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Crestor: Example of Poor FDA Regulation


Crestor (rosuvastatin-cholesterol lowering) is an example of dangerously poor FDA regulation, according to the testimony of Sidney M. Wolfe, MD Director of the Public Citizen’s Health Research Group (HRG), before the Health Subcommittee of the House Energy and Commerce Committee Hearing on Current Issues Related to Medical Liability Reform on February 10, 2005.

Despite the Baycol disaster, and some chemical similarity between Baycol and Crestor, the FDA approved Crestor in August 2003, knowing that prior to approval there had already been 7 cases of rhabdomyolysis in clinical trials, compared to none in clinical trials prior to Baycol’s approval (or that of any other statin), Wolfe stated. In addition to this risk, which AstraZeneca (Crestor’s manufacturer) and the FDA wrote off as limited to the highest (80 mg) dose that was subsequently not approved, the drug also causes unique kidney toxicity, even in people who did not have rhabdomyolysis that can lead to secondary kidney damage. An FDA medical officer reviewing dozens of cases of blood and protein in the urine and several cases of renal insufficiency/renal failure in people using Crestor before approval said “if they [these findings] are the signals for the potential progression to renal failure in a small number of patients, this may represent an unacceptable risk since currently approved statins do not have similar renal effects.” Since Crestor came on the market, there have been more than 100 cases of rhabdomyolysis reported to the FDA, a rate per million prescriptions that is higher than any of the other statins still on the market. In addition, there have been approximately 40 cases of renal failure in people without rhabdomyolysis, a rate approximately 75 times higher per million prescriptions than that of the other statins combined.

Weitz & Luxenberg is no longer accepting new Crestor cases.


see also:

Tufts Study Crestor Side Effects Dangers, Tufts-New England Medical Center Study Press Release
Crestor side effects: Tufts Study: Twice as likely as similar statins.

Side Effects Crestor Side Effects- Learn about the Dangerous Side Effects of Crestor
Crestor Side Effects: Rhabdomyolysis & Kidney Damage - FREE Case Eval

Learn More Crestor Lawyer - Looking For a Crestor Lawyer? FREE Crestor Info
Learn More About AstraZeneca's Crestor from Crestor Lawyers

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