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FDA Safety Warning: Lipitor and Diabetes


In response to a growing number of studies linking Lipitor and type-2 diabetes, the U.S. Food and Drug Administration (FDA) has issued new warnings and required label updates. The manufacturer of Lipitor, Pfizer Inc., is facing a growing number of lawsuits accusing them of failing to adequately warn about the risk of diabetes from Lipitor.

FDA Safety Warning for Lipitor and Diabetes

The FDA published the following Consumer Safety Update for Lipitor on April 11, 2012. They warned about new studies linking all cholesterol-lowering statins, including Lipitor, to elevated blood-sugar levels (“hyperglycemia”) and 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, the FDA required Pfizer Inc. to update the warning information on Lipitor to include risk-information about elevated blood-sugar problems. Unfortunately, many lawsuits allege that these warnings were too little, too late, and they are still inadequate to inform people and their doctors about the risk of Lipitor and diabetes.

According to the Lipitor Prescribing Information, the label on Lipitor was changed to add the following 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

Patients who are at risk of developing type-2 diabetes while using Lipitor may need to have blood-sugar tests — especially for people who have multiple risk-factors for diabetes. The FDA believes that the cardiovascular benefit outweighs the risk of diabetes for most patients, but they recommend: “Blood-sugar levels may need to be assessed after instituting statin therapy.”

The main risk-factors for type-2 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 in response to the following studies of Lipitor and diabetes. One study, a meta-analysis of data on more than 90,000 people in 13 studies, associated statins with a 9% increased risk of diabetes. A small increased risk of diabetes was also found in a meta-analysis of 6 other studies involving nearly 60,000 people.

Diabetes was associated with statins in the following clinical trials:

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

Lipitor was associated with a 50% increased risk of type-2 diabetes among post-menopausal women, according to a study published in the Archives of Internal Medicine in January 2012. The study involved data from 1993-2005 on more than 160,000 post-menopausal woman (aged 50-79 years old).

The FDA warned:

“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.”

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