Low-Dose Antipsychotics for Relapse Prevention

A recall has been issued by Ortho-McNeil-Janssen Pharmaceuticals for specific lots of 3-mg Risperdal (risperidone) tablets and 2-mg generic risperidone tablets because of an uncharacteristic musty odor thought to come from trace amounts of 2,4,6-tribromoanisole (TBA), the metabolite of a chemical fungicide used to treat wooden pallets on which the products are stored.1 McNeil Consumer Health has also recalled one lot of over-the-counter Tylenol Extra Strength caplets (225 count) for the same musty odor.2 TBA is not believed to be toxic, but it has been associated with transient GI symptoms. Several months ago, a similar recall was issued by OrthoMcNeil Neurologics for specific lots of topiramate (Topamax).3 1FDA MedWatch Alert: Risperdal (risperidone) and risperidone: recall – uncharacteristic odor. Available at www.fda.gov/Safety/MedWatch. 2FDA MedWatch Alert: Tylenol extra strength caplets, 225 count bottles: recall – uncharacteristic odor. Available at www.fda.gov/Safety/MedWatch. 3FDA MedWatch Alert: Topamax (topiramate): recall – musty odor. Available at www.fda.gov/Safety/MedWatch. See Psychiatry Drug Alerts 2011;25 (April):25.