Washington, DCWhen a patient is prescribed Crestor (rosuvastatin) as a means to regulate cholesterol levels in the blood and to minimize the presence of so-called “bad LDL cholesterol,” there are various Crestor side effects one has to consider; muscle pain, the potential for new-onset diabetes and other Crestor issues, some severe with the majority not so severe.
Crestor rhabdomyolysis is one such side effect that belongs in the severe category. Rhabdomyolysis is associated with myopathy, a condition affecting muscle tissue. With Crestor rhabdomyolysis, muscle tissue breaks down and is absorbed into the bloodstream, potentially affecting the kidneys.
And Crestor isn’t the only culprit. Most statin drugs are affected in one form or another, to various degrees, by such side effects and potential adverse reactions. Baycol, or cerivastatin, a product manufactured by Bayer AG was besieged with reports of patient deaths due to rhabdomyolysis. The consumer advocacy group Public Citizen petitioned the US Food and Drug Administration (FDA), in 2001, to implement a black box warning for rhabdomyolysis on all statin drugs. This came after Baycol had been voluntarily removed from the market by Bayer.
In its lengthy response to Public Citizen, the FDA noted that in its experience other statin drugs, including Crestor, do not carry nearly as a high a risk for rhabdomyolysis - and in Crestor’s case, Crestor rhabdomyolysis - as the deadly Baycol once did.
Here’s the thing. The FDA responded to Public Citizen’s petition this past June - 13 years after Public Citizen issued its petition. While the advocacy group is pleased that its request for a more prominent place on the statin prescribing label for general symptoms of myopathy was eventually adopted by the FDA over time, Public Citizen remains concerned.
Much more concerned. According to comments attributed to Sydney M. Wolfe, the co-founder of Public Citizen, there is more evidence as to the risks of statin drugs - of which Crestor is a part - today, than there was when Public Citizen originally issued its petition in 2001. As well, with Baby Boomers moving through midlife, together with revised medical guidelines suggesting the more widespread use of statin drugs as a preventative therapy against heart disease (as opposed to a response to actual symptoms), use of statin drugs is much more prevalent now than 13 years ago, and is poised to grow even further.
Critics also decry the sluggishness exhibited by the FDA in officially responding to a petition 13 years after it was first issued. Were statin drugs to reveal serious adverse reactions, including Crestor side effects, will it take the FDA just as long to respond? And how many thousands or hundreds of thousands of patients would be affected over the interim?
Would there be a Crestor lawsuit? One would assume so, multiplied many times over…
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