Tagged Articles

Simcor 3 articles

FDA withdraws approval of niacin, fenofibric with statins

The Food and Drug Administration (FDA) is withdrawing its approval of niacin extended-release (ER) tablets and fenofibric acid delayed release (DR) capsules with cholesterol-lowering statins, saying that based on the outcome of cardiovascular studies on the medications, the benefits of niacin or fenofibric when taken with statins no longer outweigh the risks. The agency concluded that there is no longer scientific evidence that the drugs, when used with statins, reduce triglyceride levels or increase HDL cholesterol levels resulting in a reduced risk of cardiovascular events. Niacin, also known as vitamin B3 and nicotinic acid, and is often used in patients ... 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

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