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AstraZeneca's Crestor Not Linked to Patient Death (Update2)

By Carey Sargent

Jan. 26 (Bloomberg) -- AstraZeneca Plc, Europe's third biggest drugmaker, said the doctor treating a patient who died while taking cholesterol reducer Crestor ruled the death was probably caused by an infection rather than a side-effect associated with the medication.

AstraZeneca first reported that the patient, who was taking Crestor along with other drugs including Merck & Co.'s cholesterol reducer Zetia and Wyeth's depression drug Effexor, died earlier this month. The company late yesterday released the doctor's assessment on a Web site relating to Crestor's safety.

Crestor, like all treatments in the so-called statin class, has been linked to rhabdomyolosis, a rare and sometimes fatal condition that causes severe muscle weakness and organ damage. The patient was suffering from this condition at death and AstraZeneca reported the case to regulatory authorities.

``Subsequent clarification from the treating physician of the patient confirmed an overall diagnosis of neuroleptic maligant syndrome'' related to the use of anti-psychotic drugs, the company said on the Web site. ``The most likely cause of death, in the treating physician's opinion, was infection not related'' to Crestor.

Shares rose 10 pence, or 0.5 percent, to 1,902 at the close of trading in London.

The company is counting on Crestor for as much as $4 billion in annual sales. The company says the drug's safety profile is comparable to that of other marketed statins. Bayer AG, Germany's second-biggest drug and chemical maker, withdrew the statin Baycol in 2001 after it was linked to the muscle disorder, and the company has since agreed to pay more than $1 billion to settle about 2,700 lawsuits. Baycol was eventually linked to more than 100 deaths.

Concerns

Last year, Public Citizen, a consumer group that has demanded that Crestor be withdrawn, identified a Crestor patient who developed rhabdomyolysis and later died. The patient's death was subsequently ruled to have been because of a heart attack.

``With over 14 million prescriptions written globally to date, the number of cases of fatal rhabdomyolysis expected on Crestor for it to be in-line with the statin class is eight,'' Deutsche Bank analyst Mark Purcell said in a note to investors. ``Therefore with just one case reported to date most likely linked to neuroleptic use, the incidence of fatal rhabdomyolysis with Crestor is lower than expected for the class.''

Neuroleptics, also known as anti-psychotics, have been associated with neuroleptic maligant syndrome, which results in muscle rigidity and hypothermia and sometimes death. The patient was taking Akzo Nobel NV's depression drug Remeron in addition to Effexor.

Kidney damage was seen in patients during clinical testing of Crestor, although primarily in patients taking an 80-milligram dose, more than the highest dose the company sells.

To contact the reporter on this story: Carey Sargent in London at csargent3@bloomberg.net.

Last Updated: January 26, 2005 11:59 EST

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