A team of JAMA authors urged the FDA in 2014 to add “black box” warnings to dopamine agonists, linking the Parkinson's meds to pathological gambling, compulsive shopping and sexual obsessions. Now, consumer watchdog Public Citizen is upping the ante with a citizen petition to the agency, citing more than 80 studies supporting its claims.
Public Citizen’s petition calls for stronger warnings on six FDA-approved medicines including GlaxoSmithKline’s Requip, Boehringer Ingelheim’s Mirapex and UCB’s Neupro. Used to treat Parkinson’s disease and restless leg syndrome, the medicines can cause uncontrollable urges that in turn lead patients to divorce, financial ruin and suicide attempts, the nonprofit said.
And Public Citizen said the urges can occur with some frequency, citing data demonstrating that 17% of patients can experience the urges compared to 1% to 1.6% of the general population.
GSK disputes the assertions, with a spokesperson saying that the company “does not agree with the conclusions Public Citizen draws from the studies it has cited. The FDA-approved label, which is based on a review of the available data for Requip, clearly outlines the safety profile of the medicine which is very well known in the prescriber community."
Public Citizen has demanded safety warnings on a variety of drugs in the past, including the antifungal drug ketoconazle and Novo Nordisk's diabetes drug Victoza; the agency rejected both. The group also called on the FDA to ban the Alzheimer's drug Aricept for safety reasons. And Public Citizen hasn't limited itself to drug safety; it has questioned FDA marketing policies and accused the U.S. Justice Department for going soft on pharma investigations.
This time, the nonprofit is calling on the FDA to flag the potential side effects and is asking the FDA to require letters be sent to doctors and patients about the risks. The group documented some examples of the conditions, with one patient able to kick a vicious gambling addiction “within days of discontinuing pramipexole.”
In a brief statement, the FDA said it “will review the petition and respond directly to the petitioner.”
The medicines, which work by providing dopamine agonists to imitate dopamine in the brain, have caught headlines before for the unusual but potentially devastating side effects. Just last year, Pfizer settled a class-action suit with 172 patients who used Cabaser and Dostinex between 1996 and 2010. But the dopamine agonist class isn’t alone in its link to urges. Otsuka’s antipsychotic Abilify has a gambling urge risk on its label, and just last month the FDA added binge eating, excessive shopping and sex urges to the warning.
Boehringer Ingelheim declined issuing a statement and UCB didn't respond to a request for comment by press time.
- here's the release
- and the petition
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