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AstraZeneca Sends Advisory On Crestor

May 18, 2004 | Bloomberg News

AstraZeneca Plc, Europe's second-largest drug maker, said it sent a letter to U.K. doctors reminding them to start patients off with the lowest dose of its cholesterol-lowering treatment Crestor.

The company, which has U.S. headquarters in Fairfax, said it sent the "Dear Doctor" letter after noticing that four cases of rhabdomyolysis, a kind of muscle weakness that can be fatal in severe forms, occurred after patients were started on doses higher than the 10-milligram version. The drug's packaging already instructs doctors to start patients at the lowest dose.

Kirsty Walker, communications manager for Crestor, said the company had noticed that the muscle-weakening cases had occurred because of incorrect dosing. The U.K. regulator, the Medicines and Healthcare products Regulatory Agency, agreed with the company's proposal to remind doctors, she said.

"The MHRA agreed that it was a good idea and so we worked together on the wording," Walker said. "We took the lead in sending it."

Walker said the company doesn't have any plans to issue a similar letter in the U.S.

"Doctors in the U.K. have a tendency to start patients on higher doses of statins," Walker said. "It's a U.K. culture thing at the moment."

AstraZeneca Chief Executive Tom McKillop, 61, is relying on new medications such as Crestor and blood-thinner Exanta to help boost earnings and make up for sinking sales of the company's older ulcer treatment Prilosec. AstraZeneca is increasing spending so Crestor can take on Pfizer Inc.'s cholesterol drug Lipitor, the world's No. 1 drug.

Statins, such as Crestor, have been linked to rhabdomyolysis. Bayer AG, Germany's second-biggest drug and chemical maker, withdrew its statin Baycol in 2001 after it was linked to fatalities.

Crestor itself has faced criticism from the British medical journal Lancet as well as Public Citizen, the consumer advocacy group founded by independent U.S. presidential candidate Ralph Nader. Public Citizen has asked the FDA to withdraw Crestor from the market, and McKillop said last month that sales of the drug were temporarily hurt by the comments.

Because Crestor doesn't yet have an extensive track record outside of clinical trials, doctors may shy away from prescribing the product and will be hesitant to switch patients doing well on a competing statin, analysts have said.

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