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…
READ MORE CRESTOR LEGAL NEWS
“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.