Johnson & Johnson is voluntarily recalling one lot of schizophrenia drug Risperdal Consta after discovering mold during a routine testing process, a company spokeswoman said, the latest in a string of recalls over the past two years.
Risperdal Consta is manufactured by Janssen Pharmaceuticals, a unit of Johnson & Johnson. The company is recalling the drug from wholesalers, distributors, pharmacies and healthcare providers.
The medicine is a long-acting form of J&J’s Risperdal anti-psychotic medication, and is used to treat bipolar disorder and schizophrenia. It is injected, unlike basic Risperdal, which is a pill.
“We estimate that fewer than 5,000 dose packs remain in the market considering our current inventory levels and the usage of this product,” spokeswoman Robyn Reed Frenze said in an email to Reuters. A single lot of Risperdal Consta consists about 70,000 dosage packs.
Frenze said that the risk to patients is considered low, and “there have been no trends of adverse events of infection associated with this lot”.
The spokeswoman added that the medication is administered to patients by healthcare professionals only, “and it is important that patients continue their prescribed treatment”.
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In the past two years J&J has recalled over-the-counter drugs, contact lenses, heart devices, and insulin pump cartridges.
RISPERDAL® CONSTA® - (risperidone)
INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIARELATED PSYCHOSIS
Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Analyses of 17 placebo-controlled trials (modal duration of 10 weeks), largely in patients taking atypical antipsychotic drugs, revealed a risk of death in drug-treated patients of between 1.6 to 1.7 times the risk of death in placebo-treated patients. Over the course of a typical 10-week controlled trial, the rate of death in drug-treated patients was about 4.5%, compared to a rate of about 2.6% in the placebo group. Although the causes of death were varied, most of the deaths appeared to be either cardiovascular (e.g., heart failure, sudden death) or infectious (e.g., pneumonia) in nature. Observational studies suggest that, similar to atypical antipsychotic drugs, treatment with conventional antipsychotic drugs may increase mortality. The extent to which the findings of increased mortality in observational studies may be attributed to the antipsychotic drug as opposed to some characteristic(s) of the patients is not clear. RISPERDAL® CONSTA® (risperidone) is not approved for the treatment of patients with dementia-related psychosis.
(Reporting by Sakthi Prasad in Bangalore; Editing by Jeremy Laurence)