Cautionary Advice for Off-Label Prescriptions

Fourteen years ago, one of the most important clinical studies of the 21st Century was released. Dubbed Study 329, it claimed to prove that the drug paroxetine (commonly sold by GlaxoSmithKline as Paxil) was safe to prescribe for individuals under the age of 18. Using this data, GlaxoSmithKline marketed the drug to physicians for what are called “off-label” prescriptions, prescribing a drug for a use or to an age group where safety and efficacy have not been proven.

It took only two years for regulators to step in and insist that the drug not be prescribed “off-label,” citing a sharp uptick in suicidal thoughts and actions by individuals in their teens and early twenties. GlaxoSmithKline was pursued on fraud charges, and ultimately accepted a 3 billion dollar fine in the United States.

Over the years, many incriminating statements by GlaxoSmithKline representatives have been made public, including acknowledgements by various company staff that the safety profile of paroxetine was not established. But now, Study 329 itself has drawn additional scrutiny. A reevaluation of the study by third-party experts has revealed Study 329:

• Intentionally overstated the efficacy of paroxetine for teens by five hundred percent; there was no actual clinical indication that paroxetine had a positive effect for teens suffering from depression
• Intentionally understated the danger, claiming five teenagers experienced suicidal ideation while being treated, when the number was much higher
• Was never retracted, despite the US Food and Drug Administration declaring it a failed trial less than a year later due to concerns with the protocols the study was conducted under

In the few short years GlaxoSmithKline pushed for paroxetine to be prescribed “off-label” to teens, thousands and thousands of young people suffered. Many people still bear the scars, both physical and mental, of the suicidal thoughts paroxetine created in their heads. That’s not counting the thousands of teens who killed themselves while under the effects of the drug.

Sadly, falsified data is still a major problem in the pharmaceuticals field, and many drug companies continue to push physicians to prescribe their drugs to people despite lacking clinical proof that those drugs will have a positive effect. Oftentimes the doctors who give in and make these recommendations are never held liable for their choices.

If you or someone you love has suffered due to medical malpractice, including the prescribing of dangerous medications, please contact a qualified attorney. Only when doctors and pharmaceutical companies are held to account for these acts will we see an end to dangerous “off-label” prescribing.