Black Box Warning
Weiss doesn’t believe that improved screening techniques and monitoring is enough.
“I don’t think DAs are that helpful for PD,” he says. “They were overutilized in the 1990s, when the prevalent protocol was to delay levodopa. But these days, there is no compelling reason to prescribe them. I think they should have a black box warning — it’s one ways of getting a doctor’s attention.” (A black box warning is the strictest warning put in the labeling of prescription drugs or drug products by the Food and Drug Administration () when there is reasonable evidence of an association of a serious hazard with the drug.)
“The benefits of dopamine agonists are overestimated, and the risk is underestimated,” he adds.
Study authors not only called for a black box warning, but also “urged doctors to vigilantly monitor people taking these medications and to counsel them and their families about the risk of serious impulse disorders.” The study authors noted “that people at higher risk for impulse control disorders should not take dopamine agonists — including people with a history of such disorders or a personal or family history of obsessive-compulsive disorder, bipolar disorder, impulsive personality, alcoholism, drug abuse, or other addictive behaviors.”
As the risks become clearer, both patients and doctors are becoming better informed about how to ensure safety. Patients need to educate themselves about DA side effects, involve family members and friends in monitoring their behavior for possible ICDs, and inform their physicians if they experience ICDs or DAWS. As for the clinicians who use DAs, the imperative is clear: Avoid prescribing high doses of DAs, closely monitor DA-treated patients for signs of ICDs, and finally, warn patients of the risks of withdrawal before they start using it.