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Lipitor, Women and the Risk of Diabetes

We have begun reviewing claims involving Lipitor which is a member of the drug class known as statins. It is prescribed to reduce cholesterol. Parke-Davis Pharmaceutical Research, a division of Warner-Lambert Company, obtained approval from the Food and Drug Administration (FDA) to market Lipitor on December 17, 1996. Warner-Lambert entered into a co-marketing agreement with Pfizer to sell Lipitor, and thereafter those companies began distributing and selling Lipitor in the United States in 1997. On June 19, 2000, Pfizer acquired Warner-Lambert and all rights to Lipitor.

Despite knowledge of data indicating that Lipitor use is causally related to the development of type 2 diabetes and the lack of demonstrated efficacy in women for prevention of heart disease, Pfizer promoted and marketed Lipitor as safe and effective.

On August 11, 2011, the Division of Metabolism and Endocrinology Products of the FDA requested that Pfizer make labeling changes for Lipitor based upon the FDA’s comprehensive review, including clinical trial data. In February 2012, Pfizer complied with the FDA request and added the following language to its Warnings and Precautions Section: “Increases in HbA1c and fasting serum glucose levels have been reported with HMG-CoA reductase inhibitors, including Lipitor.” Until the February 2012 change, Lipitor’s label had never warned patients of any potential relationship between changes in blood sugar levels and taking Lipitor.

We are currently investigating bad drug claims involving women under the age of 75 who have been diagnosed with diabetes at the time they were taking Lipitor. The claimant must also have had a body mass index of 32 or less when they were diagnosed and they must have taken Lipitor for at least 30 days. We are not reviewing cases that involve the generic brand of Lipitor.

As with all medications, you should not stop taking Lipitor until you have consulted with your physician.

If you have been injured as a result, please call Younce, Vtipil, & Baznik, P.A., or contact us online.

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