High Zocor Doses Increase Muscle Injury Risk
The maximum FDA-approved dosage of Zocor significantly increases the risk of muscle injury, according to a recent public safety alert from the drug agency, which recommended a Zocor label change. The chances of developing muscle weakness or damage, a side effect which often leads to a Zocor lawsuit, is highest for patients of Asian descent, but is serious enough for people of all genetic backgrounds that the FDA has recommended that no new patients be prescribed the highest 80mg dose of the cholesterol-lowering statin, also known as simvastatin.
FDA Zocor Label Change
For an experienced Zocor lawyer, this warning may be viewed as a case of “too little, too late,” given that Zocor lawsuit numbers have been steadily growing in number for several years.
The FDA reports that the risk of muscle injury is also increased for patients taking Zocor along with other medications such as amiodarone (used to treat heart arrhythmias), niacin (an anti-cholesterol drug), and diltiazem (a calcium-channel blocker that treats high blood pressure).
Zocor label change comes after clinical study
The FDA’s proposal for a Zocor label change came in response to the findings of a clinical study that examined 12,000 patients taking Zocor. Half of the patients were prescribed the maximum allowed 80mg dose, and half a 20mg dose. In the high dose group, 50 patients developed myopathy, compared to only one patient in the 20mg group. Another result that contributed to the demand for a Zocor label change is the fact that 11 patients taking 80mg doses developed a severe expression of myopathy called rhabdomyolysis, an uncommon condition in which decomposing muscle fibers shed a protein called myoglobin into the bloodstream. When myoglobin reaches the kidneys, whose function is to filter out impurities from the blood, it can cause damage and in some cases total kidney failure. Side effects of rhabdomyolysis include fatigue and blood in the urine. None of the patients in the clinical trial who were on a regimen of 20mg Zocor doses developed rhabdomyolysis.
It is recommended that patients who have suffered from rhabdomyolysis or any of its side effects such as red urine, muscle weakness, or kidney damage contact a Zocor lawyer to discuss the potential for a product liability Zocor lawsuit.
Zocor label change also warns about drug interactions
The FDA’s proposed Zocor label change warns against taking any of the following drugs while also taking even the lowest doses of Zocor: itraconazole, ketoconazole, erythromycin, clarithromycin, telithromycin, and HIV protease inhibitors.
An experienced Zocor lawyer may advise patients that they could be eligible to file a Zocor lawsuit if they have experienced any known Zocor side effects, including not only myopathy and rhabdomyolysis, but also diabetes and the rare, debilitating muscle disorder Guillain-Barre syndrome.