FDA Safety Warning for Lipitor and Diabetes

The U.S. Food and Drug Administration (FDA) has issued numerous warnings about the risk of Lipitor and type-2 diabetes. Studies have found that the risk of diabetes is especially high for post-menopausal women. Pfizer, the manufacturer of Lipitor, is facing a growing number of Lipitor lawsuits for allegedly failing to warn about the risk of diabetes.

FDA Safety Warning for Lipitor and Diabetes

On April 11, 2012, the FDA issued a Consumer Update to warn about important new safety information about cholesterol-lowering medications known as statins. The most popular statin, Lipitor, is associated with elevated blood sugar levels (“hyperglycemia”), which can lead to serious health problems, including type-2 diabetes.

According to the FDA:

“People being treated with statins may have an increased risk of raised blood sugar levels and the development of Type 2 diabetes.”

FDA Requires Label Updates on Lipitor

In April 2012, Pfizer, the manufacturer of Lipitor, was forced to update the label on Lipitor to warn about the risk of blood-sugar problems. Unfortunately, many people are concerned that these warnings were too little, too late, and they still do not adequately or clearly warn about the potential risk of diabetes.

According to the Lipitor Prescribing Information, the new label on Lipitor includes this warning:

“Increases in HbA1c and fasting serum glucose levels have been reported with HMG-CoA reductase inhibitors, including Lipitor.”

FDA: Lipitor Patients May Need Blood-Sugar Tests

The FDA believes that the risk of Lipitor and type-2 diabetes is outweighed by the cardiovascular benefits of taking Lipitor for some patients. However, they do recommend: “Blood-sugar levels may need to be assessed after instituting statin therapy.”

Routing blood-sugar tests may be a good idea for people who have multiple risk-factors for type-2 diabetes. According to the FDA, the main risk-factors for diabetes include:

• Family history of diabetes
• Being overweight (especially around the waist)
• Inactive or sedentary lifestyle (exercising less than 3 times a week)
• And more

Studies of Lipitor and Diabetes

In February 2012, the FDA issued a Drug Safety Communication about a possible link between Lipitor and diabetes based on a meta-analysis of 13 studies involving more than 90,000 patients. These studies found a 9% increased risk of diabetes associated with statins. A meta-analysis of 6 other studies involving 60,000 people also found a small increased risk of diabetes.

Clinical trials linking statins and diabetes include:

• Pravastatin or Atorvastatin Evaluation and Infection Therapy – Thrombolysis In Myocardial Infarction 22 (PROVE-IT TIMI 22): High-dose Lipitor was (80-mg) associated with worsening blood-sugar control.
• Justification for the Use of Statins in Primary Prevention: an Intervention Trial Evaluating Rosuvastatin (JUPITER): Reported a 27% increase in investigator-reported type-2 diabetes in patients on Crestor.

FDA Safety Warning for Lipitor and Diabetes in Post-Menopausal Women

In January 2012, the Archives of Internal Medicine published a study of more than 160,000 post-menopausal women (aged 50-79 years old) with data collected between 1993 and 2005. Researchers found that post-menopausal women who took statins were 50% more likely to report a diagnosis of type-2 diabetes than women who did not take statins.

The FDA issued the following warning about the risk:

“A recent study by Culver et al., using data from the Women’s Health Initiative, reported that statin use conveys an increased risk of new-onset diabetes in postmenopausal women, and noted that the effect appears to be a medication class effect, unrelated to potency or to individual statin.”