In March 2012, the FDA announced that manufacturers of cholesterol-lowering statin drugs like Lipitor (atorvastatin) would be updating warning labels to alert patients and doctors to the risk of memory loss, confusion, and an increase in blood sugar levels and type 2 diabetes. These drugs are also associated with muscle damage and wasting, called “myopathy.” The agency made their decision based on clinical trial meta-analyses and epidemiological data from the published literature.
What Is Lipitor?
Manufactured by Pfizer, Lipitor first came on the market in 1996. A member of a class of drugs called “HMG CoA reductase inhibitors,” the drug helps reduce LDL “bad” cholesterol and blood triglycerides as well as helping to increase levels of HDL “good” cholesterol. Doctors use it to help reduce total cholesterol levels and lower patients’ risk of heart disease and stroke.
The drug works by suppressing an enzyme in the liver (called HMG-CoA reductase) that is vital in the process of producing cholesterol.
Lipitor Serious Side Effects
Like most drugs, Lipitor comes with potential side effects, but some are particularly serious. It may cause muscle problems, including aches and pains, weakness, and actual muscle wasting, where tiny pieces of the muscle fiber are worn away and flushed out through the body’s waste system. Without treatment, this problem can eventually overtax the ability of the kidneys to clean out the blood, resulting in a type of kidney disorder called “rhabdomyolysis” that can eventually lead to kidney failure.
Lipitor may also increase the risk of liver problems. The FDA recommends liver enzyme tests be performed before a patient starts taking the medication when clinically indicated. Memory loss and confusion may occur anywhere from one day after starting therapy, or even years afterward.
Lipitor Diabetes In Women
The FDA’s meta-analysis, which included 13 statin trials with over 90,000 participants, found that statin therapy was linked with a nine percent increased risk for type 2 diabetes. A number of other studies have found similar results:
- 2013: Research published in Circulation: Cardiovascular Quality and Outcomes, reported that 13.6 percent of patients receiving intensive statin therapy had a new diagnosis of diabetes. 13.0 percent of patients receiving moderate-dose statin therapy also had a new diagnosis of diabetes.
- 2013: For a study published in BMJ, researchers looked at data from 1.5 million residents in Ontario, Canada, all aged 66 and over and who started statin therapy between 1997 and 2010. Patients taking Lipitor were found to have a 22 percent increased risk of new-onset diabetes.
- 2012: In a scientific article published in Circulation, researchers stated, “Careful review of findings from many trials combined does show that statins can modestly raise blood sugars, and more patients who are on statin therapy are diagnosed with diabetes mellitus compared with those not on statins.
- 2012: In a study analysis published in The Lancet, researchers noted that in the JUPITER trial, in individuals with one or more risk factors for diabetes, statin use was associated with a 28 percent increase in diabetes.
- 2012: A study published in Arch Intern Med. reported that statin use in postmenopausal women was associated with an increased risk of diabetes. In the study, 6.4 percent of women not taking statins developed diabetes, while nearly 10 percent of women using them developed the disease.
- 2010: In a collaborative meta-analysis of randomized statin trials published in The Lancet, researchers concluded that statin therapy was associated with a slightly increased risk of the development of diabetes.
- 2009: The JUPITER trial looks at the use of statins in prevention of heart attacks and strokes, and found small increases in physician-reported diabetes in patients using statin drugs.
“I don’t think there’s any debate remaining,” cardiologist Steve Nissen of the Cleveland Clinic told USA Today, “particularly in the higher doses, about whether statins slightly increase the risk of developing diabetes.”
Patients who have taken Lipitor and then suffered serious injuries often state that had they known the whole truth about the risks, they never would have taken the drug. Many have filed a Lipitor lawsuit against Pfizer for failing to provide necessary warnings at an earlier date, and for failing to conduct adequate safety studies before releasing the drug on the market.
If you or a loved one suffered an injury that you believe to be the result of Lipitor, contact an experienced Lipitor lawyer today. We can provide you with a complimentary consultation that will help you determine your next steps. If you decide to pursue compensation, we won’t rest until we have done everything possible to recover damages for you.