In a Safety Warning posted yesterday, the FDA said patients may experience uncontrollable urges after taking aripiprazole, the active ingredient in Abilify and Aristada.
The agency said the behaviors stopped after users went off the medication, suggesting a close relationship.
The labels already include warnings about gambling addiction. The FDA will expand warnings to include excessive spending, shopping, binge eating, and sexuality.
The FDA approved Abilify in November 2002. In the last 13 years, the agency received 184 reports of patients who experienced impulse-control problems worldwide. Of those, over 90% involved gambling.
To put the risk in context, approximately 1.6 million patients received a prescription for Abilify or Aristada in the United States in 2015.
The drugs treat mental illness by blocking dopamine and balancing serotonin. These chemicals are released in the brain during pleasurable activities, activating the “reward system” and reinforcing the behavior.
The first evidence linking dopamine-blockers and gambling addiction dates back to 2005, when researchers at the Mayo Clinic presented 11 case reports. One 52 year-old man lost $100,000 in casinos after previously betting only once in his life.
In 2011, an even more frightening case report was linked to Abilify:
[J] was pre-occupied with thoughts of gambling and his gambling activity became both impulsive and involved extensive planning in obtaining funds to gamble, including the use of crime.”
In another report, “[S] began experiencing strong urges to gamble in the form of a euphoric feeling when thinking about gambling. In the following 2 years he incurred debts of around £25 000 on internet betting sites.”