(10-02) 13:50 PDT WILMINGTON, Del. (AP) --
WellPoint Health Networks, the nation's second-largest private health insurer, says it will not reimburse people who use AstraZeneca's new cholesterol drug, Crestor, because of concerns over its safety and benefits.
The Food and Drug Administration approved Crestor in August after a long debate about the risk of side effects. However, the approval came with warnings about rare cases of a potentially fatal, muscle-destroying condition that effects the kidneys called rhabdomyolysis, which occurred in patients taking higher-than-recommended doses of Crestor.
After seven cases of rhabdomyolysis occurred during studies of the 80-milligram dose for which AstraZeneca initially sought approval, the FDA approved a maximum dose of 40 mg and recommended starting doses as low as 5 or 10 milligrams.
High doses of Crestor also were linked to a few puzzling cases of kidney abnormalities, including protein and blood leaking into urine.
And as with other cholesterol drugs known as statins, Crestor also poses a risk of liver damage.
"There is a level of nervousness, and we're being conservative and we're being cautious," said Dr. Robert Seidman, chief pharmacy officer for Thousand Oaks, Calif.-based WellPoint.
Seidman noted past problems with Baycol, a statin formerly manufactured by German drug maker Bayer AG. Bayer stopped selling the drug in 2001 and it was eventually linked it to more than 100 deaths.
Roger Hyde, director of AstraZeneca's Crestor business, said he wasn't aware of WellPoint's decision and wouldn't comment on it.
But London-based AstraZeneca, which has its U.S. headquarters in Delaware said Crestor is safe.
Excluding people who have taken the drug in clinical trials, 200,000 patients have used Crestor in 13 countries, beginning with Canada last February, Hyde said. Spokesman Gary Bruell said the company knows of no cases of kidney damage or contributing conditions among those patients. The company will soon offer the drug in 17 more countries.
Some private insurers have said they will reimburse for Crestor, while others are still deciding. State Medicaid programs have said they will pay for the drug.
Crestor's advantage over other statins is that it is more potent, one reason the FDA concluded that its benefits outweighed the risks.
WellPoint's Seidman said Crestor's strength is potentially hazardous, because doctors accustomed to prescribing weaker statins could switch patients to the same dosage of Crestor.
Consumer advocate Ralph Nader's watchdog group, Public Citizen, issued a "do not use" warning for Crestor last month. The group's top medical expert, Dr. Sidney M. Wolfe, called the drug "possibly worse than Baycol" and predicted that Crestor also likely will be withdrawn from the market.
AstraZeneca shares closed up 22 cents to $44.32 on the New York Stock Exchange.
