2014: The Year the FDA Said No to a Black Box for Statins

Washington, DCThe start of a new year gives pause to look back at the year that was, and the various stories and issues relating to pharmaceutical drugs and medical products that defined 2014. One defining moment that almost flew under the radar occurred in June, when the US Food and Drug Administration (FDA) rejected the call for a black box warning for statin drugs. Crestor is amongst those statins, and Crestor side effects are among those identified with those of other competing statins by a well-known health watchdog in petitioning the FDA to implement the black box warning.

The watchdog here is Public Citizen. It petitioned the FDA years ago to issue a black box warning for rhabdomyolysis amongst statins. Crestor is amongst those which carry a slight risk for Crestor rhabdomyolysis, a rare myopathy issue characterized by the breakdown of muscle tissue and the absorption of that tissue into the bloodstream. The health implications have the potential to be dire, and rhabdomyolysis has been known to be fatal.

Other Crestor issues include general muscle soreness and the potential for Crestor diabetes.

Public Citizen was initially concerned in 2001; at about the same time that Bayer AG pulled Baycol (cerivastatin) from the market. Dozens of Baycol patients died from complications arising from rhabdomyolysis through their use of Baycol (lawsuits over Baycol had Bayer tied up in litigation for years…). Public Citizen called for a black box warning for all statin drugs at that time.

Finally, in 2014 - thirteen years after filing its petition with the FDA - Public Citizen got its answer…

No.

Slapping a black box warning on all statin drugs would potentially drive patients away from a drug that has long been associated with the lowering of LDL cholesterol, the so-called “bad cholesterol” that can foster the buildup of harmful arterial plaque, leading to heart disease, the FDA surmised. What’s more, various studies and observational investigations have concluded that the risk for rhabdomyolysis - including Crestor rhabdomyolysis - is not nearly as high as that associated with the former Baycol, which is no longer available.

“In brief, we find that cerivastatin (Baycol) was an outlier in terms of benefit-risk profile and risk of rhabdomyolysis compared to the other marketed statins,” the FDA wrote.

Not that Crestor rhabdomyolysis, and rhabdomyolysis associated with competing statin drugs, isn’t possible. Rhabdomyolysis remains a risk, albeit a small one. All the same, it’s a risk the FDA finds acceptable within the context of a mantra that holds a drug is not unsafe provided its benefits outweigh the risks.

To that end, Crestor side effects, regardless of how serious, are acceptable provided they are rare and the benefits outweigh the risks. Given the FDA’s position, there will be no black box forthcoming for statins.