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Zocor May Increase Muscle Injury Risk

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The U.S. Food and Drug Administration today warned patients and healthcare providers about the potential for increased risk of muscle injury from the cholesterol-lowering medication Zocor (simvastatin) 80 mg.

Although muscle injury (called myopathy) is a known side effect with all statins, today’s warning highlights the greater risk of developing muscle injury, including rhabdomyolysis, for patients when they are prescribed and use higher doses of this drug. Rhabdomyolysis is the most serious form of myopathy and can lead to severe kidney damage, kidney failure, and sometimes death.

“Review of simvastatin is part of an ongoing FDA effort to evaluate the risk of statin-associated muscle injury and to provide that information to the public as it becomes available,” said Eric Colman, M.D., Deputy Director of FDA’s Division of Metabolism and Endocrinology Products (DMEP). “It’s important for patients and healthcare professionals to consider all the potential risks and known benefits of any drug before deciding on any one therapy or dose of therapy.”

Simvastatin is sold as a single-ingredient generic medication and as the brand-name Zocor. It also is sold in combination with ezetimibe as Vytorin, and in combination with niacin as Simcor.

FDA’s review of new information on the risk of muscle injury is derived from clinical trials, observational studies, adverse event reports, and prescription use data. The agency also is reviewing data from the SEARCH (Study of the Effectiveness of Additional Reductions in Cholesterol and Homocysteine) trial, which evaluated major cardiovascular events, such as heart attack, revascularization and cardiovascular death, in patients taking 80 mg compared to 20 mg of simvastatin. SEARCH also included data on muscle injury in patients taking simvastatin.

FDA is committed to informing the public about its ongoing safety review of drugs and will update the public as soon as the review of simvastatin is complete.

Source: FDA, March 19. 2010

Controversial Recommendation to Consider Statins for Kids with High Cholesterol

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The American Academy of Pediatrics has issued new cholesterol screening and treatment recommendations for children that suggest cholesterol screening, and possible use of statins for certain children.

The policy statement, “Lipid Screening and Cardiovascular Health in Childhood,” recommends cholesterol screening of children and adolescents with a family history of high cholesterol or heart disease. It also recommends screening patients whose family history is unknown or those who have other factors for heart disease including obesity, high blood pressure or diabetes.

The AAP suggests that screening should take place after age two, but no later than age 10. The best method for testing, according to the organization’s policy statement, is a fasting lipid profile. If a child has values within the normal range, testing should be repeated in three to five years.

The American Academy of Pedatrics suggests that for children who are more than eight years old and who have high LDL concentrations, cholesterol-reducing medications should be considered. Younger patients with elevated cholesterol readings should focus on weight reduction and increased activity while receiving nutritional counseling.

The policy statement also recommends the use of reduced-fat dairy products, such as two percent milk, for children as young as one year of age for whom overweight or obesity is a concern.

Source: American Academy of Pediatrics, July 7, 2008

Fighting High Cholesterol

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Atherosclerotic heart disease due to high cholesterol is one of the main causes of fatalities and disabilities around the world. However, following a healthy lifestyle goes a long way in lowering LDL cholesterol and preventing heart problems.

To meet healthy cholesterol level goals, there are step-by-step guidelines outlined by the National Cholesterol Education Project. Following a healthy diet that is low in trans and saturated fats and including exercising in your daily routine is the key. For better results, you can go in for effective medicines available today to accomplish the remaining task.

Low Cholesterol May Increase Cancer Risk

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According to a study in the Journal of the American College of Cardiology, use of cholesterol-lowering drugs or statins may increase the risk of developing cancer in patients.

Statins are commonly prescribed to heart patients because they help in lowering the level of cholesterol in blood.

During the analysis, 13 statin clinical trials were performed on 41,000 patients. The results indicated a higher rate of a newly-diagnosed cancer in low-cholesterol patients than high-cholesterol patients.

Although, in comparison to high cholesterol patients one additional case of cancer was found in low-cholesterol patients, researchers are still not sure about a direct link between statin use and increased cancer risk.