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Lipitor’s Dangers Lead to FDA Safety Advisory

Published on Aug 16, 2013 at 12:39 pm in Dangerous Drugs.

Kentucky Dangerous DrugsLipitor is part of a group of cholesterol-lowering drugs called statins. Statins are designed to decrease the “bad” cholesterol and increase the “good” cholesterol in the blood. They are taken by tens of millions of Americans and are overall found to be successful at reducing heart attacks.

However, some concerns have been raised about possible side effects of statins. In 2012, the US Food & Drug Administration (FDA) issued a safety advisory, warning that statins in general (popular brands include Lipitor and Crestor) can raise the risk of developing diabetes and cause episodes of cognitive problems (mental impairment). The warnings concern statins in general and Lipitor in particular.

FDA Warns about Statins in General

The FDA issued this warning after the results of ongoing clinical trials on statins were analyzed: “A small increased risk of raised blood sugar levels and the development of Type 2 diabetes have been reported with the use of statins.”

The FDA clarified that it still believes the benefits of statins overall outweigh the “small increased risk.” However, the FDA cautioned that “blood-sugar levels may need to be assessed after instituting statin therapy.”

Reports of side effects including memory loss, forgetfulness, and confusion came from all statin products and all ages of consumers, according to the FDA. These effects are noted as rare. They were reversible within a few weeks of stopping use of statins.

FDA Demands that Pfizer Re-Label Lipitor

In 2012, the FDA did demand that Pfizer, the manufacturer of Lipitor, update its drug label to show a risk of type-2 diabetes. Some studies have reported a link between Lipitor and women developing type-2 diabetes. The FDA stopped short of ordering a recall of Lipitor.

Many people are able to continue taking Lipitor. Some experts suggest discussing with your doctor your relative risk for heart failure, and weighing that against the risk of any potential side effects.

Some patients who have taken Lipitor and developed diabetes have held Pfizer liable for injuries through dangerous drug lawsuits. If you developed type 2 diabetes while taking Lipitor, or are currently taking Lipitor, have a doctor run tests to learn about any potential side effects you may be experiencing.