Nationwide ZOCOR® Law Firm
Simvastatin, a hypolipidemic drug used to control cholesterol levels, was originally marketed by Merck & Co. under the trade name ZOCOR® and has now been linked to serious health concerns. ZOCOR® became Merck's highest grossing product, having sales of over $4.3 billion in 2005 alone. In June 2006 simvastatin became generic and has been sold by a number of different pharmaceutical companies. It is also sold in combination with other drugs under the trade names VYTORIN® (combined with ezetimibe), and SIMCOR® (combined with niacin).
SIMVASTATIN/ZOCOR LINKED TO MUSCLE AND KIDNEY INJURIES
On March 19, 2010 the FDA issued a news release warning patients and healthcare providers of the dangers of taking the highest approved dose (80-mg) of ZOCOR®. After analyzing data from the Study of the Effectiveness of Additional Reductions in Cholesterol and Homocysteine (SEARCH) trial, the FDA determined that patients taking ZOCOR® were at a higher risk for injuries including:
- Muscle Injury
- Myopathy
- Muscle Pain
- Rhabdomyolysis (breakdown of muscle fibers and the release of harmful chemicals into the bloodstream)
- Kidney Damage
- Kidney Failure
- Death
The FDA requested that the manufacturers of simvastatin change the product labeling to instruct doctors to limit prescriptions to 40-mg or less in combination with some medications. However, a recent review of prescription drug use data by the FDA found that despite those label changes, higher doses of simvastatin were still being prescribed in combination with medications known to exacerbate adverse side effects.
THE FDA MANDATES NEW WARNINGS FOR SIMVASTATIN/ZOCOR
In June of this year the FDA recommended further limiting prescriptions of 80-mg simvastatin. It determined that the 80-mg dose should only be prescribed to patients who have been taking that dose "chronically" (i.e., for 12 months or more) without evidence of muscle injury. The FDA came to the conclusion that the drug warnings needed to be modified after analyzing updated data from the SEARCH trial. It found that 52 patients in the 80-mg group versus one patient in the 20-mg group developed myopathy and 22 patients in the 80-mg group versus zero in the 20-mg group developed Rhabdomyolysis.
If you or a loved one has taken simvastatin or simvastatin-containing drugs and suffered muscular damage or kidney problems you may be entitled to compensation. Please contact the attorneys at Aaron M. Levine & Associates for your free case consultation.
