Simvastatin contraindications expanded by drug watchdog

Simvastatin product warnings will be expanded to include additional contraindications, the MHRA has said.

Cholesterol-lowering drug simvastatin (Photo: SPL)
Cholesterol-lowering drug simvastatin (Photo: SPL)

The summary of product characteristics for simvastatin products will now include contraindications against concomitant use of simvastatin alongside ciclosporine, danazol and gemfibrozil.

In May 2010, the MHRA warned about the increased risk of myopathy associated with use of high-dose simvastatin (80 mg daily). The agency said that further changes now need to be made to the warnings on use of simvastatin in light of ‘recent analysis of clinical trial data, spontaneously reported cases and drug-drug interaction studies’.

Changes are also being made to the maximum dose recommendations when simvastatin is taken with a number of other medicines, the MHRA said. These interactions may increase plasma concentrations of simvastatin which is associated with an increased risk of myopathy and/or rhabdomyolysis. The maximum recommended dose for simvastatin in conjunction with amlodipine or diltiazem is now 20 mg/day.

A full updated listing of all the interactions is available on the MHRA website.

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