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MHRA confirms benefits of statins outweigh risks

MHRA confirms benefits of statins outweigh risks

The Medicines and Healthcare products Regulatory Agency has confirmed that, despite well-publicised controversies, the benefits of statins “continue to outweigh the risks of any side-effects”.

It cites, for example, meta-analyses showing that treating 10,000 patients with a 10-year CV risk of at least 20 per cent for five years would prevent at least 450 heart attacks, strokes or vascular deaths.

Mild, muscle-related problems are the most frequently reported side-effects with statins, says the MHRA, which quantifies the risk as:

  • Mild muscle pain: 190 cases per 100,000 patient years
  • Myopathy: five cases per 100,000 patient years
  • Rhabdomyolysis: 1.6 cases per 100,000 patient years.

“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,” commented June Raine, the MHRA’s director of vigilance and risk management of medicines.

“The MHRA continually reviews the information on the safety of statins. We will update the prescribing advice for statins in light of any substantial new evidence of safety concerns.”

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