Lipitor, Other Statins Don’t Need Black Box For Muscle Injuries, FDA Says

Published on June 26, 2014 by Sandy Liebhard

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U.S. health regulators have rejected a petition to mandate that the labeling for Lipitor and other statin drugs bear a black box warning about their association with serious muscle injuries. The decision by the U.S. Food & Drug Administration (FDA) comes as hundreds of people are pursuing Lipitor lawsuit claims that allege the medication can cause new-onset Type 2 diabetes.

A black box warning is the most serious safety alert that can be placed on the label of a prescription drug. In 2001, Public Citizen, a prominent consumer advocacy group, had called on the FDA to add such a warning to all statin medications regarding a potential risk of rhabdomyolysis. Rhabdomyolysis is a severe form of myopathy, or muscle injury, which can lead to kidney failure, kidney damage and death.

The labeling for Lipitor and other statins already includes less serious warnings regarding such injuries. In rejecting a black box, the FDA said earlier this month that the risk of rhabdomyolysis was “consistently low,” and that more prominent warnings could discourage patients who need the drugs from using statins.

Other Lipitor Side Effects

Muscle injuries are not the only side effects associated with Lipitor. In February 2012, the FDA ordered that warnings regarding an association with Type 2 diabetes be added to all statin labels after a study indicated that post-menopausal women treated with the drugs were more likely to develop the disorder.

Since that label modification was ordered by the FDA, hundreds of Lipitor lawsuits have been filed against Pfizer by plaintiffs who were allegedly harmed by the medication. These claims, most of which are pending in a consolidated litigation underway in U.S District Court, District of South Carolina, allege that Pfizer was aware of the link between Lipitor and diabetes long before the drug’s label was updated, but concealed this risk from the public. The lawsuits also maintain that the warnings added to the Lipitor label in 2012 are still not adequate.

Legal Reviews for Victims of Lipitor

Alleged victims of Lipitor diabetes may be entitled to pursue legal claims against Pfizer to obtain compensation for their pain and suffering. To learn more about the legal avenues that might be available to you, please contact the nationwide law firm of Bernstein Liebhard LLP today. Free case reviews can be obtained by calling.