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FDA: Cholesterol Drug

March 7, 2012 by · Comments Off on FDA: Cholesterol Drug 

FDA: Cholesterol Drug, The FDA has requested more data from Merck on the company’s investigational cholesterol-lowering drug that combines ezetimibe (Zetia) and generic atorvastatin (Lipitor).

In a complete response letter, the FDA said it has completed its review of the company’s new drug application but will need additional information before moving forward, according to a statement from Merck.

There was no indication from the agency as to whether the request would delay approval of the drug. Merck said new data about the drug — known as MK-0653C — will be available later this year.

Merck’s combination of ezetimibe and simvastatin (Zocor), known as Vytorin, has been available for more than a decade. However, enthusiasm for the drug has waned in recent years, particularly in the wake of the disappointing ENHANCE trial results.

In ENHANCE, the use of Vytorin in patients with heterozygous familial hypercholesterolemia did not slow down the progression of atherosclerosis, which was measured via carotid intima-media thickness.

Cholesterol Drugs

March 1, 2012 by · Comments Off on Cholesterol Drugs 

Cholesterol Drugs, Federal health officials are adding new safety warnings about risks of memory loss and elevated blood sugar to statins, a widely prescribed group of cholesterol-lowering medications.

The Food and Drug Administration said Tuesday it is making labeling changes to medicines like Pfizer’s Lipitor, AstraZeneca’s Crestor and Merck & Co. Inc.’s Zocor. The drugs are used by tens of millions of U.S. patients to help prevent heart related problems associated with cholesterol.

New labeling on all such drugs will warn of memory loss and confusion reported among certain patients taking statins. The problems were generally not serious and went away after patients stopped taking the drugs, according to the FDA.

The updated labels will also mention elevated levels of blood sugar, associated with diabetes, that have been reported in some patients taking statins. A growing number of studies published over the last five years have found a link between statin use and type 2 diabetes. Last June, a report in the Journal of the American Medical Association analyzed five older randomized trials and concluded the increased risk was small but real for people taking higher doses of any statin.

Statins are mainly prescribed to prevent heart attacks in people with clogged arteries and work by dramatically lowering LDL or “bad cholesterol.” They were the third best-selling drug class in the U.S. for 2010 with sales of $18.8 billion.

In addition to the label additions, the FDA said it will remove a long-standing warning related to liver injury. The drugs label previously recommended routine testing of liver enzymes to avoid injury. The agency now recommends a single test when patients first begin taking statins.

“FDA has concluded that serious liver injury with statins is rare and unpredictable in individual patients, and that routine periodic monitoring of liver enzymes does not appear to be effective in detecting or preventing this rare side effect,” the agency said in a statement.

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