FDA drug safety communication: Update of codeine use in children- new Boxed Warning and Contraindication on use after tonsillectomy and/or adenoidectomy

Source: FDA Area: News The FDA has notified the public about new actions being taken to address a known safety concern with codeine use in certain children after tonsillectomy and/or adenoidectomy   In August, it had issued an alert, following reports of children who developed serious adverse effects or died after taking codeine for pain relief after these procedures for obstructive sleep apnoea syndrome. These children (aged two to five) had evidence of an inherited ability to convert codeine into life-threatening or fatal amounts of morphine in the body. All children had received doses of codeine that were within the typical dose range.   A new boxed warning, the Agency's strongest warning, will be added to the drug label of codeine-containing products about the risk of codeine in post-operative pain management in children following these procedures. A Contraindication will be added to restrict codeine from being used in this setting. The Warnings/Precautions, Pediatric Use, and ...
Source: NeLM - News - Category: Drugs & Pharmacology Source Type: news