FDA Urged to Add Black Box Warnings to Dopamine Meds

FDA-Urged-to-Add-Black-Box-Warnings-to-Dopamine-Meds-e1472500878210The U.S. Food and Drug Administration (FDA) has been urged by the public nonprofit watchdog group Public Citizen to add black box warnings to dopamine medication, saying that it can cause compulsive behaviors in users.

The Public Citizen petition sent to the FDA Commissioner in June 2016 said that dopamine agonists have been shown to cause compulsive behaviors such as gambling, shopping and sexual obsession in people who use them to treat restless leg syndrome and Parkinson’s Disease. The drugs listed in the petition include Requip, Mirapex and Neupro as well as three other drugs.

The petition lists 80 studies that link the use of dopamine agonists to compulsive behaviors, and says that 17 percent of people who use the drugs suffer from this adverse reaction, which has been attributed to the way the drugs affect the levels of dopamine in the brain.

A number of lawsuits have been filed by users of these drugs who say they caused a lack of impulse control that led to compulsive behaviors, especially gambling. In 2010, a jury awarded $8.3 million to a man who sued Boehringer Ingelheim, alleging the company’s Mirapex medication caused him to lose more than $260,000 due to compulsive gambling.

Abilify is another partial dopamine agonist that has been shown in studies to make users at a higher risk for compulsive behavior. The FDA issued a safety warning in May 2016 that Abilify, Abilify Maintena, Aristata and their generic equivalents could cause uncontrollable urges to binge eat, shop, gamble and have sex. These drugs are typically prescribed to treat a variety of mental disorders.

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