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MHRA announces new contraindications for simvastatin

Clinical Simvastatin is now contraindicated with ciclosporin, danazol and gemfibrozil following evidence of an increased risk of myopathy or rhabdomyolysis (the breakdown of muscle fibres).

Simvastatin is now contraindicated with ciclosporin, danazol and gemfibrozil, and should not be used at doses higher than 20mg a day in patients taking diltiazem or amlodipine, the MHRA has said.

Simvastatin is now contraindicated with ciclosporin, danazol and gemfibrozil

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The changes follow new evidence of the possibility of raised simvastatin plasma concentrations when taken concomitantly, thus increasing the risk of myopathy or rhabdomyolysis (the breakdown of muscle fibres).

The MHRA has previously warned simvastatin 80mg is associated with an increased risk of myopathy and should only be used in patients with severe hypercholesterolaemia or at high risk of cardiovascular complications, if lower doses do not prove effective.

Simvastatin is also contraindicated in patients taking erythromycin, clarithromycin, ketoconazole and itraconazole, and patients should be advised to avoid drinking grapefruit juice. Simvastatin doses should not exceed 20mg a day in patients also taking amiodarone and verapamil.


Are these contraindications relevant to many of your patients?

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2 Comments

Leanne Macdonald, Locum pharmacist

If patients have been on the combination of simv 40mg and amlodipine for a number of years with no problems, then I can't understand why GPs are being advised to reduce the simv dose or switch to a different statin; since surely it is unlikely they are going to experience problems now?? Am I missing something??

Gerry Diamond, Primary care pharmacist

Very useful info for all pharmacists esp wrt to MURs.

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