FDA announces New Safety Concerns for Statins

Medication bottle - BSN

(Best Syndication News) - Cholesterol lowering medications prescribed by doctors have new important safety information announced by the Food and Drug Administration (FDA). These include not needing to do routine blood tests for liver enzymes, memory loss problems, increased diabetes risk, and muscle damage risk.

The FDA is advising health care professionals that routine blood tests for liver enzymes are no longer necessary because they did not prove to be helpful in preventing rare cases of serious liver injury that can happen when taking statins.

Memory loss, forgetting, and being confused have been reported as a side effect from some people taking statin medications. The memory loss was described as being “fuzzy.” The FDA said that the memory loss was reversible once the person stopped taking the medication.

Statin medications could increase the risk for developing Type 2 diabetes. The risk comes from higher blood sugar levels. The blood sugar levels were a mild increase; however, the FDA suggests that doctors monitor blood sugar levels after starting a person on statins.

The last risk is with taking lovastatin medications with some other medications because it could cause muscle damage, which is called myopathy. The symptoms of myopathy are unexplained muscle weakness or pain.

The FDA will be making an updated notice that comes with the medication and is given out on an information sheet about the medication’s side effects. The statins involved in this updated side effect information is Altoprev (lovastatin extended-release), Crestor (rosuvastatin), Lescol (fluvastatin), Lipitor (atorvastatin), Livalo (pitavastatin), Mevacor (lovastatin), Pravachol (pravastatin), and Zocor (simvastatin). Also involved are combination medications that contain statins: Advicor (lovastatin/niacin extended-release), Simcor (simvastatin/niacin extended-release), and Vytorin (simvastatin/ezetimibe).

Amy G. Egan, M.D., M.PH., deputy director for safety in FDA’s Division of Metabolism and Endocrinology Products (DMEP) said that even though the side effects are there, statin medications have been beneficial for preventing heart disease and people should not be scared to take them. Any concerns about taking statins should be discussed with your doctor.

By: Marsha Quinn
Health Reporter

ref: FDA

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