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myopathy 6 articles

FDA rejects consumer group’s request for black box warning on statin drugs

Cholesterol-lowering statin medication will not carry a black box warning for a deadly muscle disorder, the Food and Drug Administration (FDA) announced. The agency was petitioned by the consumer watchdog group Public Citizen, urging the FDA to force drug makers to alert consumers of the risk of rhambdomyolysis, a condition in which muscle cells break down and enter the bloodstream where they can damage the kidneys. Public Citizen filed its petition in 2001, not long after Bayer pulled its statin drug Baycol (cerivastatin) off the market after mounting reports of patients dying from the condition while taking the medication. The ... Read More

Drug-drug interaction with statins may cause serious muscle injury

Just a week after the Food and Drug Administration (FDA) issued new warnings for an increased risk of diabetes and memory loss with cholesterol-lowering statins, the agency is alerting the public about the risk of muscle injury associated with the drugs if used with certain HIV or hepatitis C medications known as protease inhibitors. The labels for both protease inhibitors and statins has been updated to warn that protease inhibitors and statins, when taken together, may raise blood levels of statins and increase the risk for muscle injury (myopathy). The most serious type of myopathy, called rhabdomyolysis, can damage the ... Read More

Is it safe to sell cholesterol-lowering drugs without a prescription?

Cholesterol-lowering statins were the most prescribed medication in 2010, and drug maker Pfizer hopes to make its drug Lipitor even more widely available by making it available over-the-counter, without a prescription. Statin medications are a class of drugs used to lower cholesterol levels by inhibiting the enzyme HMG-CoA reductase, which plays a central role in the production of cholesterol in the liver. High cholesterol levels have been linked to cardiovascular disease, the leading cause of death in the United States, according to the National Institutes of Health. Side effects associated with statin medications are relatively rare, but can be deadly. ... Read More

FDA warns doctors not to prescribe high doses of Zocor, Vytorin

The Food and Drug Administration (FDA) is advising doctors to use caution when prescribing 80 mg doses of the cholesterol-lowering drug simvastatin, known by the brand name Zocor, because of the risk for muscle injury. Simvastatin is also used in combination with other drugs in Vytorin and Simcor. The 80 mg dose is the highest approved dose available for the drug. The FDA says that this dose should only be used by patients who have been taking it for 12 months or longer without any problems. Doctors who find that their patients taking 40 mg of simvastatin are not meeting ... Read More

FDA warns of link between cholesterol drug, muscle injury

More bad news for the cholesterol-lowering drug Vytorin. The drug has been under scrutiny lately for everything from elevated cancer risk and serious side effects to ineffectiveness. This week, the Food and Drug Administration (FDA) issued a safety announcement about simvastatin, one of the two active ingredients found in the medication, and an increased risk of a potentially life-threatening muscle injury. Vytorin combines simvastatin (sold as in individual ingredient under the brand name Zocor) and ezetimibe (also known as Zetia) to reduce the production of “bad” cholesterol. An FDA review of data from clinical studies, adverse event reports, and prescription ... Read More

High doses of cholesterol-lowering drug linked to risk of muscle injury

People who take the highest dose of a cholesterol-lowering medication simvastatin are at an increased risk of muscle injury, according to the Food and Drug Administration (FDA). The agency made the announcement following a review of data from a large clinical trial as well as other sources. Simvastatin is sold as a single-ingredient generic medication, under the brand-name Zocor, and in combination with esetimibe as Vytorin, and niacin as Simcor. The data came partially from the Study of the Effectiveness of Additional Reductions in Cholesterol and Homocysteine (SEARCH) clinical trial. Other data came from other clinical trials, observational studies, adverse ... Read More