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Watchdog sues FDA for dragging its feet on Parkinson’s drug warnings


Public Citizen is demanding the FDA heed its 2016 petition calling for a black box warning on six dopamine agonists tied to compromised impulse control. (Pixabay)

Moving the FDA’s gears can be a lengthy process, particularly when it comes to citizen petitions. But after waiting two and a half years for regulators to stiffen impulse-control warnings on dopamine-driving Parkinson’s drugs, one watchdog group ran out of patience.

Public Citizen sued the agency Monday, demanding a D.C. district court force the FDA to add black box warnings to six dopamine agonists. The group cited reports of pathological gambling, compulsive eating and shopping and hypersexual behavior among patients using the drugs.

The lawsuit follows up on a 2016 citizen’s petition demanding warnings on GlaxoSmithKline’s Requip, Boehringer Ingelheim’s Mirapex and UCB’s Neupro and three other meds. Dopamine agonists are used to treat a variety of neurological conditions, including Parkinson’s disease and restless leg syndrome. A 2014 JAMA study linked the meds to compulsive behavior and problems with impulse control.

“Though more than two and a half years have passed since Public Citizen filed its petition, the FDA has neither granted nor denied the petition,” the suit stated. It urges the court to force FDA to act on the petition.

Citing data from more than 80 studies, Public Citizen said 17% of patients treated with dopamine agonists experience uncontrollable urges that can ruin their finances and destroy their personal lives. By contrast, only 1% to 1.6% of the general population suffers similar problem with impulse control, the group said.

In addition to boxed warnings—the FDA’s most serious—Public Citizen wants the agency to update doctors and patients with the latest data on those risks.

If Public Citizens’ bid for an injunction succeeds, it could claim another win at the agency after petitions calling out pelvic repair mesh devices and Takeda’s gout drug Uloric yielded FDA action.

In early April, the group applauded the FDA’s moratorium on pelvic mesh devices but said the agency had waited too long to heed the group’s citizen’s petition back in 2011. For Uloric, Public Citizen’s July 2018 petition to pull the drug off the U.S. market was followed by an FDA black-box warning earlier this year and new limits on its use in new patients.

Most recently, Public Citizen filed a petition calling for black box warnings on Amgen’s osteoporosis drug Prolia, citing data showing patients who stop treatment have a higher risk of severe spinal fractures.

The FDA has noted the fracture risks associated with stopping Prolia treatment and added warnings to its label, but hasn’t gone far enough to update physicians and patients, the watchdog said.