Press Release: PRAC recommends restricting the use of codeine when used for pain relief in children

Author (Corporate)
Series Title
Series Details EMA/350259/2013 (14.06.13)
Publication Date 14/06/2013
Content Type

The European Medicines Agency’s Pharmacovigilance Risk Assessment Committee (PRAC), in June 2013, recommended a series of measures to address safety concerns with codeine-containing medicines when used for the management of pain in children. This followed the PRAC’s review of reports of children who developed serious adverse effects or died after taking codeine for pain relief. Most of the cases occurred after surgical removal of the tonsils or adenoids for obstructive sleep apnoea (frequent interruption of breathing during sleep).

Codeine is an opioid that is authorised as painkiller in adults and children. It is converted into morphine in the patient’s body.

Source Link Link to Main Source http://www.emea.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2013/06/news_detail_001813.jsp&mid=WC0b01ac058004d5c1
Related Links
EMA: Press Release: EMA/350259/2013 (14.06.13) http://www.emea.europa.eu/docs/en_GB/document_library/Press_release/2013/06/WC500144444.pdf
EMA: Press Release: EMA/385716/2013 (28.06.13): Restrictions on use of codeine for pain relief in children – CMDh endorses PRAC recommendation http://www.emea.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2013/06/news_detail_001829.jsp&mid=WC0b01ac058004d5c1

Subject Categories ,
Countries / Regions