CHOLESTEROL-LOWERING DRUGS Analysis: Crestor's side effects worse than those of competitors



Risk of serious problems with all of the drugs is still very low.
DALLAS (AP) -- Contrary to government claims, side effects happen more often with Crestor, a cholesterol-lowering drug that consumer advocates tried to get off the market earlier this year, a new analysis shows.
The review of leading cholesterol drugs taken by millions of Americans showed that most are very safe and that the risk of serious problems, even with Crestor, is very low. But the latest research seemed to challenge a Food and Drug Administration decision related to the drug's safety.
In March, the FDA had contended Crestor's risks were no greater than its competitors, and it rejected consumer efforts to have the drug, made by AstraZeneca PLC, pulled from the market.
Instead, the FDA ordered a warning on the label, saying Crestor could cause serious muscle problems and kidney damage, especially among Asians.
FDA spokeswoman Laura Alvey said that the new analysis yielded no new information. "We haven't found any convincing evidence that Crestor poses any more of a risk than the other statins," she said.
The new study, based on reports of side effects reported to the FDA, said that kidney problems and severe muscle weakness were two to eight times more frequent among Crestor users than those taking other statins.
"This will be further reason to take the drug off the market," said Dr. Sidney Wolfe, director of the consumer group Public Citizen. He said his group would try again to get sales halted.
The drug's maker, AstraZeneca, said the higher reports of side effects may have been the result of heightened awareness of the problems with another cholesterol drug, Baycol, which was pulled from the market in 2001.