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Life-saving statins should stay, rules MHRA

MHRA reassure patients after BMJ withdraws statement that suggested side effects occurred in up to 20 per cent of patients who used statins

Statins save lives and should continue to be prescribed, the MHRA has confirmed.


The "widely used" medicines should continue to be dispensed because they reduced heart attacks, strokes and the need for bypass surgery, the medicines watchdog said last week (May 30).


The MHRA's announcement came two weeks after the BMJ withdrew statements from two articles that suggested adverse side effects occurred in up to 20 per cent of patients treated with statins. This was due to the authors "misreading" the number of patients who had discontinued treatment due to side effects, the journal said.


The MHRA said in a statement that evidence from large clinical trials had shown that the lipid regulators' benefits outweighed the risks and could save lives in certain patient groups.


MHRA director of vigilance and risk management of medicines June Raine said the medicines watchdog "continually reviewed" information on the safety of statins and would update its prescribing advice "in light of any substantial new evidence" of safety concerns. Dr Raine advised patients with any concerns about their medicines to speak to their doctor.


Statins reduce heart attacks, strokes and the need for bypass surgery, the MHRA said

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In a group of 10,000 patients with at least a 20 per cent risk of suffering a cardiovascular event within 10 years, statins could prevent 450 heart attacks, strokes or vascular deaths, the MHRA said.


Although statins produced side effects in some patients who took part in the trials, most were mild and "not medically serious" muscle-related problems, it said.


For every 100,000 patients treated with statins, it was estimated that 190 would experience mild muscle pain, five would suffer myopathy and 1.6 would experience rhabdomyolysis, the MHRA said.


This risk of myopathy was found to be dose-dependent and increased when the statin was taken with other treatments, according to studies from electronic medical record databases, it added.


In March, a study published in the Lancet found that a daily dose of simvastatin 80mg slowed brain shrinkage by 43 per cent over two years in patients with secondary progressive multiple sclerosis.


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2 Comments

Faiz Yusuf, Locum pharmacist

As widesread prescribing of statins is only 10 years or so,we don't know the long term side effects of this medication. I know patients who take every other day or have unused statins under the sink.Obviously ,the cardio- & cerebrovascular benefits are well documented but the long term side effects are not known & only time will tell.

Gerry Diamond, Primary care pharmacist

In other words as the Doc says....keep taking the pills!

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