US FDA raises safety concerns on aripiprazole-containing products

The US Food and Drug Administration (FDA) yesterday warned that compulsive or uncontrollable urges to gamble, binge eat, shop, and have sex have been reported with the use of the antipsychotic drug aripiprazole, namely Abilify and Abilify Maintena brands from Lundbeck (LUN: CO) and Otsuka (TYO: 4768)), Aristada from Alkermes (Nasdaq: ALKS), and generics).

Following the announcement, Alkermes’ shares fell 2.9% to $39.20 in after-hours US trading on Tuesday, though Denmark-based Lundbeck was virtually unchanged this morning.

These uncontrollable urges were reported to have stopped when the medicine was discontinued or the dose was reduced. These impulse-control problems are rare, but they may result in harm to the patient and others if not recognized.