June meeting highlights from EMA Pharmacovigilance Risk Assessment Committee
The European Medicines Agency’s Pharmacovigilance Risk Assessment Committee (PRAC) has made several recommendations on safety referrals at its June 2013 meeting, including a series of measures to address safety concerns with codeine-containing medicines when used for the management of pain in children.
The PRAC recommended the following risk minimisation measures to ensure that only children for whom benefits are greater than the risks are given the medicine for pain relief:
• Codeine-containing medicines should only be used to treat acute (short lived) moderate pain in children above 12 years of age, and only if it cannot be relieved by other painkillers such as paracetamol or ibuprofen, because of the risk of respiratory depression associated with codeine use.
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