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Experts Say Parkinson’s Drugs May Need “Black Box” Warnings


October 21, 2014 — Researchers are calling for a “Black Box” warning label about pathological gambling, hyper-sexuality, compulsive shopping, and other impulse disorders on the label for drugs in the dopamine agonist class, which are commonly used to treat Parkinson’s disease and restless-leg syndrome.

The study, published in JAMA Internal Medicine, found a 277% increased risk of impulse-control disorders associated with dopamine agonists.

Requip (ripinirole) and Mirapex (pramipexole) were associated with the highest risk. A signal was also seen in patients on Abilify (aripiprazole), an anti-psychotic medication that also targets the dopamine D3 receptor.

The study suggests that 1 in 7 patients on the drugs develop psychological side effects. However, this might be a low estimate because some patients might be too embarrassed to tell their doctor about the side effect. They also may not realize the impulse disorders are a potential side effect.

According to the Wall Street Journal, researchers believe “the likelihood of a causal connection is high” and stronger warnings are needed:

“At present, none of the dopamine receptor agonist drugs approved by the FDA have boxed warnings as part of their prescribing information. Our data, and data from prior studies, show the need for more prominent warnings.”

Labels on the most popular dopamine agonists already contain warning about impulse disorders. Experts have known about the side effect for over a decade. Stronger warnings might make doctors reconsider the risks and benefits of prescribing the drugs for mild disorders, such as restless leg syndrome or hyperprolactinemia (abnormal production of milk).


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