26, 2017 Panorama will air in the UK in an hour long special and will reveal the devastating side effects that can lead to psychosis, violence, possibly even murder.

The BBC website reads...

With exclusive access to psychiatric reports, court footage and drug company data, reporter Shelley Jofre investigates the mass killings at the 2012 midnight premiere of a Batman movie in Aurora, Colorado. 24-year-old PhD student James Holmes, who had no record of violence or gun ownership, murdered 12 and injured 70. Did the SSRI anti-depressant he had been prescribed play a part in the killings?
Panorama has uncovered other cases of murder and extreme violence which could be linked to psychosis developed after the taking of SSRIs- including a father who strangled his 11-year-old son.
Panorama asks if enough is known about this rare side effect, and if doctors are unwittingly prescribing what could be a prescription for murder.

I, for one, will be watching it.

Bob Fiddaman



Previously in the Homicide Files series.







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