Diabetes link to popular statin
There is growing evidence that a popular statin carries a particularly high risk of harmful side-effects, a doctor and campaigner has warned.
The cholesterol-lowering power of rosuvastatin (Crestor) exceeds all other statins but is also associated with the highest increased risk of diabetes, Dr Sidney Wolfe said.
Writing in the BMJ, the founder and senior adviser to US civil rights group Public Citizen's Health Research Group, 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, is also a commonly-used statin in the UK.
Dr Wolfe said o ther 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 US dollars (£5.5bn), the third highest for any branded drug," Dr Wolfe writes.
"Given the longstanding, 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% risk of d eveloping 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% 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."
Professor Peter Weissberg, medical director at the British Heart Foundation, said: "This opinion piece raises more questions about pharmaceutical marketing and prescribing practices in the USA, than the safety and use of statins in general.
"Rosuvastatin is much more expensive than other statins and is one of the least commonly prescribed statins in the UK.
"It is generally prescribed for a small number of people at high risk of a heart attack or stroke and who either cannot tolerate the older statins or have not had the desired reduction in cholesterol levels on them.
"Patients who are taking rosuvastatin should not stop taking it. They are on it for a very good reason."