Tag Archives: Contraindications

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MHRA Drug Safety Update Summary

In August 2012 we published advice that simvastatin is now contraindicated with concomitant use of certain medicines, such as ciclosporin, danazol, and gemfibrozil. In addition, the recommendations for the maximum dose of simvastatin have changed when used with a number of other medicines, including amlodipine and diltiazem. These changes were driven primarily by concerns about an increased risk of myopathy and/or rhabdomyolysis at higher plasma concentrations of simvastatin, which may result from such drug interactions.

Following further consideration by the Pharmacovigilance Expert Advisory Group of the Commission on Human Medicines, this article summarises the evidence underlying the new advice that the maximum recommended dose for simvastatin in conjunction with amlodipine and diltiazem is now 20 mg/day. The prescribed doses of amlodipine and diltiazem need not be changed.

MHRA Drug Safety Update – Statin