FDA Examines Pediatric Codeine Risks
The FDA is investigating the potential risks of medicines containing codeine to treat coughs and colds in children 18 and younger because of the potential for serious side effects, according to a safety announcement released last week.
The agency says it will evaluate all available information and will establish an advisory committee of medical experts to discuss safety issues. While no date has been set, the FDA will also convene a public meeting to discuss concerns and determine if additional action is needed.
The FDA’s move follows an announcement in April by the European Medicines Agency’s Co-ordination Group for Mutual Recognition and Decentralized Procedures – Human limiting use of codeine in children.
To minimize risks associated with codeine, the CMDh recommended that it not be used by children younger than 12 and children 12 to 18 who have breathing problems. The panel studied 14 cases of codeine intoxification in children age six and younger that resulted in four deaths.
In 2013, the FDA warned against codeine use in children who recently had surgery to remove their tonsils and/or adenoids.