WASHINGTON (AP) - The government approved a cholesterol-lowering drug called Crestor Tuesday, after long debate about the risk of side effects.
Made by AstraZeneca Pharmaceuticals, Crestor is the sixth choice in the popular family of drugs called statins that lower cholesterol and reduce the risk of heart attacks.
The Food and Drug Administration approved Crestor because it may be a little more potent than some competitors, but it comes with some warnings:
-Rare cases of a potentially fatal, muscle-destroying condition called rhabdomyolysis occurred in patients taking higher-than-recommended doses of Crestor. Because seven cases occurred during studies of an 80-milligram dose, the FDA only approved a highest dose of 40 mg - and recommends starting doses as low as 5 or 10 mg. Regardless of the dose used, consult a doctor if muscle aches persist.
Muscle pain and weakness has been associated with other statins, too, but full-fledged rhabdomyolysis is very rare. One other statin, Baycol, was pulled off the market in 2001 after it was linked to more than 40 deaths worldwide from that condition.
-The 80-mg Crestor dose also was linked to a few puzzling cases of kidney abnormalities, including protein and blood leaking into urine. While those kidney problems haven't been seen with lower doses, FDA recommends that doctors consider periodic urine checks, and reduce the dose if patients have abnormal results.
-Like all statins, patients also need regular monitoring for signs of another rare problem, liver damage.
Despite the increased warnings for statins, having another option is important as not everyone gets optimal cholesterol-lowering results from today's drugs, said FDA's Dr. Robert Meyer, who oversaw the agency's evaluation of Crestor.
In one study of 2,200 patients, those taking Crestor saw levels of the so-called "bad cholesterol," the LDL type, drop somewhat more than those given other statins, AstraZeneca said.
On the safety side, "we feel comfortable this will be a very different experience from Baycol," FDA's Meyer said. "This one does seem to have more potency, on a milligram per milligram basis ... It is another choice."
A consumer advocate who had lobbied to block the drug's sale said FDA's own internal analyses showed that simply increasing doses of competing statins could be almost as effective - and argued there's no reason the same side effects that showed up in people taking 80 mg of Crestor won't eventually appear at lower doses, too.
"Don't use this drug," said Dr. Sidney Wolfe of Public Citizen, who prepared to post that advice on his Worst Pills/Best Pills Web site. "It has marginal advantages in terms of effectiveness and two significant disadvantages in terms of safety."
AstraZeneca said Crestor, known chemically as rosuvastatin, will begin selling soon, at prices similar to the leading statin, Lipitor.
