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Pharmaceuticals / Regulatory Affairs

Public Citizen Sues FDA for Inaction on Boxed Warning Petition

May 7, 2019

Public Citizen is suing the FDA over its failure to act on a petition seeking a boxed warning on labels of dopamine promoters.

The consumer advocacy group’s 2016 petition called for black box warnings for six dopamine agonist drugs—apomorphine, bromocriptine, cabergoline, pramipexole, ropinirole and rotigotine—used for treating restless leg syndrome, Parkinson’s disease and other conditions.

Public Citizen said that the drugs could cause compulsive or uncontrollable behaviors in patients, urging the agency to issue letters to doctors and patients warning them about the risks.

“Patients taking a dopamine agonist drug may have up to a twenty-fold greater risk of impulse-control problems and compulsive behaviors, including pathological gambling and insatiable shopping or eating, than patients not using these medications,” the group said.

In a complaint filed April 29 in the U.S. District Court for the District of Columbia, the group calls for a decision on the petition, noting the FDA has failed to either grant or deny the petition filed more than two and a half years ago.

The FDA sent an acknowledgment letter in June 2016 and an interim response letter in December 2016 declaring that the issue was “not yet resolved,” but has taken no action since then despite the serious risks, the group said.

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