Cholesterol-lowering drug Crestor is dangerous and should be taken off the market, Dr. Sidney Wolfe, director of Public Citizen’s Heath Research Group, wrote in a letter published in this week’s issue of The Lancet.

In the letter, Wolfe, said the U.S. Food and Drug Administration had evidence before approving Crestor that it caused an increased incidence of rhabdomyolysis (severe muscle deterioration). “Yet, the agency approved the drug anyway, believing that this toxicity was limited to an 80-milligram dose that was not approved.”

Crestor was approved despite the fact that agency officials had said that any new anti-cholesterol drug should be approved only it has a comparable or lower risk of rhabdomyolysis than drugs already on the market, Wolfe wrote. However, Wolfe, said records show that patients taking Crestor experience severe muscle deterioration at much higher rates than patients taking other cholesterol lowering drugs. Wolfe also said Crestor is associated with primary kidney failure.

Between the drug’s approval in August 2003 to mid-April, Wolfe said, 18 patients including 11 in the U.S., suffered severe muscle deterioration. In addition, there have been eight reported cases of acute kidney failure and four of kidney insufficiency, according to data obtained from the FDA.

“Most of these patients were using the low 10 milligram dose,” Wolfe wrote.

Since mid-April, the FDA has received reports of more than 20 additional cases of rhabdomyolysis, according to agency sources, Wolfe wrote.

Public Citizen filed a petition with the FDA in March to have the drug taken off the market. The petition is pending. Meanwhile, AstraZeneca has launched a major direct-to-consumer advertising campaign to promote the drug.

(via Public Citizen)