PFPC Daily - March 11, 2005

FDA warns AstraZeneca on Crestor again

Seattle Post Intelligencer, March 11, 2005

By THERESA AGOVINO

NEW YORK -- AstraZeneca PLC has received its second warning in four
months from the U.S. Food and Drug Administration over what the
agency says are misleading claims in its ads for cholesterol-lowering
medicine Crestor.

The latest letter, which was received in the last few days, said
claims that Crestor lowers cholesterol better than Pfizer Inc.'s
market leading medicine Lipitor are misleading because it cherry
picks results from a study comparing the two medicines.

The information was reported on Forbes.com Friday.

The ads, which feature Dr.-Suess-like rhymes, were taken off the
market in December. A company spokeswoman said Friday AstraZeneca
believed the statements were presented appropriately, but takes the
letter very seriously.

Another spokeswoman Kelly Caldwell declined to comment if the company
would resume the campaign.

The company received a letter from the FDA last December over print
ads it ran which said the agency confirmed the safety and efficacy of
Crestor. Those ads were a response to statements made by FDA official
Dr. David Graham, who said that Crestor was one of five drugs that
should either be taken off the market or have its sales severely
restricted. It was a one-time ad campaign.

Consumer advocacy group Public Citizen has asked the FDA to take the
drug off the market because it says it causes serious health
problems, including rhabdomyolysis, a severe muscle weakness
condition.

Earlier this month, Crestor labels added a warning that starter doses
should be reduced in Asian-Americans and some other patients.

A clinical trial found that levels of Crestor in patients with Asian
heritage were double those of Caucasians taking the same dose,
increasing the chance of muscle damage.

AstraZeneca rose 43 cents, or 1 percent, to close at $42.12 on Friday
on the New York Stock Exchange.