Drug Safety Update

Volume 6, Issue 1 August 2012

Latest advice for medicines users

Simvastatin: updated advice on drug interactions - updated contraindications

Article date: August 2012

We have previously communicated on the increased risk of myopathy associated with use of high-dose simvastatin (80 mg daily) – see Drug Safety Update May 2010.

Considering the risk of myopathy associated with simvastatin, recent analysis of clinical trial data, spontaneously reported cases and drug- drug interaction studies has resulted in further changes to the simvastatin prescribing information. 

The changes include contraindications to concomitant use with certain medicines and maximum dose recommendations when simvastatin is taken with a number of other medicines, as these interactions may increase plasma concentrations of simvastatin which is associated with an increased risk of myopathy and/or rhabdomyolysis. Key points to note are that:

  • Simvastatin is now contraindicated with ciclosporin, danazol and gemfibrozil
  • 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 provided in the table below.

Drug interactions associated with increased risk of myopathy/rhabdomyolysis

Interacting agents Prescribing recommendations
Itraconazole
Ketoconazole
Posaconazole
Erythromycin
Clarithromycin
Telithromycin
HIV protease inhibitors (eg, nelfinavir)
Nefazodone
Ciclosporin
Danazol
Gemfibrozil
Contraindicated with simvastatin
Other fibrates (except fenofibrate) Do not exceed 10 mg simvastatin daily
Amiodarone
Amlodipine
Verapamil
Diltiazem
Do not exceed 20 mg simvastatin daily
Fusidic acid Patients should be closely monitored. Temporary suspension of simvastatin treatment may be considered.
Grapefruit juice Avoid grapefruit juice when taking simvastatin

 

Further information:
BNF section 2.12: Lipid-regulating drugs 
 

Article citation: Drug Safety Update August 2012, vol 6, issue 1: S1

References

Search tips and FAQs
  • Looking for previous DSU publications?

    Search by publication date above or view earlier publications in PDF
Page last modified: 29 January 2013