Wednesday, June 08, 2011

FDA makes two wise decisions in one day

Zocor (Simvastatin)
The highest approved dose of simvastatin -- 80 mg -- should be used only in those patients who have already been taking it for at least 12 months without signs of myopathy, the FDA announced Wednesday. The 80-mg dose should not be used in new patients or those taking lower doses of the drug who need to lower their cholesterol further, the agency said in a safety alert, which outlined label changes and dose limitations for the drug. The FDA first announced that the 80-mg dose of simvastatin was associated with an increased risk of myopathy and rhabdomyolysis in March 2010, but the agency did not make specific recommendations about limiting its use pending a formal safety review.The labels of both generic and branded (Zocor) forms of simvastatin, as well as the label for the simvastatin-ezetimibe combination (Vytorin), have been changed to reflect the new dosing limitations.Three other medications -- gemfibrozil, cyclosporine, and danazol -- were shifted from acceptable use with low-dose simvastatin to the contraindication category. Amiodarone, verapamil, and diltiazem should not be used with more than 10 mg of simvastatin daily, according to the new labels, which is lower than the previously acceptable dose. In addition, patients who are taking amlodipine and ranolazine (Ranexa) should take no more than 20 mg of simvastatin daily.

Poultry Drug Sales Suspended
Pfizer has agreed to suspend U.S. sales of a popular poultry drug after a study found the drug increased levels of a carcinogen in chickens, according to U.S. health officials. A study from the Food and Drug Administration found that chickens treated with Pfizer's 3-Nitro drug had higher levels of inorganic arsenic, a known cancer-causing substance. Arsenic is an odorless and tasteless element that occurs naturally in water, air, soil and food and comes in two types. Organic arsenic, which is present in 3-Nitro, is thought to be harmless. But recent scientific reports have indicated that organic arsenic could transform into inorganic arsenic, a known human carcinogen. Following up on the reports, FDA scientists detected higher levels of inorganic arsenic in the livers of chickens treated with 3-Nitro compared to the livers of chickens not treated with the drug. Recent tests by nonprofit watchdogs have found conventional chickens to be high in arsenic. This drug may be one reason why.

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