BioCentury
ARTICLE | Politics & Policy

FDA denies request to pull Crestor

March 15, 2005 2:44 AM UTC

FDA has denied Public Citizen's request that to immediately remove from the market Crestor rosuvastatin from AstraZeneca (LSE:AZN; AZN). Public Citizen had asserted that the incidence of rhabdomylyosis and renal failure was higher in patients treated with Crestor than with other statins. FDA said that Crestor does not pose a risk of muscle toxicity greater than that of other approved statins and "there is no compelling evidence that Crestor poses a risk of serious renal injury." FDA's response to Public Citizen is available at http://www.fda.gov/cder/drug/infopage/rosuvastatin/crestor_CP.pdf ...