Apotex Generic Paxil Warning Label 2018-07-09T13:37:48+00:00

Apotex Generic Paxil Warning Label

Apotex Generic Paxil

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).

apotex black box warning

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:

  1. They are led to believe the risk of suicide does not extend beyond age 24.
  2. 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.

generic paxil

Baum Hedlund’s letter to Apotex:

Dr. Jeremy Desai
Mr. Bernard Sherman
Mr. Jack M. Kay
Apotex, Inc. 150 Signet Dr., North York,
ON M9L 1T9, Canada

Re: Paxil and Suicide

Dear Messrs. Desai, Sherman, and Kay:

I am writing to Apotex as the exclusive holder of the New Drug Application for Paxil. As of January 2014, Apotex became exclusively responsible for the content and accuracy of the Paxil and paroxetine label, charged with ensuring the label remains up-to-date and adequate at all times.

This letter officially places you on notice that the label for Paxil does not adequately warn about the risks of adult suicidal behavior and that it needs to be corrected. It is my hope that Apotex will take swift action to protect the health and safety of patients taking Paxil/paroxetine.

On April 20, 2017, a federal jury entered a verdict against GlaxoSmithKline, Inc. (“GSK”), and in favor of a widow of a Chicago man who killed himself six days after starting a generic version of Paxil. As part of that verdict, the jury concluded that the Paxil label, as it has existed since 2007, is inadequate because it fails to properly warn about the risks of adult suicidal behavior causally related to ingestion of Paxil/paroxetine. Specifically, the paroxetine label did not warn of the drug’s association with an increased risk of suicidal behavior in adults despite GSK’s knowledge of a statistically significant 6.7 times greater risk in adults with Major Depressive Disorder (“MDD”) of all ages and the FDA’s 2006 analysis of a statistically significant 2.7 times greater risk in adult patients across all indications. Indeed, since 2007, the Paxil label has not only failed to warn about this increased risk, it has stated the opposite—that the suicidality risk did not extend beyond the age of 24. This verdict was rendered after more than five weeks of testimony and evidence that focused on the extensive clinical, scientific and medical evidence pertaining to paroxetine.

Please review these transcripts and documents. They reveal a serious problem, one that Apotex is in a unique position to remedy.

This is your opportunity to do the right thing and remedy the deficiencies in the Paxil label. Failure to take action would mean your company is deliberately refusing to correct a known and quantifiable risk. Any suicides or attempted suicides that could have been prevented by a label change are now on you. We urge Apotex to take swift action to protect the public health.

Best,
BAUM HEDLUND ARISTEI & GOLDMAN, P.C.

Brent Wisner
Michael L. Baum
Pedram Esfandiary

How Can I File an Apotex Generic Paxil Lawsuit?

If you or someone you care about attempted or committed suicide while taking Apotex Paxil or Apotex generic Paxil, we can help. The law firm of Baum, Hedlund, Aristei & Goldman has extensive experience bringing major pharmaceutical companies to justice.

To learn more about filing a Paxil suicide lawsuit, contact the law firm of Baum, Hedlund, Aristei & Goldman today for a free case evaluation.

Our law firm has represented thousands of Paxil victims from across the United States for a variety of injuries, including suicide. If you would like to speak with a Paxil lawyer about filing a claim, please contact us by filling out the contact form, or by calling toll free 1-800-827-0087.