It’s not too surprising to read that HMG-CoA reductase inhibitors (statins) are taken by millions of people worldwide. The drugs are taken to prevent heart attack, stroke and cardiovascular disease. In fact, Pfizer’s Lipitor was the highest grossing product on the market for years until it went generic. It was reported recently that Astra Zeneca’s statin, Crestor, accounts for approximately $4.5 billion in annual sales. Based on these numbers, considering the huge sales volumes, it’s quite evident that even a small increase in risk could result in significantly higher numbers of a particular adverse event each year.
Following the publication of a meta-analysis in 2010, which reported that statin therapy overall was associated with an increased risk of development of new onset diabetes (NOD), some regulatory agencies looked into all available data, both published and unpublished. The CHMP Pharmacovigilance Working Party (PhVWP) held a meeting in December 2011 to discuss this safety concern for European Medicines Agency.
From the analysis of the non-clinical and clinical data, the PhVWP concluded that there was sufficient evidence to support a causal association between the use of statins and NOD. However, according to the PhVWP, the risk does appear to be in patients already at an increased risk of developing diabetes. The committee did report that the benefits of statins still outweigh the risks, including this newly identified risk of NOD. The committee has recommended that the product labeling on all statins include a warning for patients at a higher risk of diabetes should be monitored both clinically and biochemically according to established guidelines to detect diabetes.
The Food and Drug Administration has now raised safety concerns about statins, warning that patients taking the drugs may face a “small increased risk” of higher blood sugar levels and of being diagnosed with diabetes. The FDA plans to add the diabetes-risk language to the “warnings and precautions” sections of labeling for the statin drugs. The drugs that will get the warning include brand names such as Lipitor, Lescol, Pravachol, Crestor, Mevacor, Altoprev, Livalo and Zocor.
The FDA also said that labels for statin drugs now will contain information about patients experiencing memory loss and confusion, though this side effect was classified as an “adverse reaction” rather than being put in the more serious warnings and precautions category. Dr. Amy Egan, the FDA’s deputy director for safety of metabolic and endocrinological products, said “these cognitive changes can be quite dramatic” and “sustained,” but that they do disappear when statin therapy is stopped. She cautioned that the agency isn’t able to identify a specific drug or age group of people who might be prone to such cases of memory loss and confusion, but that patients should notify their doctors if such symptoms occur.
Source: European Medicines Agency
Contact us today for a free legal consultation with an experienced attorney.
Fields marked *may be required for submission.
If you would like to subscribe to the Jere Beasley Report digital edition, simply visit our Subscriptions page and provide the necessary information or call us at 800-898-2034.
Attorney Advertising - Prior results do not guarantee a similar outcome.