Report: GSK recalls blood-pressure drug made at Novartis plant
NEW YORK — GlaxoSmithKline has recalled nearly 400,000 bottles of a hypertension drug that were distributed in the United States, according to published reports.
Reuters Health reported that GSK was recalling 394,230 bottles of its DynaCirc CR after the drug’s manufacturer, Novartis, reported inconsistent packaging practices. The generic drug is manufactured at a Novartis plant in Lincoln, Neb.
No adverse events were reported, GSK was quoted as saying, but the drug maker elected to put forth a recall as a precautionary measure.
Statins could increase blood sugar, cause cognitive problems, FDA says
SILVER SPRING, Md. — Drugs widely used to treat cholesterol may cause increases in blood sugar and other symptoms, the Food and Drug Administration said Tuesday.
The FDA announced that it would update the safety labeling for statin drugs to include the risk of increased blood sugar, or hyperglycemia, memory loss and confusion and risks associated with using certain statins with drugs for treating infections. In addition, the agency is recommending that patients undergo liver enzyme tests before starting statin therapy and as needed thereafter; previously, guidelines called for routine monitoring.
Statins include a wide range of drugs, branded and generic, such as Pfizer’s Lipitor (atorvastatin); Novartis’ Lescol (fluvastatin); Bristol-Myers Squibb’s Pravachol (pravastatin); AstraZeneca’s Crestor (rosuvastatin); and Merck’s Mevacor (lovastatin).
In particular, the agency said, Mevacor should not be used by patients taking drugs for treating HIV, bacterial and fungal infections due to the risk of muscle injuries.
Glenmark recalls seven lots of contraceptive drug
NEW YORK — The U.S. unit of Indian generic drug maker Glenmark is recalling a generic contraceptive drug, the company said.
Glenmark Generics USA announced the recall of seven lots, imported from India, of norgestimate and ethinyl estradiol tablets in the 0.18-mg/0.035-mg, 0.215-mg/0.035-mg and 0.25-mg/0.035-mg strengths. The company said a packaging error resulted in blister packs being rotated 180 degrees within the card, reversing the weekly tablet orientation and making the lot number and expiration date visible only on the outer pouch.
The company said the error may result in the daily regimen for the drug being incorrect and leave women without adequate contraception.