The Food and Drug Administration (FDA) is taking steps to warn about the use of codeine to relieve children's pain after surgery to remove their tonsils or adenoids.
In August 2012, FDA warned the public that this danger exists for children who are "ultra-rapid metabolizers" of codeine, meaning that their liver converts codeine to morphine in higher than normal amounts.
Since then, FDA has conducted a comprehensive safety review of codeine use in children. A search of FDA's Adverse Event Reporting System (AERS) database from 1969 to May 1, 2012 identified 10 deaths and three overdoses associated with codeine. Many of these children were recovering from a surgery to remove their tonsils or adenoids.
The new changes to the codeine label warn health professionals about the use of codeine after tonsillectomy and/or adenoidectormy. FDA says that codeine should only be prescribed to children with other types of pain if the benefits are expected to outweigh the risks.
The agency warns that when prescribed to treat pain, codeine should not be given on a schedule, but only when the child needs relief from pain. Children should never receive more than six doses in a day.
"The most important thing is that caregivers should tell the 911 operator or emergency department staff that their child has been taking codeine and is having breathing problems," Rappaport says.
Talk to your child's health care professional if you have any questions or concerns about codeine. If health care professionals decide that the benefit of prescribing products that contain codeine to pediatric patients outweighs the risk, FDA is advising that the lowest effective dose be prescribed for the shortest period of time.
If your child experiences any side effects from codeine, report them to the FDA MedWatch program.