Pharmaceutical

FDA rejects consumer group’s request for black box warning on statin drugs

lipitor 435x435 FDA rejects consumer groups request for black box warning on statin drugsCholesterol-lowering statin medication will not carry a black box warning for a deadly muscle disorder, the Food and Drug Administration (FDA) announced. The agency was petitioned by the consumer watchdog group Public Citizen, urging the FDA to force drug makers to alert consumers of the risk of rhambdomyolysis, a condition in which muscle cells break down and enter the bloodstream where they can damage the kidneys.

Public Citizen filed its petition in 2001, not long after Bayer pulled its statin drug Baycol (cerivastatin) off the market after mounting reports of patients dying from the condition while taking the medication. The FDA says other statins, such as Lipitor (atorvastatin) and Zocor (simvastatin), do not carry a high enough risk to constitute a black box warning, and adding one to the drugs’ labels may prevent patients from using the drugs.

Public Citizen, however, says that more evidence has emerged about the risks of statins and that it is in the best interest of the public that the FDA adequately warn consumers. The consumer group also asked that statins be dispensed with medication guides and that manufacturers send “dear doctor” letters warning of the risk of rhyambdomyolysis, which the FDA rejected saying neither was necessary.

Furthermore, Public Citizen requested that statin makers give a more prominent warning for myopathy, a milder form of muscle injury related to rhabdomyolysis. The FDA says that request has been “effectively granted” in the past few years.

Statin side effects have resulted in personal injury lawsuits and False Claims Act litigation throughout the years. More recently, lawsuits have been filed alleging statins increase blood sugar levels and put users – especially older women – at risk for type 2 diabetes, a chronic condition that can lead to more serious health conditions.

Source: Law 360