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More information on rosuvastatin (Crestor)

Letter Demonstrating that Rosuvastatin (Crestor) Has Higher Rates of Rhabdomyolysis Compared to Other Statins

March 10, 2005

Lester Crawford, DVM, Acting Commissioner
Food and Drug Administration
5600 Fishers Lane
Rockville, MD  20854

Dear Dr. Crawford,

FDA’s statement last week — accompanying the announcement of new warnings on AstraZeneca’s cholesterol-lowering drug Crestor — that “the risk of serious muscle damage is similar with Crestor compared to other marketed statins” is strongly refuted by the most recent comparative data from the FDA’s own adverse event reporting system (AERs).

This week, we finished analyzing latest data on rhabdomyolysis (life-threatening muscle destruction) reports for Crestor and the other marketed statins.  The data covered the period from October 1, 2003 through September 30, 2004 (the latest date for which such comparative data are available), and our analysis adjusted for the relative numbers of prescriptions filled for the different statins (see table on the following page). We found that the rate of reports of rhabdomyolysis sent to the FDA per million prescriptions filled for Crestor (13.1 reports per million prescriptions) is 6.2 times higher than the rate for all of the other statins combined (2.1 reports per million prescriptions filled). The comparison between Crestor and the statin with the lowest rate of rhabdomyolysis reports (Pravachol, 0.6 reports per million prescriptions) shows Crestor to have a rate 21.8 times higher than this statin. Even compared to the rate of the statin having the second highest rate of reports (Zocor/simvastatin), Crestor is 2.8 times higher.

These data affirm the pre-approval findings from clinical trials of increased muscle damage/rhabdomyolysis for Crestor compared with the other statins and refute the FDA statement that the rates are “similar”.

The new data comparisons--showing a uniquely higher rate of this life-threatening adverse effect for Crestor than for other statins--need to be considered in conjunction with our earlier analysis showing that the rate of acute renal failure reports in people not having rhabdomyolysis was 75 times higher for Crestor than for the other statins combined.  (See our letter to you of October 29, 2004).

Merely rubber-stamping the AstraZeneca-derived label change as the FDA did last week is not an acceptable way for the agency to regain its credibility concerning drug safety protections, credibility that has come under such well-deserved but delayed scrutiny in the past several months. The record shows that the FDA waited for a deadly, patient-damaging year between its realization of an increased rate of rhabdomyolysis reports for Baycol (cerivastatin) compared to other statins and the belated banning of that drug in August 2001.

For Crestor, unlike Baycol, the AERs show not only the increased rate of rhabdomyolysis reports but, as mentioned above, unique acute renal toxicity. Prior to Crestor’s approval, an FDA medical officer was so concerned about the large number of Crestor patients experiencing a dose-related increase in acute kidney damage manifested by blood and protein in the urine and not seen with any other statins that he stated that if the urine blood and protein was accompanied by cases of acute renal failure, it would constitute an “unacceptable risk because other currently approved statins do not have similar renal effects.”

This letter supplements our original petition to ban Crestor filed one year ago in March 2004 and the supplement to that petition filed last October. We again strongly urge you to immediately ban this drug before it does further damage to patients in this country.

Comparative Rates of Rhabdomyolysis Reports to FDA

Drug

Rhabdomyolysis reports to FDA (10/1/03-9/30/04)

Rx’s Filled (millions)(10/1/03-9/30/04)

Rhabdomyolysis reports per  million Rx’s

Crestor rate as multiple of other rates

Crestor

68

5.2

13.1

 —

Zocor

139

29.8

4.7

2.8

Mevacor etc*

16

8.0

2.0

6.6

Lipitor

87

66.6

1.3

10.1

Lescol

2

2.1

0.95

13.8

Pravachol

9

15

0.60

21.8

All statins except Crestor

253

121.5

2.1

6.2


*Mevacor is available generically as lovastatin and Altocor

Sincerely,

Sidney M. Wolfe, M.D.
Director
Public Citizen’s Health Research Group

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