Bring An Equalizer to the Fight. Choose a Firm That Was Created to Advocate for Victims.

FDA Releases New Safety Information for Cholesterol Drugs

The Food and Drug Administration has released new drug safety information on certain medications designed to lower cholesterol. The new information specifically addresses several newly identified side effects of common cholesterol-lowering drugs called statins.

According to the FDA, the regulator is particularly concerned about risks of memory loss, diabetes and muscle pain, and will be changing the labels on popular drugs like Crestor (rosuvastatin), Lipitor (atorvastatin), Pravachol (pravastatin), and Zocor (simvastatin) to reflect those concerns.

Despite the new warning, Amy G. Egan, M.D., M.P.H., deputy director for safety in FDA’s Division of Metabolism and Endocrinology Products (DMEP), says patients do not need to stop taking the drugs. “The value of statins in preventing heart disease has been clearly established,” she says. “Their benefit is indisputable, but they need to be taken with care and knowledge of their side effects.”

Below is additional information provided by the FDA regarding the potential side effects of these medications:

  • Reports of Memory Loss: The FDA has been investigating reports of cognitive impairment from statin use for several years. The agency has reviewed databases that record reports of bad reactions to drugs and statin clinical trials that included assessments of cognitive function. The reports about memory loss, forgetfulness and confusion span all statin products and all age groups. Egan says these experiences are rare but that those affected often report feeling “fuzzy” or unfocused in their thinking. In general, the symptoms will reverse after the patient stopped using the statin.
  • The Risk of Diabetes: A small increased risk of raised blood sugar levels and the development of Type 2 diabetes have been reported with the use of statins. “Clearly we think that the heart benefit of statins outweighs this small increased risk,” says Egan. But what this means for patients taking statins and the health care professionals prescribing them is that blood-sugar levels may need to be assessed after instituting statin therapy,” she says.
  • The Potential for Muscle Damage: Some drugs interact with statins in a way that increases the risk of muscle injury called myopathy, characterized by unexplained muscle weakness or pain. FDA is revising the drug label for Lovastatin to clarify the risk of myopathy. The label will reflect what drugs should not be taken at the same time, and the maximum lovastatin dose if it is not possible to avoid use of those other drugs.

If you or someone you love has been seriously injured by a dangerous or defective drug, don’t hesitate tocontact a San Diego product liability attorney at the Law Offices of Robert Vaage for a free consultation.