High Dose Statin Limited in US Due to Muscle Damage
The U.S. Food and Drug Administration (FDA) has recommended limiting high doses of a widely prescribed cholesterol lowering drug called simvastatin (commonly known as Zocor).
This decision comes after the FDA evaluated the results of a clinical trial that found a higher risk of muscle damage in patients taking high doses of the statin compared to patients taking lower doses.
On Wednesday the FDA warned that the highest approved dose of Zocor (80mg) can harm muscles and potentially cause deadly kidney damage.
Although over forty-six million Americans take statins, the new recommendation applies only to what the FDA estimates to be 2 million Americans who in 2010 were prescribed 80 milligram doses of simvastatin in one form or another.
The most common side effects of Zocor include muscle pain, tenderness and weakness.
While somewhat rare, the drug can also cause more serious side effects like muscle damage that can lead to liver disease and kidney failure.
Five out of every 100,000 people taking Zocor for a year experienced the “more serious” effects, according to the FDA.
Statins, including Zocor, have been shown to lower cholesterol in patients but many doctors say they’ve known long before this warning of its potential dangers.
Also, according to many healthcare professionals, the FDA recommendation for a warning label is a necessary next step.
“It’s about time,” said Lynn Willis, professor of the department of pharmacology at Indiana University School of Medicine in Indianapolis.
“I’m of the view that the muscle pain induced by Zocor occurs with much greater frequency than we would think.”
Dr. Steven Nissen, chairman of the department of cardiovascular medicine at Cleveland Clinic referenced an editorial he wrote for the Journal of the American Medical Association in 2004 citing potential dangers of the high dose medication.
“It takes the FDA a long time to make these decisions,” said Nissen. “Unfortunately it takes time to sort through the evidence.”
More than 20 million prescriptions are written in Australia each yearfor statin drugs. Statin drugs are a class of drugs that are reputed for lowering the level of cholesterol in the blood by reducing the production of cholesterol by the liver.
- Irritability and short tempers
- Homicidal impulses
- Rapid loss of mental clarity
- Kidney failure
- Muscle aching/weakness
- Tingling or cramping in legs
- Impaired muscle formation
- Nerve damage
- Mental confusion
- Liver damage and abnormalities
- Destruction of CoQ10 levels
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