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Pravastatin Reduces Mortality 10 Years After Use – Study

This article was originally published in The Tan Sheet

Executive Summary

Results of a follow-up primary prevention trial finding treatment with pravastatin provided ongoing cardiac event risk reduction 10 years later could strengthen the case for OTC statins

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NDAC joint panel planned

FDA's drug center has tentatively scheduled a joint meeting of its Endocrinologic and Metabolic Drugs Advisory Committee and its Nonprescription Drugs Advisory Committee for Dec. 13 and 14. The agency will not discuss the planned topic until publishing a Federal Register notice announcing a confirmed meeting. Previously, the agency convened the same joint panel to consider the suitability of statins, including Merck's Mevacor (lovastatin) and Bristol-Myers Squibb's Pravachol (pravastatin) for OTC sale, and to review GlaxoSmithKline's weight-loss drug alli (orlistat) for an Rx-to-OTC switch. Bayer, which now holds the OTC rights for Pravachol, is pursuing an active program to switch the drug to OTC, while J&J/Merck is still seeking a switch for Mevacor (1"The Tan Sheet" July 2, 2007, In Brief)...

Statin Benefits Outweigh Liver Toxicity Risks In Most Patients – Editorial

The benefits of statins offset the potential risks of liver toxicity in most patients, but the drugs may be inappropriate for certain subgroups in an OTC setting, according to a recent editorial in the American Journal of Cardiology

Novel Omega-3 Formulation Found To Shrink Colorectal Polyps

A high-dose, purified form of an omega-3 fatty acid shrunk colorectal polyps about as effectively as the non-steroidal anti-inflammatory drug commonly used to treat them, but without the associated cardiovascular risks, according to findings from a trial published in the journal Gut





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