FDA Issues New Warnings About Codeine Use In Children
On February 20, 2013 the United States Food and Drug Administration announced an update to its prior warnings about using codeine in children who have undergone surgery for tonsillectomy and/or adenoidectomy.
Specifically, the FDA issued a drug safety communication, advising patients that it would require pharmaceutical manufacturers of codeine-containing products to add a black-box warning to drug labeling detailing the risks associated with the use of these products post-operatively in pediatric patients who have had surgery for tonsillectomy or adenoidectomy. The boxed warning is the strongest type of warning that the FDA can require manufacturers to place in their drug labeling. The new requirement comes after the FDA reviewed safety data, and confirmed an increased number of deaths and serious adverse reactions in pediatric patients who were prescribed these products postoperatively. The boxed warning will be required to state that these codeine-containing products are contraindicated (recommended not to be used) post-operatively for patients who have had their tonsils or adenoids removed. The FDA postulates that these patients may be at risk for adverse reactions due to the fact that many of these children have underlying breathing problems and thus may be more sensitive to the effects of respiratory depression caused when codeine is converted to morphine by the liver in children who are ultra-rapid metabolizers of codeine. However, this contraindication applies to all children undergoing tonsillectomy and/or adenoidectomy because it is not easy to determine which children might be ultra-rapid metabolizers of codeine.
For more information, see the FDA drug safety communication at the link below:
Tags: adenoidectomy, children, codeine, codeine adverse reactions, deaths, pediatrics, tonsillectomy