Public Citizen petitions for stronger warning labels on drugs that make patients lose control

Stronger warnings are needed on drugs that can cause patients to lose control of their behavior, leading to pathological gambling, hypersexuality, and compulsive shopping or eating, Public Citizen said in a petition to the US Food and Drug Administration.

The petition called for black box warnings on six dopamine agonist drugs (apomorphine, bromocriptine, cabergoline, pramipexole, ropinirole and rotigotine) that are used to treat Parkinson’s disease, restless leg syndrome (RLS) and several other conditions.

As studies have shown, as many as one in five patients taking a dopamine agonist drug may develop certain impulse-control problems and compulsive behaviors. In their more severe cases, impulse-control problems and compulsive behaviors can have devastating, life-altering effects. Divorces, financial ruin, criminal charges and suicide attempts have been reported in patients using these drugs. Without adequate warnings, these serious, drug-induced problems may not be reported to doctors, or may be misidentified and treated inappropriately with psychiatric medications or psychotherapy.

The petition describes many anonymous examples from the medical literature of patients whose lives were affected by these drugs. Two examples include: