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Petition to the FDA to Require a Black-Box Warning for Dopamine Agonist Drugs

View as PDF.

View press release.

Public Citizen petitions the Food and Drug Administration (FDA) to add stronger warnings to the labeling for dopamine agonist drugs (apomorphine, bromocriptine, cabergoline, pramipexole, ropinirole, and rotigotine) to alert doctors and patients to the risk of impulse-control problems and compulsive behaviors, including pathological gambling, hypersexuality, and compulsive shopping and eating.

June 30, 2016, Acknowledgement letter from the FDA.

December 20, 2016, Interim response letter from the FDA.

View Public Citizen’s April 29, 2019, lawsuit complaint against the FDA.

October 21, 2019, FDA final response letter.