FDA Issues Warning for Aripiprazole Users
May 3, 2016 – The U.S. Food and Drug Administration (FDA) is cautioning users of aripiprazole which may rarely be associated with uncontrollable behaviors. Available as generics and with the brand names Abilify® and Aristada™ (aripiprazole lauroxil), aripiprazole is an antipsychotic medication used to treat a number of psychological conditions including autistic irritability, bipolar disorder, schizophrenia and Tourette’s syndrome. It also may be used with other drugs to treat depression. The FDA has identified compulsions that also could result from taking aripiprazole, such as overpowering cravings to eat, shop or engage in sexual activity, in addition to feeling compelled to gamble which is already is listed as an uncommon side effect on its labeling. Most of the affected patients did not exhibit compulsive tendencies before starting treatment and by decreasing or stopping aripiprazole the compulsions were eliminated, as well. The FDA will require manufacturers to include a warning about the possibility of these additional compulsions on the labeling and in the patient Medication Guides for all aripiprazole products. Prescribers, patients and caregivers should be alert for uncharacteristic compulsive behaviors.
Adverse reactions or quality problems experienced with the use of a recalled product may be reported to the FDA’s MedWatch Adverse Event Reporting Program either online, by regular mail or by fax.
- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
Actual drug patent expiration dates and a availability of new medications are subject to change due to patent litigation, settlement agreements, additional patents, exclusivities, and final FDA approval. Distribution and availability of new medications at pharmacies may not occur immediately following FDA approval. Patients are advised to speak with their healthcare professional or pharmacist regarding appropriateness as well as actual availability.
*This is provided for information only. The reference to any medication above does not mean the medication is covered by your plan.