Janssen Pharmaceuticals, a unit of Johnson & Johnson, has announced the recall of a lot its injectible schizophrenia drug Risperdal Consta.
Mold was discovered in vials of Consta during routine testing. Consta, a long-acting form of Risperdal (risperidone), is prescribed to treat bipolar disorder and schizophrenia, Reuters reports. Risperdal Consta is injected, unlike basic Risperdal, which is in pill form. Contaminated injectible drugs put patients at risk for infection.
A single lot of Risperdal Consta consists of about 70,000 dosage packs. Company spokeswoman Robyn Reed Frenze estimates that “fewer than 5,000 dose packs remain in the market,” according to an email to Reuters. Frenze said the risk to patients is considered low, and “there have been no trends of adverse events of infection associated with this lot.” Risperdal Consta must be administered by a healthcare professional. The company advises patients to consult their doctors but to continue prescribed treatment.
Johnson & Johnson subsidiaries have recalled a variety of products in the last two years, including over-the-counter drugs, contact lenses, heart devices, and insulin pump cartridges, Reuters reports. Earlier this year Johnson & Johnson reached a settlement with the U.S. Department of Justice over improper marketing of Risperdal for unapproved uses in children and adolescents. Of particular concern is that Risperdal causes breast growth (gynecomastia) in boys 10 and older who take the drug. Some young men have needed to undergo mastectomy to remove the female breasts they developed.
Risperdal use in nursing homes has also come under scrutiny, as the federal government has made efforts to reduce inappropriate use of antipsychotic drugs to control restlessness and agitation in elderly patients. Studies have shown that these drugs increase the risk of death in elderly dementia patients, the Wall Street Journal reports.