Cholesterol Drug Crestor causes concern
01/01/2000
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A spokesman for an influential American consumer rights group has called for a new cholesterol-lowering drug to be taken off the market because of its poor safety record.
Writing in The Lancet medical journal, Dr Sidney Wolfe said the statin drug Crestor was "ultimately doomed". The drug, which was launched in the UK, last year 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.
Dr Wolfe directs the Health Research Group at American consumer group Public Citizen.
Crestor, also known as rosuvastatin, joins more than 200 drugs that have been placed on the group's "Do Not Use!" list over the past 15 years.
They include another statin, Baycol, which was removed from the market in 2001 after at least 31 reports of fatal rhabdomyolysis.
An editorial in The Lancet said the drug had an "inferior evidence base" compared with its competitors and doctors should think twice before prescribing it.
Dr Wolfe used America's freedom of information laws to obtain post-marketing reports of adverse reactions to Crestor from the US Food and Drugs Administration.
He identified eight cases of rhabdomyolysis in clinical trials, and a further 18 after the drug was launched up to April 13.
There had been eight reported cases of acute renal failure and four of renal insufficiency in patients using Crestor since marketing began.
Most of these cases involved people taking low or medium doses of the drug.
An FDA report of rhabdomyolysis linked to other statins showed that the rate ranged from 0.3 per million prescriptions to 1.2 per million.
Dr Wolfe, who has campaigned to persuade the FDA to withdraw Crestor, wrote: "The renal toxicity, high rate of cases of rhabdomyolysis compared with other statins and lack of unique benefit are compelling reasons to remove rosuvastatin from the market before additional patients are injured or killed.
"To allow AstraZeneca to continue desperately seeking a piece of the estimated 20 billion dollars-a-year statin market hardly justifies governments allowing this ultimately doomed drug to stay on the market."
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.
The drug was also well tolerated and had a safety profile similar to other statins when used according to prescription guidelines.
Drug company Astrazeneca said post-marketing experience with Crestor involved almost two million patients and more than five million prescriptions worldwide.
It said reports of rhabdomyolysis were very rare and were often associated with inappropriate use, either in patients with predisposing factors or initiated with higher than recommended start doses."
The European regulatory authorities had recently conducted an extensive review of current safety data for Crestor, he said.
Both they and the FDA agreed that Crestor had a favourable benefit-risk profile.
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