The U.S. Food and Drug Administration (FDA) has rejected calls for new black box warnings on the labels of Lipitor, Crestor, and other popular statin drugs, warning consumers about the risk of potentially life-threatening kidney problems and muscle injury associated with the medications. In a recent letter sent to the consumer watchdog group Public Citizen, the agency indicated that it was denying a petition filed by the organization in 2001, which called for a rhabdomyolysis muscle injury warning on all cholesterol-lowering medications. If you took a statin drug like Lipitor or Crestor, and you have since suffered from complications like muscle injury or rhabdomyolysis, contact an experienced product liability lawyer today for legal help.
In its letter to Public Citizen, the FDA indicated that it does not see a high enough risk of muscle injury associated with statin drugs to warrant a black box warning, which is the strongest label warning that can be required by the FDA. However, mounting research has linked some of the most popular statin medications, like Lipitor and Crestor, to an increased risk of kidney problems, diabetes and serious muscle injury, known as myopathy. The most severe form of myopathy is rhabdomyolysis, a condition that can lead to severe kidney damage, kidney failure and possibly even death.
In individuals with rhabdomyolysis, the muscle fibers in the body begin to break down, releasing a protein called myoglobin, which can cause damage to the kidneys as they attempt to filter it out of the bloodstream. The most common symptoms of rhabdomyolysis include muscle cramps, stiffness, tenderness, pain or spasms, and the illness is typically reported in patients over 65, or those with renal impairment or uncontrolled hypothyroidism. Unfortunately, the FDA has decided that adding a black box warning about rhabdomyolysis to the labels of Lipitor, Crestor and other statins would scare consumers away from using the medications, which may offer some cholesterol-lowering health benefits.
Public Citizen first called on the FDA to add muscle injury warnings to statin labels in 2001, following reports of dozens of deaths associated with the statin drug Baycol, which has since been recalled by its manufacturer, Bayer. In June 2011, the FDA placed restrictions on the use of 80 mg Zocor, a synthetic statin developed by Merck & Co. that, at the time, was associated with an increased risk of rhabdomyolysis side effects. In the years since, the American Heart Association and the American College of Cardiology have issued new heart guidelines that critics fear could result in more than 13 million Americans not currently using statins being prescribed the potentially dangerous drugs permanently.
In addition to severe muscle injury and rhabdomyolysis, statin medications like Crestor and Lipitor have also been linked to an increased risk of diabetes, and in 2012, the FDA required new diabetes warnings for statin drugs, indicating that users may experience a potential impact on blood sugar levels. If you have been diagnosed with diabetes, kidney damage, rhabdomyolysis, or another serious medical condition you believe to be linked to side effects of Lipitor or Crestor, our consumer advocates at the Consumer Justice Foundation can help. We are dedicated to protecting the rights of consumers harmed by potentially dangerous drugs, and can help put you in touch with a reputable attorney who has experience handling statin side effect claims.