There is growing evidence that a popular statin carries a particularly high risk of harmful side-effects, a leading doctor claims today.
The cholesterol-lowering power of rosuvastatin (Crestor) exceeds all other statins but is also associated with the highest increased risk of diabetes.
Writing in the BMJ, the founder and senior adviser to US civil rights group Public Citizen’s Health Research Group, Sidney Wolfe, claimed evidence of its health benefits had always been weak.
He said there was now growing evidence the drug carried a higher risk of harmful side effects.
He said its approval to prevent heart attacks in a very select group of people was based on the results of a study which was stopped early, leading to concern that the treatment effects may have been overestimated.
The drug, which was the most prescribed brand name drug in the US last year with more than 22 million prescriptions, is also a commonly-used statin in the UK.
Dr Wolfe said other serious side effects include rhabdomyolysis - a rare condition that causes muscle cells to break down - and renal problems.
Public Citizen asked the US Food and Drug Administration (FDA) to ban the drug in 2004 because of its concerns.
“Worldwide 2013 sales were $8.2 billion (£5.5bn), the third highest for any branded drug,” Dr Wolfe writes.
“Given the long-standing, continuing evidence of rosuvastatin’s comparative lack of clinical benefits and increasing evidence of risks, how did this happen?
“The short answer is that of statins still on the market, the milligram for milligram cholesterol lowering potency of rosuvastatin exceeds all others, a fact exploited in advertising campaigns.”
Statins are the most commonly prescribed group of drugs in the NHS with up to 10 million people in England estimated to be taking them.
They are currently offered to people in the UK who have a 20 per cent risk of developing cardiovascular disease within 10 years.
But updated guidance from the National Institute for Health and Care Excellence (Nice) last year called for the NHS to widen this to cover people with just a 10 per cent risk.
A spokesman for the Medicines and Healthcare Products Regulatory Agency (MHRA) said: “Statins are safe and effective medicines and play an important role in reducing the risk of heart attack and stroke.
“Information on possible risks with statins are already contained in the information to prescribers and patients and people should continue to take their medicines as prescribed.
“If anybody has any questions they should speak to their GP or pharmacist. The MHRA continually reviews the information on the safety of statins and updates the the prescribing advice and information for patients where necessary.”
Pharmaceutical giant AstraZeneca, which markets in the drug, said it was an effective treatment.
It added: “AstraZeneca takes it commitment to patient safety extremely seriously and Crestor has a well-established safety profile backed by peer-reviewed clinical research spanning 13 years and 120 ongoing or completed clinical trials. It is approved by healthcare authorities in over 109 countries and used by tens of millions of patients worldwide.”