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FDA Shows Dangerous Cowardice in Crestor Announcement

March 2, 2005

FDA Shows Dangerous Cowardice in Crestor Announcement

Statement of Sidney M. Wolfe, MD, Director, Public Citizen’s Health Research Group

Today’s announcement by the U.S. Food and Drug Administration (FDA) concerning revised labeling of the cholesterol-lowering drug Crestor is yet another example of the agency’s dangerous cowardice in failing to adequately protect people in this country from uniquely dangerous prescription drugs. Like statements from AstraZeneca, the FDA’s statement is replete with false and misleading information. Rather than responding in a public health-positive manner to our March 2004 petition and banning this drug, the FDA has done exactly what AstraZeneca wanted with minimal labeling changes and surely has pleased one of the drug companies contributing to the $150 million in drug industry funding that the FDA is receiving this year for drug review.

Since the last supplement to our petition to ban Crestor (submitted in October 2004), which was based on adverse reaction reports through August 26 of last year, there have been an additional 52 U.S. cases of life-threatening muscle damage (rhabdomyolysis) reported to the FDA and an additional 12 U.S. cases of kidney failure or impairment in people not having rhabdomyolysis reported to the agency up to the end of January of this year. The total of such U.S. cases reported since the drug was first marketed in September 2003 is now 117 cases of rhabdomyolysis and 41 cases of kidney failure, both higher than seen with the other currently marketed statins. Because of concerns about the safety of Crestor, several countries, including Germany, Norway and Spain, have not approved the drug.

Although the increased rate of rhabdomyolysis is not as high as that of the now-banned Baycol, the FDA is well aware that the rate is higher than that of the other statins, a fact it covers up by saying the rate is “similar.” The FDA statement also includes other “facts” that are extremely misleading if not false:

FDA Statement: “Data available to date from controlled trials, as well as post-marketing safety information, indicate that the risk of serious muscle damage is similar with Crestor compared to other marketed statins.”

Response: Crestor was the only statin that caused rhabdomyolysis at any dose in clinical trials prior to approval. (The cases occurred at 80 mg, a dosage not approved, but most of the post-marketing cases are occurring at 10 or 20 mg.)

FDA Statement: “Mild, transient proteinuria (or protein in the urine, usually from the tubules), with and without microscopic hematuria (minute amounts of blood in the urine), occurred with Crestor, as it has with other statins, in Crestor’s pre-approval trials.”

Response: Although the FDA admits that with Crestor, “The frequency of occurrence of proteinuria appeared dose-related,” it fails to mention that this dose-related increase in proteinuria and hematuria (blood in the urine) was seen only with Crestor and not with any other statin.

FDA Statement: “In clinical trials with doses from 5 to 40 mg daily, this effect was not associated with renal impairment or renal failure (i.e., damage to the kidneys).”

Response: (from FDA medical officer during the July 2003 FDA hearing on Crestor approval): “These three cases of renal insufficiency of unknown etiology are of concern because they present with a clinical pattern, which is similar to the renal disease seen with rosuvastatin in these clinical trials. … Proteinuria and hematuria could be potentially managed with regular urinalysis screening. However, if they 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.”  (emphasis added)

Rather than being a “Public Health Advisory,” as the announcement is titled, this FDA statement is more like an AstraZeneca Health Advisory. In its inability to serve two masters, the FDA has sided once again with its funders in the drug industry.