U.S government says statin bottles must carry warning over diabetes risk – so why are British users being left in the dark
Statin benefit it indisputable but need to be taken with 'knowledge of side effects', says FDA
Around seven million adults in the UK take statins
Taking statins can raise blood sugar levels and increase the risk of developing Type 2 diabetes, the U.S. Food and Drug Administration has revealed.
The FDA said they will add a warning to statin labels that they may raise levels of blood sugar.
FDA spokeswoman Amy Egan, said: 'Their benefit is indisputable, but they need to be
taken with care and knowledge of their side effects.'
Seven million people in the UK now take the drugs to lower their cholesterol – the fatty substance in the blood that clogs up arteries.
They are proven to prevent heart attacks and strokes and are taken by as many as one in three adults over the age of 40.
The pills cost around 40p a day and make up nearly a fifth of all medicines prescribed for heart and circulatory disease.
However, the health regulator in the UK has no immediate plans to include the warning on bottle labels.
So while popular brands including Pfizer Inc's
Lipitor and AstraZeneca's Crestor will need
to include a new warning on their labels in the U.S., they will not have to on the same products in the UK.
This is despite the Medicines and healthcare Products Regulatory Agency (MHRA) publishing a safety alert on its website in January, saying there is 'sufficient evidence' to support a link between statin use and diabetes.
The MHRA points out that the risk appears to be mainly in patients already at increased risk of developing diabetes.
It added in a statement that the 'benefits of statins strongly outweigh any risks.'
However, it's not the first time that statin labeling has hit controversy. In February 2008, the MHRA found that memory loss was another rare side effect of taking statins.
The regulator said product information would be updated to reflect this, however labels were not updated until November 2009.
High doses of cholesterol-lowering pills can increase the risk of type 2 diabetes, researchers warn
According to a commentary piece in the Drugs and Therapeutics Bulletin, published in the British Medical Journal, the delay was caused by a drug company who stalled the process by quibbling over the precise 'wording' on the labels.
'A drug company has been
able to stall the
inclusion of key safety warnings. In our
view, this situation is unacceptable and should be rectified quickly,' it said.
In the U.S, the FDA said that statins labels will also hold a warning about the increased risk of confusion and memory loss.
It also announced it is removing the requirement that doctors should monitor a patient's liver enzymes for organ damage, saying 'such serious damage is rare, and regular testing for all users isn't necessary.'
However, regular liver enzyme tests are still advised by the NHS and are set to continue.
The Cochrane Library recently said there
was little evidence of protection unless a person’s risk of a heart
attack was already high.
about side effects such as fatigue, muscle pain, sexual dysfunction and
weakness, continue to emerge, with estimates ranging from one to 20 per
cent of patients affected.
However, a daily dose of statins has also been linked with preventing cancer.
It could slash the risk of breast cancer recurring, according to a study from Harvard Medical School published in December 2011.
They found that women who had
developed a breast tumour were nearly 30 per cent less likely to suffer a
relapse if they took a type of statin called simvastatin.
Meanwhile a team at the Cleveland Clinic, in
Ohio, found it cut the risk of prostate cancer.
They looked at tissue samples from more than 4,000 men who underwent
biopsies because doctors suspected they had prostate cancer.
taking statins for high cholesterol were nearly 10 per cent less likely
to be diagnosed with a tumour and 24 per cent less likely to have an
aggressive cancer than men who were not.