Waxman Requests FDA Investigation of Crestor Advertisements

Rep. Henry Waxman (D-Calif.) on Friday sent a letter to FDA requesting that the agency review allegedly "misleading advertising" by AstraZeneca related to safety concerns for its cholesterol-lowering drug Crestor and order the company to post a correction if the claims are found to be erroneous, USA Today reports (Leinwand, USA Today, 12/9). At a November hearing before the Senate Finance Committee on the recent voluntary withdrawal of Vioxx, a COX-2 inhibitor manufactured by Merck, David Graham, associate director of drug safety in the FDA Office of Drug Safety, said that Crestor and four other prescription drugs present significant safety risks to consumers.

In his testimony, Graham said Crestor is the only cholesterol-lowering medication to cause acute kidney failure and is likely to lead to serious muscle problems. Graham also cited safety concerns about the COX-2 inhibitor Bextra, manufactured by Pfizer; the obesity treatment Meridia, manufactured by Abbott Laboratories; the acne medication Accutane, manufactured by Roche; and the asthma treatment Serevent, manufactured by GlaxoSmithKline (California Healthline, 11/22).

According to USA Today, following Graham's testimony, AstraZeneca responded with full-page advertisements that ran in national and regional publications for two or three days. The advertisements said, "The FDA has confidence in the safety and efficacy of Crestor." In his letter, Waxman said that the advertisements and a statement on the company's Web site saying that FDA officials have "no concern in relation to Crestor's safety" seem to conflict with FDA statements about the drug. He said, "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."

Waxman pointed out that Steven Galson, acting director of FDA's Center for Drug Evaluation and Research, said in one interview that the agency "had been very concerned about Crestor since the day it was approved, and we've been watching it very carefully." USA Today reports that in a written statement following Graham's testimony, Galson also said that Graham's statements do not reflect FDA's views and that all five drugs mentioned in his statement currently are approved as "safe and effective" for use in the United States.

Kathleen Quinn, a spokesperson for FDA, said the agency has received Waxman's letter and "takes his concerns seriously and will respond promptly." AstraZeneca spokesperson Emily Denney defended the company's statements, saying they are "consistent with what has been communicated to us by the FDA." She also said that the advertisements were necessary to correct misinformation given in congressional testimony that resulted in a large number of calls to the company from patients and doctors (USA Today, 12/9).