Posted from: Tuesday, August 04, 2015 - 12:07 PM - Present

Food and Drug Administration to Reassess Safety of Codeine Containing Medications in Children

July 1, 2015 – The U.S. Food and Drug Administration officially announced its investigation of codeine safety in cough and cold medications for all children less than 18 years. This investigation is being conducted because the FDA is concerned about codeine-related incidences of life-threatening breathing complications. Previously, the FDA strongly advised against use of medications containing codeine for pain in post-operative children and will now consider the European Medicines Agency’s stance against use of codeine in any children under the age of 12 when considering its final recommendation.

 

Adverse reactions or quality problems experienced with the use of a recalled product may be reported to the FDA’s MedWatch Adverse Event Reporting Program either online, by regular mail or by fax.

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Last Updated Saturday, August 19, 2017 - 02:42 PM.