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On April 29, 2019, Public Citizen sued the Food and Drug Administration (FDA) for failing to act on our June 2016 petition seeking stronger warnings about the risk of compulsive or uncontrollable behaviors in the product labeling for a class of drugs known as dopamine agonists.[1]
In its 2016 petition, Public Citizen called for black-box warnings on six dopamine agonist medications that, depending on the drug, are used to treat Parkinson’s disease, restless legs syndrome and several...
On April 29, 2019, Public Citizen sued the Food and Drug Administration (FDA) for failing to act on our June 2016 petition seeking stronger warnings about the risk of compulsive or uncontrollable behaviors in the product labeling for a class of drugs known as dopamine agonists.[1]
In its 2016 petition, Public Citizen called for black-box warnings on six dopamine agonist medications that, depending on the drug, are used to treat Parkinson’s disease, restless legs syndrome and several other conditions: apomorphine (APOKYN), bromocriptine (CYCLOSET, PARLODEL), cabergoline (generic only), pramipexole (MIRAPEX), ropinirole (REQUIP) and rotigotine (NEUPRO).[2]
The petition presented a large body of evidence showing that dopamine agonist drugs frequently can cause impulse-control problems and compulsive behaviors, including pathological gambling, hypersexuality and insatiable shopping or eating. Studies have shown that as many as one in five patients taking a dopamine agonist drug may experience such adverse effects. In the most 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. In one case, a patient treated with pramipexole for restless legs syndrome attempted suicide because of distress from uncontrollable gambling. After his dose was increased, he developed overwhelming urges to buy lottery scratch cards, spending up to $700 a day on his new habit, and ultimately spending at least $120,000. His gambling stopped within days of discontinuing pramipexole.
Often, patients taking dopamine agonists who experience impulse-control problems and compulsive behaviors and their families are unaware that these behaviors are caused by the drugs or even that the behavior is abnormal. One patient who lost roughly $70,000 gambling over three years while taking the drug later told doctors, “They should have forewarned me that this medication could turn me into a gambler. Then things would not have got as bad as they did.”
The current warnings found in the product labels of the dopamine agonists are far too obscure, weak and inconsistent, failing to adequately warn doctors and patients about these serious risks. When Public Citizen filed its lawsuit in the U.S. District Court for the District of Columbia, nearly three years had passed since our petition was submitted to the agency. The agency’s reckless delay in the face of overwhelming evidence supporting our petition has endangered countless patients. The FDA needs to act now before these adverse effects devastate more patients’ lives.
References
[1] Public Citizen. FDA must act on drugs that cause compulsive gambling, insatiable binging, Public Citizen lawsuit says. April 29, 2019. https://www.citizen.org/news/fda-must-act-on-drugs-that-cause-compulsive-gambling-insatiable-binging-public-citizen-lawsuit-says/. Accessed June 28, 2019.
[2] Public Citizen. Petition to the Food and Drug Administration regarding dopamine agonist drugs. June 29, 2016. https://www.citizen.org/wp-content/uploads/migration/2328.pdf. Accessed June 28, 2019.
