The drug Risperdal, by Ortho-McNeil-Janssen Pharmaceuticals, has been recalled due to consumer reports of an uncharacteristic odor. The drug was found to be contaminated with 2,4,6 tribromoanisole (TBA), a chemical preservative added to wooden pellets that the product is packaged with during transit. Although TBA is not considered toxic, some consumers have developed gastrointestinal symptoms afterward.
The affected products are 16,000 bottles of Risperdal, lot number 0GG904 with an expiration date of May 2012 and Risperidone tablets, lot number 0LG175 with an expiration date of August 2012.
The drug is used as a treatment for bi-polar depression and schizophrenia and also to mask symptoms of irritability in autistic children.
Side-Effects of Risperdal
Common side effects include drowsiness, sedation, fatigue, tremor, insomnia, stiff muscles, stuffy nose, runny nose, dry mouth, coughing, vomiting, constipation, nausea, abdominal pain, drooling, dizziness, anxiety, headaches, nasal congestion, restlessness, rashes and the common cold. These side effects occur in at least 10 in every 100 people who take Risperdal.
It also has more serious side effects including the onset of diabetes mellitus, in some cases severe and resulting in coma and death, hypotension (low blood pressure), leukopenia, neutropenia, aspiration pneumonia, motor impairment, seizures, priapism (an erection lasting four or more hours), thrombotic thrombocytopenic purpura (TTP), disruption of body temperature regulation, neuroleptic malignant syndrome (a severe and potentially fatal reaction to drugs), and permanent tardive dyskinesia (involuntary movements). Elderly people may develop strokes after taking Risperdal and they have an increased risk of death so they should not take the drug.
Any patient with the affected lot numbers should return their medication to their pharmacist.
For more information, contact the Medical Information Recall Line on 800-634-8977.
Any adverse reactions can be reported to the U.S. Food and Drug Administration online at:
www.fda.gov/medwatch/report.htm
Sources:
FDA Press Release, 17th June 2011 - http://www.fda.gov/Safety/Recalls/ucm259820.htm
Risperdal Data Sheet - http://www.risperdal.com/sites/default/files/shared/pi/risperdal.pdf
Reviewed June 22, 2011
Edited by Alison Stanton