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Jurdys Blog Monheit Law : Blog Home : 2004-12-09 : Article

Crestor is under fire for AstraZeneca's advertisement claims

by Michael Monheit, Esquire, Monheit Law, PC













The FDA has been requested by a House Democrat to investigate the claims being made by AstraZeneca. The claims being pressed by Rep. Henry Waxman (D) of California are that AstraZeneca claims that the FDA is confident that Crestor is "safe and effective." However, that claim flies in the face of testimony from Dr. David Graham, and FDA safety officer, who named Crestor as a drug that is potentially hazardous .


In response to Dr. Graham's testimony, AstraZeneca took out full page ads in major newspapers, including the NY Times, Wall Street Journal, Washington Post and USA TODAY. Accoridng to Waxman, "Either AstraZeneca is misleading the public about Crestor's safety, or FDA officials are giving the company private assurances that conflict with the agency's public position."


Even Steve Galson, acting director of the FDA Center for Drug Evaluation and Research said that the FDA "had been very concerned about Crestor since the day it was approved, and we've been watching it very carefully."


The FDA has issued a safety warning about Crestor as a result of label changes in Europe that warn about the risk of developing Rhabdomyolysis (a sever and painful muscle disorder) from Crestor.




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