Atorvastatin generic (Lipitor®)
Manufacturer: Pfizer, Inc.
Indication: This medication is an adjunct to diet and exercise to reduce elevated total cholesterol (TC), low-density lipoprotein-cholesterol (LDL-C), apolipoprotein B (apoB), and trigylceride (TG) concentrations and to increase high-density lipoprotein-cholesterol (HDL-C) in patients with primary hypercholesterolemia and mixed dyslipidemia.
Rationale for FDA Alert: Albers Medical Distributors, Inc., has voluntarily recalled three lots of 90-count, National Drug Code 0071-0155-23. Med-Pro, Inc., of Lexington, Nebraska, repackaged the product, and the labels say “Repackaged by Med-Pro, Inc., Lexington, NE” in the lower left-hand corner. The following lot numbers were affected:
The Food and Drug Administration (FDA) has indicated that these products are or might be counterfeit and that their distribution should be stopped. This recall extends to the consumer level. The FDA has urged both health care providers and patients to check the packaging carefully before using this product. Patients who have this product, with any of these three lot numbers, should not ingest it and should return it to their pharmacies.
On June 17, 2003, the FDA expanded its recall of certain Lipitor® products and all Lipitor canadian products repacked by Med-Pro (with the designation number 68850) and distributed by Albers in Kansas City, Missouri, and H.D. Smith Wholesale Drug Company in Springfield, Illinois. Conclusion: In conjunction with the FDA, Albers expanded the original voluntary recall to include all of the atorvastatin lots that it had purchased that were packaged by Med-Pro, Inc. Although the FDA has not tested all of the additional lots, Albers is voluntarily recalling them as a precautionary measure.
Risperidone (Risperdal generic)
Manufacturer: Janssen Pharmaceutica
Indication: Risperidone is indicated for the treatment of schizophrenia.
Rationale for Labeling Review: In four placebo-controlled trials involving elderly patients with dementia-related psychosis (n = 1,230), the incidence of cerebrovascular adverse events (e.g., stroke, transient ischemic attack), including fatalities, was significantly higher in patients taking than in patients taking placebo. Label Change Warning: Cardiovascular Adverse Events, including Stroke, in Elderly Patients with Dementia. Cardiovascular adverse events, including fatalities, were reported in placebo-controlled trials of risperidone in elderly patients (mean age, 85 years; range, 73-97) with dementia-related psychosis. The incidence of cerebrovascular adverse events in the patients taking risperidone was significantly higher than in those taking placebo. Risperidone has not been shown to be safe or effective in the treatment of these patients. Conclusion: In the spring of 2003, a new paragraph was added to the package insert for risperidone concerning an increased frequency of cerebrovascular adverse events in clinical trials of elderly patients with dementia-related psychosis who took risperidone canadian for two years compared with the frequency in patients taking placebo. Mortality rates for cerebro-vascular adverse events were comparable between the two treatment groups. Based on a decision by the FDA, the label change is limited to geriatric patients with dementia; according to the manufacturer, however, risperidone is not indicated for the treatment of dementia, as is true for other antipsychotic drugs