Date:   12/23/2004 7:24:00 AM ( 20 y ago)
Hits:   4,318
URL:   https://www.curezone.org/forums/fm.asp?i=586793

just the tip with the statins. I always hated that commercial...


FDA requires Crestor ads be pulled
Misleading claims of safety are cited
By Diedtra Henderson, Globe Staff | December 23, 2004

Newspaper advertising by a manufacturer that defended the cholesterol-lowering drug Crestor made "false or misleading safety claims," the government said in a letter released yesterday that requires the ads to be pulled.

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AstraZeneca LP, the US arm of the London-based manufacturer, began the national advertising campaign after Food and Drug Administration whistle-blower David Graham named Crestor among five unsafe drugs the agency failed to yank from the market.

"You can be assured that at AstraZeneca, patient safety is our number one priority," began ads that ran Nov. 23 to Nov. 29 in such publications as the Los Angeles Times, The New York Times, USA Today, The Wall Street Journal, and The Washington Post.

The print advertising added, in bold type, that the "FDA has confidence in the safety and efficacy of Crestor." According to the ad, FDA scientists responsible for drug approval "publicly confirmed that Crestor is safe and effective."

In a letter posted on the FDA's website, the agency called that suggestion misleading. The letter quoted from an interview with Dr. Steven Galson, acting director of the FDA's Center for Drug Evaluation and Research,, saying the FDA "has been very concerned about Crestor since the day it was approved."

The letter requires a written reply from AstraZeneca by Jan. 7.

"We really felt it was necessary to try to set the record straight," Emily Denney, an AstraZeneca spokeswoman, said of the ad. "We actually aren't running that ad any longer."

The Washington-based consumer advocacy group Public Citizen pressed the FDA on Nov. 24 to stop the ads. Denney said the company informed the FDA on Dec. 2 that the ad campaign had ended.

More than 12 million Crestor prescriptions have been written to more than 3.5 million patients around the world, according to the company. AstraZeneca was relying on those profits, since its new drug Iressa failed to prolong the lives of people with non-small cell lung cancer. The FDA has not said whether it will remove Iressa from the market, but agreed with AstraZeneca's decision to stop advertising Iressa.

Before the FDA approved Crestor on Aug. 12, 2003, clinical trials pointed to serious muscle problems at the 40 milligram dose. The risk of rhabdomyolysis, a breakdown of muscle that spews muscle fiber into the bloodstream, imperiling the kidneys, increased at higher drug doses. When the agency gave the green light for Crestor to be sold to Americans, it asked for three ongoing clinical trials for people taking 40 mg daily doses that included regular checks of kidney health.

Public Citizen has lobbied the FDA to pull Crestor from the market, saying it is linked to higher rates of severe side effects than such competing treatments as Lescol, Lipitor, Mevacor, Pravachol and Zocor. Analyzing FDA records, Public Citizen found 6.4 cases of serious kidney problems per million Crestor prescriptions, vs. 0.085 cases per million of the rival drug prescriptions.

Sidney Wolfe, director of Public Citizen's health research group, renewed its call to pull Crestor from the market.

The FDA letter said the agency is unaware of evidence that all doses of Crestor are as safe as other comparable products, which "lends enormous fuel to the fire in getting this drug banned," Wolfe said. "Why is the drug on the market?"

Diedtra Henderson can be reached at dhenderson@globe.com.

© Copyright 2004 Globe Newspaper Company.

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