Public Citizen Calls on FDA to Add Boxed Warning to Dopamine Agonist Drugs

Public Citizen is calling on the FDA to add a boxed warning to a class of drugs for treating Parkinson’s disease and ADHD to address a potential link to behavioral problems.

The consumer advocacy group filed a citizen petition citing a host of studies linking dopamine agonist drugs to problems with compulsive behavior and impulse control. These can include pathological gambling, hypersexuality, compulsive shopping, spending, buying and eating.

Public Citizen’s petition also pushed the agency to establish REMS for these conditions that would entail alerting physicians to the dangers and detailing the risk to patients in medicine guides that accompany all new prescriptions and refills on dopamine agonists.