U.S. Group: AstraZeneca Drug Risk Higher Than Others
(10-March-2005/Reuters)
The rate of serious muscle damage reported in patients who took AstraZeneca
Plc's cholesterol drug Crestor was six times higher than with similar medicines,
a consumer group said on Thursday.
The findings by consumer group Public Citizen contradicted a statement by the
U.S. Food and Drug Administration last week that the risks of muscle injury from
Crestor were similar to those of related drugs.
Public Citizen renewed its call for the FDA to immediately ban Crestor, one of a
family of drugs called statins. Millions of people take statins to lower their
cholesterol and reduce the risk of heart disease.
The group said it had reviewed reports of cases of rhabdomyolysis, a life-threatening
muscle breakdown, and compared them with the number of prescriptions filled for
each drug. The reports were submitted to the FDA between Oct. 1, 2003, and Sept.
30, 2004.
For Crestor, there were about 13 reports of rhabdomyolysis for every million
prescriptions filled, Public Citizen estimated. That rate was 6.2 times higher
than the rates for all other statins combined.
The lowest rate among other statins was 0.6 reports per million prescriptions of
Bristol-Myers Squibb's Pravachol.
"These data affirm the pre-approval findings from clinical trials of increased
muscle damage/rhabdomyolysis for Crestor compared with other statins and refute
the FDA statement that the rates are 'similar,"' Public Citizen said in a letter
to acting FDA Commissioner Lester Crawford.
Last week, the FDA said it had completed a review of Crestor's safety and
concluded risks of muscle injury were similar to those of other statins. To
reduce the risk, doctors were advised to consider the lowest possible dose for
certain patients.
AstraZeneca has repeatedly defended Crestor as safe and effective when used
according to directions.
Public Citizen first petitioned the FDA to ban Crestor in March 2004.
Millions of people around the world take statins, including Pfizer Inc's popular
Lipitor-- the world's best-selling drug.
Bayer AG's statin Baycol was pulled from the market in 2001 after it was linked
to more than 100 deaths, many from a severe muscle-damaging condition called
rhabdomyolysis.