Statin benefits still outweigh risks, says MHRA

The benefits of statins to lower cholesterol continue to outweigh risks for most patients, the UK's drug watchdog has said following controversy around potential harms from the drugs.

Statins: GPs advised to continue prescribing (Photo: iStock)
Statins: GPs advised to continue prescribing (Photo: iStock)

The MHRA said current evidence shows the benefits of using statins exceed any potential risks of adverse effects for the majority of patients, although it will continue review the medicines' safety.

Last month, authors of two BMJ papers withdrew claims that cast doubt on proposals to lower the threshold for statin therapy, leading to a public debate about the true benefits and risks of the drugs.

The articles cited data from a uncontrolled, observational study and authors incorrectly concluded that statin side effects occur in 18-20% of patients, the BMJ said.

NICE has proposed lowering the 10-year risk threshold for statin therapy to 10% from 20%, but this has proved controversial among the medical profession.

An MHRA drug safety update published last week said evidence from large clinical trials showed clear benefits through reduced MIs, strokes and deaths. But these had not investigated side effects as the main outcomes, 'so this data is not enough to establish the safety profile of statins'.

However, it noted that most reported side effects, usually muscle-related problems, are generally mild. GPs should advise patients suffering muscle problems to seek medical attention, as rarely this can  lead to fatal rhabdomyolysis.

The MHRA concluded: 'The benefits of using any statin in its licensed indication outweigh the risks in most patients. As with all medicines, the MHRA constantly reviews the safety of statins and will inform prescribers and patients when new, important information becomes available.'

It advised GPs and other prescribers: 'In deciding whether to offer statin therapy, carefully consider both the potential benefits and harms for each patient.'

Dr June Raine, the MHRA’s director of vigilance and risk management of medicines, said: 'People should continue to take their statins as prescribed. Large clinical trials have shown that statins can save lives by reducing the risk of heart attacks, strokes and the need for heart surgery.'

A study published in March found almost all reported side-effects of taking statins were also present in patients taking placebo.

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