GlaxoSmithKline (GSK), the original developer and maker of Paxil, transferred full responsibility for Paxil (paroxetine hcl) to Apotex in January 2014. At that time, Apotex began manufacturing Paxil and generic Paxil and assumed responsibility for the content of the Paxil/paroxetine label (the printed information that accompanies the drug).
Baum Hedlund Aristei & Goldman, a staunch prescription consumer drug safety advocate, wants Apotex to update the Paxil and paroxetine label to adequately warn about the risks of suicidal behavior beyond the age of 24.
Paxil and paroxetine’s current label fails to properly warn about the risks of adult suicidal behavior and in fact, states the opposite—that the suicidality risk does not extend beyond the age of 24.
Paxil/paroxetine, however, is associated with an increased risk of suicidal behavior in adults of all ages. In fact, there is a statistically significant 6.7 times greater risk in adults with Major Depressive Disorder (“MDD”) of all ages and the FDA’s 2006 analysis shows a statistically significant 2.7 times greater risk in adult patients across all indications (the symptoms for which the drug is meant to treat).
Just as GSK was brought to justice for failing to warn consumers about dangerous Paxil side effects in the Stewart Dolin generic Paxil suicide trial, so too should Paxil manufacturer Apotex be held accountable for any deaths linked to this drug and for not taking steps to correct the Paxil/paroxetine label to adequately warn about increased risk of suicidality for patients beyond the age of 24.
In April 2017, the Dolin paroxetine lawsuit returned a trial verdict of $3 million and sent a message to GSK and other drug manufacturers: you will be held accountable if you fail to warn consumers about dangerous side effects.
If you lost someone to suicide as a result of taking Paxil or Apotex generic Paxil (paroxetine), it is in your best interest to speak with an experienced Paxil attorney at Baum, Hedlund, Aristei & Goldman about your claim.
What is Apotex?
Apotex is Canada’s largest drug company and one of the largest generic drug manufacturers in the world. The Canadian pharmaceutical company manufactures more than 300 different pharmaceuticals, including Paxil.
Apotex and the Paxil / Paroxetine Warning Label
The content of the generic Paxil drug label when Mr. Dolin took the drug in 2010 was an important issue during the trial for his wrongful death. At that time, the paroxetine hcl label carried the same black-box warning that has been part of all antidepressant labels since 2007. It states that only children and young adults up to age 24 are at increased risk of suicide as a result of taking antidepressants.
Evidence handed over to the jury during the Dolin Trial and testimony regarding the issues surrounding the generic Paxil suicide case proved, and the jury agreed, that the increased risk of suicide also applies to adults beyond age 24. In fact, GSK’s 2006 internal analysis of its own suicide data confirms the increased risk.
To this day, the Paxil/paroxetine label still fails to warn adults over age 24 of the increased risk of suicide—a risk GSK is well aware of.
Apotex Should Change the Generic Paxil Label
The current Paxil/paroxetine label is scientifically, ethically and legally indefensible. The drug’s label does not warn physicians or consumers about the risk of suicide for adults over the age of 24. Instead, doctors and patients in their care are dangerously misled in two ways:
- They are led to believe the risk of suicide does not extend beyond age 24.
- They are led to believe known Paxil side effects are just symptoms of an alleged illness.
All of this puts patients and doctors in a very dangerous position.
The Paxil attorneys of Baum Hedlund sent a letter to Apotex on September 1, 2017, requesting that the company take “swift action” to “remedy the deficiencies in the Paxil label,” so that it warns of the increased risk of adult suicidal behavior related to taking Paxil and paroxetine. Failure to act would send a message that Apotex is willing to sacrifice public safety in pursuit of its own financial gain.
Baum Hedlund’s letter to Apotex: