What Are the Risks of Statin Side Effects?

Washington, DCWhile Crestor side effects concerns have been raised by a public advocacy group, and lawsuits have been filed alleging patients suffered severe health problems after using statin drugs such as Lipitor, a major journal is considering the fall-out from a highly controversial study that may have overstated the risk of statin side effects. Among concerns about Crestor side effects, as with other statin drugs, is a reported increased risk of developing diabetes.

Two studies, published in BMJ in October 2013, reportedly overstated the incidence of adverse reactions to statins. The problem, Forbes (5/14/14) reports, is that both papers improperly cited a previous paper, which resulted in an overstatement of the incidence of adverse events.

Initially, BMJ and the studies’ authors wrote a correction, which for one study kept the incidence of adverse reactions at “substantially higher than the 5% to 10% percent usually described in randomized, placebo-controlled trials,” but noted that the study they cited was uncontrolled and may be inflated.

BMJ had published an editorial noting that the adverse incident figure of 18 to 20 percent was based on statements in an observational study and did not take into account important caveats to the study. Therefore, statements suggesting adverse events occurred in 18 to 20 percent of patients were withdrawn. At the time, the editor-in-chief, Fiona Goodlee, noted that the incorrect statements were secondary to the primary focus of the articles and as such, the full articles should not be retracted.

Now, BMJ is convening an independent expert panel to determine whether the articles should be fully retracted.

Crestor is classified as a statin and is used to lower high cholesterol. In 2004, public advocacy group Public Citizen petitioned the FDA to ban Crestor (known generically as rosuvastatin) because of concerns about side effects. In its letter, Public Citizen cited seven cases of life-threatening rhabdomyolysis and nine cases of kidney failure or kidney damage linked to Crestor.

At the time Public Citizen wrote its petition, the organization noted that Crestor had only been on the market for just more than five months.

In February 2012, the FDA expanded its advice about statin risks to include the potential for muscle damage (myopathy), a small increased risk of diabetes and rare liver injury.

Lawsuits have been filed against Pfizer, maker of another statin called Lipitor, alleging patients suffered severe health problems as a result of using the statin.