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FDA Petition Demands “Black Box” Warning on Requip, Mirapex

FDA Petition Demands “Black Box” Warning on Requip, Mirapex

June 30, 2016 — Public Citizen, a D.C.-based consumer advocacy group, has petitioned the FDA to place a “Black Box” warning about compulsive behaviors on the labels for six drugs.

The drugs include Apokyn, Requip, Mirapex, Neupro, Parlodel, Cycloset, and generic cabergoline. They belong to the dopamine-agonist class, like Abilify.

Last month, the FDA updated the label on Abilify to include stronger warnings about “compulsive or uncontrollable urges to gamble, binge eat, shop, and have sex.”

Public Citizen wants similar warnings on the label for other drugs in the same class. There are reports of patients experiencing life-altering consequences like divorce, financial ruin, and criminal records.

The problem is that many people do not realize that a drug they are taking for Parkinson’s disease or restless leg syndrome could be causing compulsive behaviors. According to a Public Citizen researcher who drafted the petition:

“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.”

Dozens of lawsuits have been filed by people who took Abilify and became addicted to gambling. In October 2014, JAMA Internal Medicine discovered over 1,500 reports of impulse-control disorders among patients on dopamine agonists from 2003-2012.

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