Public Citizen Demands “Black Box” on Requip, Mirapex

June 30, 2016 — The consumer advocacy group Public Citizen is demanding a “Black Box” warnings on six medications about the risk of uncontrollable urges to gamble, eat, shop and have sex.

The petition called for stronger warnings on Apokyn, Requip, Mirapex, Neupro, Parlodel, Cycloset, and generic cabergoline.

These drugs belong to the dopamine-agonist class, and they are commonly used to treat Parkinson’s disease, restless leg syndrome, and other conditions. They influence the “reward” system in the brain, targeting chemicals involved in feelings of motivation and pleasure.

Public Citizen says studies have found that one in five patients taking these medications develops impulse-control problems or compulsive behaviors. There are reports of patients experiencing dramatic consequences — financial ruin, divorce, criminal records, and more.

The problem is that many people never realize that their medications are to blame. According to a Public Citizen researchers 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.”

In October 2014, a study published by JAMA Internal Medicine found over 1,500 reports of patients developing impulse-control disorders from dopamine agonists from 2003-2012.

Last month, the FDA issued a Safety Communication to announce that the label on Abilify and Aristada would be updated to include stronger warnings about “compulsive or uncontrollable urges to gamble, binge eat, shop, and have sex.”