Is simvastatin a high risk medication?

[06-08-2011] The U.S. Food and Drug Administration (FDA) is recommending limiting the use of the highest approved dose of the cholesterol-lowering medication, simvastatin (80 mg) because of increased risk of muscle damage.

Is simvastatin being recalled?

There is no complete Simvastatin Recall from the market. The FDA advised that new patients should not be prescribed the 80mg dosage. Also, patients using 40mg doses of Zocor should not be increased to 80mgs.

What are the dangers of simvastatin?

Very rarely, statins can cause life-threatening muscle damage called rhabdomyolysis (rab-doe-my-OL-ih-sis). Rhabdomyolysis can cause severe muscle pain, liver damage, kidney failure and death. The risk of very serious side effects is extremely low, and calculated in a few cases per million people taking statins.

Does simvastatin have a black box warning?

On 8th June 2011, FDA added another black box warning to the use of high dose simvastatin. Based on the review of randomized clinical trial, Study of the Effectiveness of Additional Reductions in Cholesterol and Homocysteine (SEARCH), FDA recommended limiting the use of high-dose simvastatin.

Has simvastatin been discontinued?

Yesterday the Food and Drug Administration told doctors to stop prescribing the top 80-milligram dose of simvastatin, also known by the brand name Zocor, to new patients because of a heightened risk of muscle pain. This decision will affect millions of patients.

Why has simvastatin been recalled?

Dr Reddy’s Laboratories Inc is recalling numerous lots of ezetimibe and simvastatin tablets because they were manufactured using an excipient found to be out of specification for conductivity, according to the November 10, 2021, US Food and Drug Administration (FDA) Enforcement Report.

Can you lower cholesterol without statins?

Exercise Cardiovascular exercise can help to keep your weight at a healthy range and can also boost your heart health. Walking, jogging, biking, and swimming are all exercises that can help lower cholesterol, especially if you do them three times per week or more.

What is the safest cholesterol medicine to take?

Simvastatin and pravastatin had the best safety profile, according to this review. Overall, the researchers found a 9 percent increased risk of type 2 diabetes in people taking statins.