Merck & Co. Inc. (Active Pharmaceutical Ingredient Watch).(alters Zocor label)(Brief Article)

Chemical Market Reporter, June, 2002

MERCK & Co. Inc. reports that changes to the existing label for cholesterol-lowering drug Zocor (simvastatin) further clarify the risk of myopathy and rhabdomyolysis, particularly with higher doses and when used with certain drugs. Merck requested the change as part of normal post-marketing surveillance and monitoring of ongoing clinical trials.

Both conditions are well known side effects of all statins. "Although the competitors, Pfizer Inc.'s Lipitor and Bristol-Myers Squibb Company (BMS)'s Pravachol (pravastatin), also have this risk those less threatening labels are not expected to be revised," says JP Morgan analyst Carl Seiden. "If Pfizer and BMS counter-detail Zocor on this issue (they might not for fear of tainting the entire class) than this could...

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