Advocacy Group Sues FDA Over Dopamine Warnings

The US market watchdog Public Citizen has sued the Food and Drug Administration (FDA), demanding that a district court in Washington, DC, require the agency to add “black box” warnings to six dopamine agonists produced in the US.

Public Citizen said use of the drugs prescribed to treat a variety of neurological conditions, including Parkinson’s disease has evidently led patients to engage in “pathological gambling, compulsive eating and shopping and hypersexual behavior.”

The lawsuit comes more than two years after the group’s 2016 petition demanding that warning labels be placed on dopamine drugs produced by GlaxoSmithKline’s Requip, Boehringer Ingelheim’s Mirapex and UCB’s Neupro, along with three other medications. A 2014 JAMA study linked them to the compulsive behavior and impulse control problems.

This is not the first time Public Citizen has taken on the FDA. In the past, reports point to several successes. Its petitions calling out pelvic repair mesh devices and Takeda’s gout drug Uloric for action previously set the agency’s wheels in motion.

Earlier this month, US pharma journals reported that Public Citizen filed a petition calling for black box warnings on Amgen’s osteoporosis drug Prolia. The advocacy group citing data showing that patients who stop treatment have a higher risk of severe spinal fractures.

The petition said the FDA had acknowledged the fracture risk, but had not gone far enough to update physicians and patients.