FDA Grants Petition for Amended Labeling of Dopamine Agonist Drugs

October 31, 2019

The FDA has granted part of a citizen petition calling for a safety warning on certain dopamine agonist drugs on the risks of impulse-control disorders (ICD)s for patients taking the drugs for restless legs syndrome (RLS).

The agency is requiring manufacturers of three products — Mirapex (pramipexole dihydrochloride), Requip (ropinirole hydrochloride) and Neupro (rotigotine) — to make changes to the products’ Warnings and Precautions sections, as well as the Patient Counseling Information sections, to state that patients taking the drugs for RLS may experience the disorders and “hallucinations/psychotic-like behavior.”

On its own initiative, the agency also notified manufacturers of Parlodel (bromocriptine mesylate), Dostinex (cabergoline) and Cycloset (bromocriptine mesylate) that new safety information regarding ICDs should be included in the labeling.

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