Federal health regulators are warning that cholesterol lowering drugs like Lipitor, Crestor and Zocor could increase the risk of diabetes, muscle injury and could cause memory loss and confusion.
The FDA announced this week that it was requiring new label warnings on a number of drugs known as statins to alert the public.
The drugs affected by the new label warnings include: Advicor, Altoprev, Crestor, Lescol, Lipitor, Lovalo, Mevacor, Pravachol, Simcor, Vytorin and Zocor.
Statins are the best-selling drugs in the United States, they target the liver to block the production of cholesterol, which is a key contributor to coronary artery disease.
The new label warnings will include information from a number of studies that suggest that statins increase the level of blood sugars, resulting in an increased risk of Type 2 diabetes.
Concerns over cognitive impairments came from a review of the FDA’s adverse events reporting system (AERS) database as well as clinical trials. The agency received a number of adverse event reports that warned that some statin users over the age of 50 suffered memory loss and confusion while taking statins.
Statins have been linked to muscle damage. Studies have found that about 1 in 10,000 statin users develop a sometimes-fatal muscle condition known as rhabdomyolysis. The rare condition causes skeletal muscle damage and releases myoglobin into the bloodstream. The myoglobin can cause severe kidney failure or death.
In June 2011, the FDA updated the warning label about the risk of rhabdomyolysis from Zocor 80mg doses, specifically indicating that users may face an increased risk when that higher dose statin is used.
Shezad Malik is an Internal Medicine and Cardiology specialist, a licensed Texas Medical Doctor and Defective Medical Device and Dangerous Drug Attorney. Dr Shezad Malik Law Firm has offices based in Fort Worth and Dallas and represents people who have suffered catastrophic and serious personal injuries including wrongful death, caused by the negligence or recklessness of others.