Take ‘doomed’ cholesterol drug off the market, urges expert

A NEW cholesterol-lowering drug launched last year should be taken off the market because of its poor safety record, an expert said yesterday.

Writing in The Lancet medical journal, Dr Sidney Wolfe said the statin drug Crestor was "ultimately doomed".

The drug has been linked to a condition called rhabdomyolysis, a breakdown of muscle fibre which can cause kidney failure.

The disorder is a recognised but rare side effect of this class of drug. However, both data shows higher rates of rhabdomyolysis associated with Crestor than with other statins, says Dr Wolfe.

Dr Wolfe directs the Health Research Group at Public Citizen, an influential US consumer rights group. Crestor, also known as rosuvastatin, joins more than 200 drugs on the group's "Do Not Use!" list.

Crestor's makers, the Anglo-Swedish drugs giant AstraZeneca, came under fire for over-hyping the new medicine when it was launched. It was claimed the drug was allowed to hit the market on the back of incomplete research findings.

The Lancet said the drug had an "inferior evidence base" compared with its competitors and doctors should think twice before prescribing it.

The journal said Crestor was being promoted "too hard and too fast" to secure AstraZeneca a 20% share of the lucrative statin market.

Dr Wolfe obtained post-marketing reports of adverse reactions to Crestor from the US Food and Drugs Administration (FDA). He identified eight cases of rhabdomyolysis in clinical trials, and a further 18 after the drug was launched up to April 13.

AstraZeneca accused Public Citizen of making "misleading claims" based on inappropriate interpretation of data.

It pointed out that Crestor 10 40mg was now approved in more than 60 countries worldwide and helped more patients achieve their cholesterol goals than any other statin.