October 21, 2014 — JAMA Internal Medicine has published a study linking severe impulse control disorders to the use of prescription drugs commonly used to treat Parkinson’s disease and restless-leg syndrome, leading researchers to call for a “Black Box” warning about the side effects.

Conclusions were based on adverse event reports submitted to the FDA for six drugs in the dopamine receptor agonist class. The drug class was linked to a 277% increased risk of impulse-control disorders.

The highest risk was associated with Requip (ripinirole) and Mirapex (pramipexole). They also found a statistically-significant risk associated with Abilify (aripiprazole), an anti-psychotic medication.

The study suggests that 1 in 7 patients who take dopamine agonists experience psychological side effects. However, this may be a low estimate of the risk if patients are too embarrassed to admit the effect. Patients may not realize impulsive behavior is a side effect.

Experts have known for over 10 years that dopamine agonists may lead to gambling addiction, hyper-sexuality, compulsive shopping, eating disorders, and stealing. GlaxoSmithKline, the manufacturer of Requip, warns about “problems with impulse control or compulsive behaviors” in the Prescribing Information.

Researchers say these warnings are not strong enough. They say “the likelihood of a causal connection is high” and they want the FDA to place stronger warnings on the label, according to the Wall Street Journal.

A stronger warning could lead doctors to reconsider the risks and benefits of prescribing drugs for non-serious conditions, like mild restless leg syndrome or hyperprolactinemia (hormonal disorder causing lactation).


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