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Prescribing Advice for GPs

An NHS Prescribing Advisers' Blog

Drug Safety Update - June 2013

The Medicines and Healthcare products Regulatory Agency (MHRA) has published Drug Safety Update for June 2013 (PDF).

This issue contains drug safety advice informing clinicians of the new contraindications and warnings for diclofenac after a Europe-wide review of cardiovascular safety. This section also advises that a recent review of cyproterone acetate with ethinylestradiol (co-cyprindiol) has found that the balance of benefits and risks remains positive with a reminder that, while rare, healthcare professionals and patients should remain vigilant for signs and symptoms of venous thromboembolism.

The hot topic section reminds clinicians that the risk of foetal malformation with oral retinoids is extremely high, even when used at a low dose or for a short time during pregnancy. Women of child-bearing potential should have pregnancy excluded before starting treatment and while taking these medicines one or preferably two different forms of contraception must be consistently used.

Finally, the stop press section briefly details some new restrictions on the use of codeine as an analgesic in children and adolescents. Codeine should now only be used to relieve acute moderate pain in children older than 12 years and only if other painkillers such as paracetamol or ibuprofen alone cannot relieve it. The maximum daily dose is recommended as 240mg in split daily doses, used at the lowest effective dose for the shortest period and a maximum of 3 days before a review.

Action: Clinicians will find this publication to be a useful review of current issues in drug safety.

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