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