Crestor Recall Unlikely
At what point do side effects justify the removal of a drug from the US market? There is no easy answer to that question, especially when it involves such a high-profile drug like Crestor. However, mounting reports of Crestor side effects is forcing legal and medical experts alike to consider whether a Crestor recall is in order.
FDA recall focuses on risk-benefit analysis
A Crestor recall would have to first meet with the FDA’s specific criteria for taking such a drastic measure.
For one, the FDA only recalls previously approved drugs after new evidence comes to light shifting a drug’s risk-benefit profile far into the red.
The Darvocet recall of 2010 represents a clear example of this shift. Late last year, new evidence surfaced that Darvocet could cause arrhythmia and fatal heart abnormalities with even recommended use of the drug. Darvocet and other propoxyphene-containing drugs had been on the market for more than half a century before they were abruptly recalled.
More dangerous drugs, such as toxic chemotherapy agents and painkillers far more addictive than Darvocet remain on the market today, and for good reason. Their benefit appears to outweigh their risk to those who are prescribed the drugs.
Similar conclusions have not been drawn regarding the risk of Crestor side effects as compared with the medication’s health benefits.
Crestor recall criteria
How then to gauge whether or not there should be a Crestor recall?
Crestor is one of the most popular prescription drugs in the United States, with millions taking the pill daily to reduce bad cholesterol and stave off heart disease, the number one killer in America.
But there have been numerous reports of Crestor side effects, most notably rhabdomyolysis – a severe kidney disorder that has been implicated in Crestor death – and cardiomyopathy, also known as heart muscle disease.
Severe Crestor side effects may be rare, but they may be particularly deadly when they do occur.
Some doctors do see a lot of Crestor side effects, albeit lesser ones.
Matthew F. Muldoon, an internist and clinical pharmacologist at the University of Pittsburgh Medical Center, told Scientific American in March 2010: “Most clinicians will tell you that they see [statin side effects] in at least 5 percent of patients and as many as 20 percent.”
Status quo: Crestor side effects do not rise to level of Crestor recall
Today, the Crestor side effects and side effects of less strong statins like Lipitor and Zocor that Muldoon refers to are mostly muscle and joint pain. Crestor death and more serious statin side effects occur with far less regularity.
According to some physicians, Crestor death resulting from cardiomyopathy may be prevented by taking supplements containing Coenzyme Q10, also known as CoQ10, a vital heart enzyme that appears to be collateral damage of Crestor use.
Crestor currently remains the strongest statin that anyone can take. A 20 mg dose can reduce LDL (bad cholesterol) by 50-55 percent. By contrast, the same dose of Lipitor, the best-selling pharmaceutical in history, reduces LDL levels by 40-45 percent.
While many believe that Crestor side effects are commensurately more severe than its cousins, it may be some time before the FDA ever takes steps to initiate a Crestor recall. So far, evidence suggests the drug saves far more people than it hurts. Nevertheless, alternatives may be safer.