The Food and Drug Administration (FDA) ruled that the controversial
cholesterol drug Crestor does not increase the risk of muscle damage
more than other cholesterol drugs, despite a report by advocacy
group Public Citizen that found otherwise.
Public Citizen, who submitted a petition to the FDA to withdraw
the drug from the market, analyzed data from the FDA's adverse event
reporting system (AERs) that covered from October 1, 2003 to September
30, 2004. The analysis showed the rate of reports of life-threatening
muscle damage, called rhabdomyolysis, from taking Crestor was 6.2
times higher than the rate for all other statins combined (13.1
reports per million prescriptions versus 2.1 reports per million
prescriptions, respectively).
The group also found that AERs reports show an increased rate of
acute renal toxicity, or serious kidney damage, with Crestor as
compared to other statins. According to Public Citizen, before Crestor
was approved one FDA medical officer was so concerned about this
possibility that he said the drug would pose an "unacceptable
risk because other currently approved statins do not have similar
renal effects."
The FDA rejected the group's arguments, saying Crestor does not
pose a greater risk of muscle damage, and there is "no convincing
evidence" that it could cause serious kidney damage. They based
their decision on their own review of AERs reports along with ongoing
clinical trials and safety data that have surfaced since Crestor
hit the market.
Other groups have also criticized the drug. The Lancet, a British
medical journal, reportedly criticized AstraZeneca's marketing efforts
and the FDA sent the drug maker two letters warning that Crestor's
ads were misleading. Further, an FDA scientist told Congress in
November 2004 that Crestor was one of five drugs that "warranted
further safety study."
Crestor was the first cholesterol drug released after Baycol, another
cholesterol drug, was pulled from the market in 2001 because it
caused severe damage to muscles.
AstraZeneca was pleased with the FDA's decision--in 2004, Crestor
brought in $908 million in worldwide sales ($608 million in the
United States alone).
USA
Today March 14, 2005
PublicCitizen.org
March 10, 2005
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