UPDATE: FDA WARNING ON ABILIFY

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IMPULSE CONTROL FINDINGS WITH ABILIFY

By Lirio Sobrevinas-Covey, Ph.D.

In a recent post on AAAP (May 1, 2016), I had cited research findings indicating the efficacy of risperidone (Risperdal) and aripirazole (Abilify) for reducing irritability and aggression in children and adolescents with autism (Fung LK et al, 2016). This conclusion was based on findings from 46 randomized clinical trials involving these drugs and other anti-psychotic medications showing significantly greater symptom improvement among those who received the drug than those who received the placebo (Fung LK, 2016). Only Risperdal and Ability have been approved by the FDA.

My post included the cautionary statement from the meta-analysis that – “Both risperidone and aripiprazole when compared with placebo showed higher rates of sedation, somonolence, weight gain, and extrapyramidal symptoms.”

Further adverse effects of Ability, although rare and not specifically cited in the meta-analysis, have resulted in warnings from the FDA regarding impulse control problems associated with the drug.

“The FDA has become aware of other compulsive behaviors associated with aripiprazole, such as compulsive eating, shopping, and sexual actions. These compulsive behaviors can affect anyone who is taking the medicine. As a result, FDA is adding new warning about all of these compulsive behaviors to the drug labels and the patient Medication Guidelines for all aripiprazole products.”

The FDA recommends that clinicians make their patients and caregivers aware of these impulse control risks, and that they should specifically ask patients about the emergence of new or increased urges while they are using Abilify. As also suggested in my May 1 post in AAAP Today, the FDA advises clinicians to consider reducing the dose or stopping the medication if such urges develop. Patients should not make these changes without consulting their prescribing physician.

Reference: Catherine Cassels, Psychiatry and Mental Health, May 3, 2016.