Group seeks ban on cholesterol drug
A consumer group Thursday asked the U.S. government to ban an AstraZeneca cholesterol drug approved only months ago, citing reports of dangerous reactions and one death.
The prescription drug, Crestor, was introduced in Canada in February 2003 and in Europe in March 2003. The drug hit the U.S. market last September.
Since the drug’s launch, seven patients who took it developed life-threatening muscle deterioration, and nine experienced kidney failure or damage, consumer group Public Citizen said.
One 39-year-old U.S. woman died from kidney damage and muscle breakdown, a known side effect of drugs such as Crestor called statins, the group said.
The information, detailed in a petition to the Food and Drug Administration, was based on reports submitted to regulators in the United States, Canada and Britain, Public Citizen said.
“For there to have been that many of those problems in basically in less than a year is very worrisome,” Dr. Sidney Wolfe, head of Public Citizen’s Health Research Group, said in an interview.
Cases of muscle breakdown, known as rhabdomyolysis, led to the 2001 withdrawal of Bayer AG’s Baycol, which was linked to more than 100 deaths.
AstraZeneca is relying on Crestor, known generically as rosuvastatin, to drive future profits. Millions of people take statins to lower high cholesterol, a major risk factor for heart disease.
More than 1 million patients have taken Crestor, AstraZeneca spokesman Gary Bruell said. Side effects so far ”totally mirror the experience” in the company’s clinical trials that supported Crestor’s approval, he said.
The drug’s risks “are comparable to other statins,” he said.
While both the muscle and kidney problems were seen in premarketing trials of Crestor, the FDA concluded the drug’s benefits outweighed its risks at doses of five to 40 milligrams. Safety concerns had led AstraZeneca to drop plans to market an 80-milligram dose.
Public Citizen, which had urged the FDA not to approve Crestor in the first place, said the post-marketing information showed serious side effects occurred even in patients taking the lower doses.
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