FDA Puts Strict Limits on High Dose Zocor

Simvastatin is the generic name for the widely-popular anti-cholesterol drug Zocor, which is prescribed in doses ranging from 10-80 milligrams (mg).  Drugs that also contain Simvastatin include Vytorin and Simcor.  

The FDA estimates that 1.2 million Americans are currently taking the 80 mg dose of Simvastatin. The FDA has been studying this drug for some seven years.  The study compared patients taking the 20 mg dose versus those taking the 80 mg dose.  Of those participating in the study, 52 people suffered from myopathy, which is another word for muscle weakness. In rare cases, myopathy can progress to rhabdomyalsis, which can permanently damage the kidneys and lead to potentially fatal kidney failure.

The FDA recommends that doctors not write any new prescriptions for the 80 mg dosage and has placed strict restrictions on the circumstances under which those currently taking 80 mgs should continue.

Anyone who is taking Simvastatin and is currently experiencing muscle pain or weakness, dark or red urine, or unexplained fatigue should contact his/her healthcare provider immediately.

If you or a loved one has suffered from muscle damage or deterioration while on Simvastatin, contact Van Wey Law today.