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UK MHRA Drug Safety Update: July 2013 (Volume 6, Issue 12)

The monthly newsletter (Volume 6, Issue 12 (July 2013) from the Medicines and Healthcare products Regulatory Agency and its independent advisor the Commission on Human Medicines

 

Drug safety advice

 

Codeine for analgesia: restricted use in children because of reports of morphine toxicity
Codeine should only be used to relieve acute moderate pain in children older than 12 years and only if it cannot be relieved by other painkillers such as paracetamol or ibuprofen alone.
Furthermore, a significant risk of serious and life-threatening adverse reactions has been identified in children with obstructive sleep apnoea who received codeine after tonsillectomy or adenoidectomy (or both).

 

Retigabine (Trobalt▼): indication restricted to last-line use, and new monitoring requirements after reports of pigment changes in ocular tissue, skin, lips, or nails
Retigabine (Trobalt▼) should now only be used as an adjunctive treatment for drug-resistant partial onset seizures with or without secondary generalisation in patients age 18 years or older with epilepsy, where other appropriate drug combinations have proved inadequate or have not been tolerated.  Pigment changes (ie, discolouration) of ocular tissue—including the retina—have been reported in two long-term clinical studies of retigabine and a compassionate use programme.

 

Ondansetron for intravenous use: dose-dependent QT interval prolongation—new posology
There is new guidance for intravenous use of ondansetron in relation to: repeat dosing for all adults; dosing for prevention of chemotherapy-induced nausea and vomiting in patients age 75 years or older; and dilution and administration for patients age 65 years or older

 

Other information from the MHRA

 

The Pharmacovigilance Risk Assessment Committee: strengthening surveillance of medicines throughout the EU
The EU Pharmacovigilance Risk Assessment Committee (PRAC) is a scientific committee at the European Medicines Agency that is responsible for the assessment and monitoring of the safety of medicines. This includes the detection, analysis, risk minimisation and communication of adverse reactions. PRAC is a fairly new committee, established as part of new EU pharmacovigilance laws that came into effect in July 2012 to help strengthen the safety monitoring of medicines across Europe.

 

Posted on the UK MHRA website on 11 July 2013

2016-12-11T18:40:35+00:00 12.07.2013|Pharmacovigilance, Regulatory Affairs|