Public Citizen Files Lawsuit To Get FDA to Add Impulse Control Warning Added To Requip, Similar Parkinson’s Disease Drugs

A prominent consumer watchdog group is asking a court to force federal regulators to act on a petition that calls for stronger label warnings about the risk of gambling, sex addiction and other impulsive behaviors that may result from side effects of Requip and other similar Parkinson’s disease drugs.

Public Citizen filed a complaint (PDF) in the U.S. District Court for the District of Columbia last week, naming the U.S. Food and Drug Administration (FDA) as the defendant.

The lawsuit indicates that the agency has failed to act on a petition filed in June 2016, which called for the agency to require boxed warnings on a class of drugs known as dopamine agonist medications, including Apokyn, Requip, Mirapex, Neupro, Parlodel, Cycloset, and generic cabergoline.

The warnings are the strongest the FDA can require a drug to carry, providing risk information in a prominently placed black box on the label. The group indicate that consumers and doctors should be warned about the importance of being on the look out for compulsive behaviors that may be caused by the drugs, which are commonly prescribed to treat symptoms of Parkinson’s disease, restless leg syndrome and a number of other conditions.

However, it’s been three years since the petition was filed and the FDA has failed to act, Public Citizen officials say.

“There is clear evidence that links dopamine agonist medications to certain impulse-control problems and compulsive behaviors,” Dr. Michael Carome, director of Public Citizen’s Health Research Group, said in a press release. “The current warnings found in the product labels are far too obscure and weak and do not adequately warn prescribers and patients about these serious risks. The FDA needs to act now before these adverse effects devastate more patients’ lives.”

The lawsuit calls for declaratory and injunctive relief, indicating the FDA has failed to follow rules requiring a response to such a petition, whether to act on the call to action or give a reason why it chooses to reject the petition.

The impulse control warnings have been most frequently linked to Abilify, which belongs to the same class of medications, but is an antipsychotic and not a Parkinson’s disease treatment.

There are currently more than 2,000 Abilify lawsuits pending in the federal court system against Bristol-Myers Squibb and Otsuka Pharmaceuticals, each raising similar allegations that the drug makers failed to adequately warn users and the medical community about the side effects of Abilify, which may cause users to experience sudden and uncontrollable urges to gamble or engage in other impulsive behaviors.

Plaintiffs each maintain that they could have avoided devastating financial losses and damage to their families if information had been provided about the link between Abilify and gambling addictions, which lawsuits typically indicate emerged shortly after starting use of the drug or changing dosage.

A global settlement resolving most of the Abilify complaints is pending in the federal court system.