Pfizer Seeks OTC Approval, as Lipitor Lawsuits Mount

March 10, 2014
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Pfizer is seeking OTC approval for Lipitor, the largest selling drug of all time.  They’ve begun a clinical study of 1200 patients to find out if they can appropriately measure their LDL cholesterol levels.  Lipitor (atorvastatin) is a statin – a class of drugs that blocks the action of a chemical in the liver that makes cholesterol.  Other companies have failed to win OTC approval for statins in the past.  In particular, Merck made several attempts to get OTC approval for lovastatin (Mevacor).

Meanwhile, lawsuits continue to mount against Pfizer, alleging that Lipitor caused patients to develop new-onset Type 2 diabetes.  In early 2012, the FDA mandated a change in safety labels for cholesterol-lowering drugs known as statins regarding blood sugar levels.  This was shortly after a study appeared in JAMA: Internal Medicine, suggesting post-menopausal women who take statin drugs may be at an increased risk for diabetes.

According to court documents, there are over 60 lawsuits in multidistrict litigation in South Carolina District court.  At least 170 other claims may be added, according to the order establishing multidistrict litigation.

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