23 December 2004

FDA asks drugmaker to discontinue ad

The Food and Drug Administration has asked the maker of cholesterol-lowering medication Crestor to stop running an advertisement that makes "false or misleading" claims about the drug's safety.

The FDA's letter to AstraZeneca (AZN) was posted on the agency's Web site Wednesday. (Web link: Read the FDA letter)

  FDA disputes Crestor claims

The Food and Drug Administration says AstraZeneca made false and misleading claims about Crestor's safety in national advertisements last month.

"A medication can be more effective and just as safe." The FDA says this claim minimized the risks of taking a 40 mg dose of Crestor.

"The FDA has confidence in the safety and efficacy of Crestor." The FDA says the statement misleadingly suggests that the agency does not believe that Crestor poses safety concerns.

FDA whistle-blower David Graham, in testimony before a Senate committee Nov. 18, named Crestor as one of five drugs that pose serious safety concerns. Graham said Crestor is the only cholesterol-lowering medication, or statin, that causes acute kidney failure and carries a higher risk of rhabdomyolysis, a potentially life-threatening muscle disorder, than other statins.

In response to Graham's comments, AstraZeneca ran a large ad in national and regional publications, including The Wall Street Journal, The Washington Post, The New York Times and USA TODAY.

"The scientists at the FDA who are responsible for the approval and ongoing review of CRESTOR have, as recently as last Friday (Nov. 19), publicly confirmed that CRESTOR is safe and effective; and that the concerns that have been raised have no medical or scientific basis," the ad stated, citing the FDA Web site.

But in a letter to Mark Szewczak, director of promotional regulatory affairs at AstraZeneca, the FDA's Christine Hemler Smith said there is no such statement on the agency's Web site.

"In fact, recent public statements made by the agency contradict that conclusion," wrote Smith, who monitors direct-to-consumer advertising.

She cited a Nov. 18 Washington Post story in which Steven Galson, acting director of the FDA's drug division, is quoted as saying the agency "has been very concerned about Crestor since the day it was approved, and we've been watching it very carefully."

In an e-mail Wednesday, AstraZeneca spokeswoman Emily Denney said, "The FDA in fact moved to clarify Dr. Graham's testimony in a press release the following day."

In that press release, Galson said, "The five specific drugs that Dr. Graham identified in his oral testimony are currently approved as safe and effective for use in the United States," but he says nothing about Graham's concerns having no medical or scientific basis.

The ad also said, "A medication can be more effective and just as safe," going on to make comparisons with other cholesterol drugs. Smith called that claim misleading because it minimizes the risks of kidney abnormalities and rhabdomyolysis associated with Crestor's 40-milligram dose, the largest on the market, which the FDA says is appropriate only as a last resort for patients with extremely high cholesterol. "FDA is not aware of substantial evidence or substantial clinical experience demonstrating that all doses of Crestor are 'just as safe' as other statins," Smith wrote.

Consumer advocate Sidney Wolfe, director of Public Citizen's Health Research Group, said that statement provides further evidence that the FDA should act on a petition from his organization and ban Crestor.

Denney says AstraZeneca has notified the FDA that it is no longer running the ad, which ran Nov. 23-24 in USA TODAY.

By Rita Rubin
USA TODAY

Search Our Canada Pharmacy Prices

close window