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Lipitor FDA Diabetes Warning

Lipitor FDA Warning

The Lipitor FDA diabetes warning was issued on February 28, 2012. This official safety communication announced changes to the product’s safety label, including a new warning about the risk of high blood sugar for patients taking Lipitor and other statins. The Lipitor FDA diabetes warning, which was accompanied by other cautions about the potential for memory loss and liver problems also being associated with patients taking Lipitor, is the result of a thorough review of clinical studies and medical literature on the subject. This warning serves as a caution to doctors and patients; just because a drug is widely prescribed and used by more Americans than any other does not mean it is necessarily safe.

Lipitor Diabetes Warning Added to Packaging

Lipitor was first approved by the FDA for general use in 1996. Used to lower the body’s production of bad cholesterol in order to prevent cardiac disease and heart attack, Lipitor has been at the top of the list of best-selling drugs for many of its years on the market. Total sales of Lipitor in the past fifteen years have climbed over $130 billion.

Lipitor and other statin drugs are widely prescribed to patients in order to lower the risk of cardiac disease and heart attack by inhibiting the production of an enzyme in the liver that leads to the accumulation of bad cholesterol. Cardiac problems are, however, also a potential side effect of diabetes. Patients who have taken Lipitor in order to prevent cardiac problems, only to develop diabetes and thus an increased risk of cardiac complications, were not adequately warned about the risks associated with Lipitor prior to the 2012 Lipitor FDA diabetes warning.

Lipitor Diabetes Warning

Studies cited by the FDA Lipitor diabetes warning include the study published in the Lancet in 2010 and the Women’s Health Initiative study from 2012. The Lancet study establishes the low level of diabetes risk for anyone taking Lipitor, whereas the Women’s Health Initiative study indicates a much higher level of risk of diabetes for the specific population of elderly women.

A study spearheaded by Dr. David Water, of the University of California at San Francisco, and published in the Journal of the American College of Cardiology in March of 2011 further confirmed the Lipitor diabetes risk findings that are the subject of the Lipitor FDA warning. Comparing patients that took high doses of Lipitor, low doses of Lipitor and a placebo, this investigation found that patients taking any amount of Lipitor experienced a 37% increase in the risk of developing diabetes. Researchers involved in the study ultimately concluded that the risks associated with taking Lipitor as outlined in the Lipitor FDA diabetes warning did not outweigh the benefits of the drug for heart health. It should be noted that several members of the research team are employed by Pfizer.

Despite Lipitor FDA Warning, Patients Advised to Keep Taking Lipitor

Lipitor is the most common among many different types of statin drugs which are all used for the same purpose of improving heart health. The FDA Lipitor warning applies to all statin drugs. To date, no marked differences have been distinguished amongst the various statin drugs in terms of risk for diabetes. Instead, it is the patient’s particular demographic and makeup that affects the level of risk of developing diabetes. Postmenopausal women face nearly a 50% increase for developing diabetes when taking Lipitor. Despite the high level of risk for developing diabetes, the FDA Lipitor diabetes warning does not caution elderly women specifically from taking the drug. Many medical professionals have independently urged doctors and patients to seek alternative therapies such as weight loss, diet and exercise before resorting to statins in light of the findings revealed in the FDA Lipitor diabetes warning. However, the FDA and Pfizer still recommend that patients continue taking the drug.

Lipitor Diabetes Risk Factors

Risk factors for developing diabetes while taking Lipitor are related to age, weight, and body mass index. Among the general public, persons already predisposed to diabetes (mainly the obese and persons with cardiac disease) experience the highest risk of developing diabetes while on Lipitor. However, in the case of elderly women, who the FDA Lipitor diabetes warning note have the highest level of risk for developing diabetes, women who weigh less or have a lower BMI are actually at a higher risk of developing the disease. Researchers are not yet certain why this is the case, but for one reason or another, the drug’s adverse effects on elderly women is uniquely severe. Anyone taking Lipitor may be at risk for developing diabetes and complications of that disease. To better understand whether you have grounds for a Lipitor diabetes lawsuit, contact a Lipitor diabetes lawyer for a free consultation.