FDA Warns Abilify Linked to Compulsive Urges - Drug Discovery and Development

The Food and Drug Administration issued a warning on Tuesday that reports of compulsive binge-eating, shopping, gambling, and sex have been connected to the antipsychotic Abilify.

Abilify (aripiprazole) treats a range of mental disorders like schizophrenia, bipolar disorder, Tourette syndrome, and even irritability associated with autism.

An examination of the FDA Adverse Event Reporting System (FAERS) database revealed that there were an estimated 184 cases of patients experiencing these urges, with 167 cases occurring in the United States.

Pathological gambling proved to be the most common side effect, with 164 cases. This adverse event is currently listed on the drug’s label, but the agency said the current warning didn’t adequately explain the risk it noted, reports The Wall Street Journal.

As a result of this information, the FDA is updating the warning label on Abilify and its generic counterparts.

The note emphasizes that these compulsive urges are rare, and they cease to happen when patients either stop taking the drug or the initial dosage is lowered.

Patients and caregivers should pay attention to any of these urges that may arise and should immediately consult a healthcare professional to limit or prevent harm. Physicians and medical professionals should alert patients of these side effects and closely monitor these individuals in the event these urges arise.

R&D 100 AWARD ENTRIES NOW OPEN:

Establish your company as a technology leader! For more than 50 years, the R&D 100 Awards have showcased new products of technological significance. You can join this exclusive community! Learn more.