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# Add Boxed Warning to Dopamine Agonists: Advocates
- URL: https://www.fdaweb.com/add-boxed-warning-to-dopamine-agonists-advocates/
- Published: 2016-06-29T12:00:00.000Z
- Updated: 2026-09-14T21:12:22.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5136078

The health advocacy organization Public Citizen has [petitioned](http://www.citizen.org/pressroom/pressroomredirect.cfm?ID=7940&ref=fdaweb.com) FDA to add a Boxed Warning to labeling for six dopamine agonists used in treating Parkinson’s disease and restless leg syndrome for an increased risk of impulse control problems that can lead to pathological gambling, hypersexuality, and compulsive shopping or eating. The drugs cited in the petition are US Worldmeds’ Apokyn (apomorphine), Veroscience’s Cycloset (bromocriptine), Par’s Cabergoline (cabergoline), Boehringer Ingelheim’s Mirapex (pramipexole), GlaxoSmithKline’s Requip (ropinirole), and UCB’s Neupro (rotigotine).

The petition says that studies have shown that as many as 20% of patients taking a dopamine agonist may develop certain impulse control problems and compulsive behaviors. It describes many anonymous examples from the medical literature of patients whose lives were affected by the drugs.

Researchers from Public Citizen said that patients “must be warned to watch for these symptoms and talk to their doctors early, before the drugs cause serious harm to their lives and social relationships. Strong warnings given directly to patients and doctors are especially important here, because many of the people who find themselves engaging in these embarrassing behaviors will not report them or connect them to the drug.”

The petition also asks the agency to require that letters be sent to patients and doctors to inform them of the potential risks.