New Study Highlights Statins and Diabetes Risk
Cholesterol lowering drugs, known as statins, and their potential side effects have been the topic of concern among health care practitioners, the FDA and consumers, as emerging research finds more evidence of serious risks. In 2012, the FDA announced updates on statin risks for Pfizer’s Lipitor, Merck’s Zocor and AstraZeneca’s Crestor – which are taken by millions of Americans every day. The agency cautioned that patients being treated with statins may be at an increased risk of raised blood sugar levels and Type 2 diabetes.
Now, a new study published in Diabetes, Obesity and Metabolism provides further evidence of the link between statins like Lipitor and diabetes. A team of researchers from Saint Luke’s Hospital and the University of Alabama note that the diabetes risk is small, but definite.
Lipitor and diabetes risk observed in other studies
In examining the relevance of statin-induced diabetes, the researchers concluded “Despite the fact that higher statin doses are more likely to lead to new-onset diabetes, for every case of diabetes caused, there are approximately three cardiovascular events reduced with high dose vs. moderate dose statin therapy.”
While statins prove statistically effective in reducing risk of heart disease, numerous studies have yielded inconclusive results regarding diabetes risk. In 2010, an analysis of thirteen clinical trials determined that patients who took statins had a 9 percent increased risk for diabetes. Whereas researchers from the University of Massachusetts Medical School found that women who used cholesterol-lowering medicine like Lipitor were 50 percent more likely to develop diabetes, compared to those who didn’t take statins. Some experts have noted that diabetes risk may be greater for middle–aged and post-menopausal woman.
Lipitor and its generic counterpart atorvastatin are one of the world’s top-selling prescription medications, earning Pfizer more than $130 billion in cumulative sales. But swelling litigation over statin side effects may prompt more doctors to give pause before prescribing the drugs, as increased blood sugar levels, confusion and memory loss and muscle weakness have been linked to the medications.
The FDA advisory last year cautioned the public about all of these side effects, though memory loss reports were anecdotal, and not proven through research.
Weighing the risks and benefits of statins
There is no denying that statin therapy has saved thousands of lives, and for some in the medical community the potential risks are far outweighed by the benefits. Despite last year’s FDA communication on statin risks, drug manufacturers like Pfizer continue to promote their products as safe and effective. The pharmaceutical giant has been named as defendant in hundreds of Lipitor side effects lawsuits, the majority of which were filed by women who developed diabetes after taking the drug.
Plaintiffs argue that they were not adequately warned about diabetes risks, and that the product information was misleading and inaccurate.
In the wake of mounting lawsuits involving Lipitor and diabetes, the U.S. Panel on Multidistrict Litigation will soon consider coordinating litigation for pretrial proceedings. After hearing oral arguments later this month, the panel may move forward with multidistrict litigation (MDL), which would transfer all claims brought in federal court before a single judge.
Attorneys continue to review product liability claims involving adverse Lipitor side effects, but as tens of millions of Americans currently take some type of statin, additional studies on diabetes risks are needed.
- Wiley Online Library, Is Statin-induced Diabetes Clinically Relevant? A Comprehensive Review of the Literature, http://onlinelibrary.wiley.com/doi/10.1111/dom.12254/abstract
- WebMD, Statins May Raise Diabetes Risk in Older Women, http://www.webmd.com/cholesterol-management/news/20120109/statins-may-raise-diabetes-risk-in-older-women?page=2
- FDA, FDA Expands on Statin Risks, http://www.fda.gov/forconsumers/consumerupdates/ucm293330.htm
- Reuters, FDA adds diabetes, memory loss warnings to statins, http://www.reuters.com/article/2012/02/28/us-fda-statins-idUSTRE81R1O220120228