ASTRAZENECA was again forced to mount a robust defence of the safety of its Crestor cholesterol-lowering drug yesterday, after it emerged that the treatment had been linked to a third fatality.

In a statement, the Anglo-Swedish drugmaker confirmed that Crestor had been listed as a possible cause of death in a patient suffering from rhabdomyolysis, a muscle-wasting disease, late last year.

The company said that the details surrounding the death were “complex”, and added that the patient was taking other medication that might have caused a condition known as neuroleptic malignant syndrome.

AstraZeneca emphasised that regulators around the world had been notified of the death and that the case had been included in data on a company website. A spokesman insisted that the company remained happy with the safety profile of the drug.

However, the news will raise fresh doubts over the long-term future of Crestor. The drug, on which AstraZeneca is relying heavily to boost profit growth, has been dogged by safety fears.

In November a leading official in the US Food and Drug Administration said that there was an urgent need to investigate the links between Crestor and rhabdomyolysis. The FDA later tried to distance itself from the official’s comments, but reacted furiously when AstraZeneca tried to capitalise on the move with a series of newspaper adverts in which it claimed that the agency had “confidence in the safety” of the drug.

The FDA later wrote to the company, complaining that the advert “misleadingly” suggested that regulators believed there were no safety concerns associated with the medicine.

A link between rhabdomyolysis and a family of heart drugs known as statins, to which Crestor belongs, is well documented. In August 2001 Bayer, of Germany, was forced to withdraw its cholesterol-lowering drug, Baycol, from the market after clinical tests linked it to the deaths of more than 30 patients suffering from the muscle-wasting disease.

Bayer has since spent more than $1.1 billion (£590 million) settling claims with more than 1,600 patients who suffered side-effects after taking Baycol.

In June last year European regulators ordered AstraZeneca to lower the dosage of Crestor as patients began to contract rhabdomyolysis.

AstraZeneca insisted last night that the circumstances surrounding Crestor were different to those for Baycol. The company said that it had experienced just one rhabdomyolysis-related death despite writing more than 14 million prescriptions to four million patients. Baycol, on the other hand, was associated with more than 30 deaths among a patient population which had received 10 million prescriptions. Of the two other Crestor-related deaths, one was linked to a heart attack while the other remained unresolved, the company said.

The latest case marks the first suspected instance in which a fatality from rhabdomyolysis has been linked to Crestor.

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