AstraZeneca Plc’s cholesterol-reducer Crestor should be pulled from the U.S. market because some patients have experienced kidney damage and muscle destruction, the consumer group Public Citizen said.
The group sent a letter to U.S. Food and Drug Administration Commissioner Mark McClellan asking him to halt Crestor sales. Since the drug won approval in August, three U.S. patients developed kidney failure or muscle damage and one died, said Public Citizen, citing information from the FDA and other health agencies.
“The urgency of this petition is heightened by the fact that AstraZeneca is currently launching a major direct-to consumer advertising campaign to promote the drug,”Public Citizen’s director of health research, Sidney Wolfe, wrote.
More than a dozen products have been pulled from the U.S. market after Public Citizen asked the FDA to withdraw them, including the Rezulin diabetes drug and Redux diet pill, the Washington-based consumer group said.
One 39-year-old woman in the U.S. died while on Crestor, Public Citizen said. Wolfe’s letter also cites cases of complications outside the U.S.
AstraZeneca, the U.K.’s second-largest drugmaker, said in January that total sales of Crestor reached $41 million in its first full quarter on the U.S. market. That was less than half the amount some analysts, including at Credit Suisse First Boston, expected.
“We have been monitoring the safety of the product very carefully,” AstraZeneca Chief Executive Thomas McKillop said in an interview today before Public Citizen’s announcement. “We are absolutely confident that there is no issue of safety. So that is behind us, I think. We have a terrific drug, a very effective drug.”
German drugmaker Bayer AG removed its Baycol, a drug similar to Crestor, from the market worldwide in August 2001, citing increasing reports of side effects involving muscular weakness.
Baycol and Crestor are part of a class of drugs known as statins, which work by hampering the liver’s production of cholesterol.reduce
All statins are associated with rare cases of a breakdown of muscle cells, called rhabdomyolysis. The condition can cause kidney damage and possible death when it overwhelms that organ’s ability to clean up the debris left by dead muscle cells.
The FDA told AstraZeneca in May 2002 that it would need to resolve the agency’s concerns about potential kidney and muscle risk before Crestor sales could begin in the U.S. Crestor’s FDA- approved label mentions abnormal kidney results detected in some patients taking the drug.
Public Citizen, which represents about 160,000 U.S. consumers, in July asked the FDA not to approve Crestor because of its potential for side effects. The FDA will consider Public Citizen’s new request and get back to the group after a review, FDA spokeswoman Laura Bradbard said.
“One million patients have taken Crestor to date worldwide and the post-marketing safety profile mirrors what we have seen in clinical data,” said Chris Major, a spokesman for London-based AstraZeneca.