FDA Warns Patients That Cholesterol Drug Zocor Can Cause Muscle Damage
The FDA issued a warning to patients that Zocor (simvastatin) can cause muscle injury, or myopathy, to those who take the drug at its highest approved dose. Zocor, a statin drug, is used to control cholesterol levels and to prevent cardiovascular disease. Simvastatin is sold as on its own as Zocor or in generic form, as well as in combination with ezetimibe as Vytorin and with niacin as Simcor. Since Zocor has been a popular drug for over two decades, as a pharmaceutical liability attorney, many people could have experienced the more severe forms of myopathy that the FDA is warning us about.
The FDA's statement pointed out that "Although muscle injury ... is a known side effect with all statins, the 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, the most serious kind of myopathy, involves the breakdown of muscle fibers and release of the protein pigment myoglobin into the bloodstream. It often can result in severe kidney damage, kidney failure, and even death. People suffering from this condition can also experience weakness, fatigue, joint pain, seizures, and weight gain. The FDA advises patients not to stop taking Zocor unless their doctors advise them to, and to talk to their doctors if they have questions.
The data that the FDA considered in issuing this warning also calls into question whether Zocor is more likely than other statins to cause muscle injury. Simvastatin has been on the market since the late 1980s, so it is somewhat surprising that it has taken this long for the FDA to recognize the seriousness of the problems Zocor can cause. In fact, the statin Baycol (cerivastatin) was withdrawn from the market in 2001 precisely because it was found to carry an extremely high risk of rhabdomylosis -- up to 80% higher than other statins. Before its U.S. patent expired in 2006, Zocor was Merck's best selling drug, and the second-best selling cholesterol-lowering drug in the world, netting $4.3 billion in sales in 2005. Since then, Merck has tried hard to avoid losing its share of the Zocor market to generics, lowering the price for brand-name Zocor so that it could compete with the generics. As a drug defect lawyer, I wonder if Merck knew about these problems, but didn't want to jeopardize the huge profits Zocor brought in while it was still under patent. After all, it was the FDA that brought the muscle injury risk to the public's attention -- not Merck.
The FDA says that rhabdomyolysis is a rare adverse effect of Zocor. But those patients who do develop the condition will have to contend with not just their original heart and cholesterol problems, but painful and debilitating muscle and kidney problems as well. In extreme cases, kidney failure from rhabdomyolysis could mean death or a need for a kidney transplant. If Merck was aware before now of the problems with higher dosages of Zocor, but neglected to warn the FDA and the public, patients who have been adversely affected by the drug could hold Merck legally responsible. Drug manufacturers have a responsibility to warn doctors and patients of adverse effects that their drugs cause. When they fail to do so, the law makes them responsible for all of the injuries to patients that result. This includes all of patients’ medical costs as well as the personal cost of a new and permanent disability.
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