FDA has new safety warning, label requirements for codeine, tramadol
The FDA has issued a safety warning regarding the use of codeine and tramadol in children, a release posted on the American Academy of Family Physicians website said.
The drugs are used to treat pain and cough and the FDA stated they should not be used in children under 12 years of age. The FDA also recommended that breastfeeding mothers not use the medications to protect their infants from any possible harm.
"We are requiring these changes because we know that some children who received codeine or tramadol have experienced life-threatening respiratory depression and death because they metabolize these medicines much faster than usual (called ultra-rapid metabolism), causing dangerously high levels of active drug in their bodies," Deputy Center Director for Regulatory Programs in the agency’s Center for Drug Evaluation and Research Douglas Throckmorton said in the release.
The FDA previously required codeine labels to have a boxed warning and contraindication for those up to 18 years old. The labels will now be updated and include additional contraindications and warnings regarding the use in children under 12, children between 12 and 18 years that have certain medical conditions and breastfeeding mothers.
Labels on products containing tramadol will be required to have a contraindication for children up to 18 years that have had a tonsillectomy or adenoidectomy.
“We understand that there are limited options when it comes to treating pain or cough in children, and that these changes may raise some questions for health care providers and parents. However, please know that our decision today was made based on the latest evidence and with this goal in mind: keeping our kids safe,” Throckmorton said in the release.
Organizations in this story
American Academy of Family Physicians 11400 Tomahawk Creek Pkwy Leawood, KS 66211
U.S. Food and Drug Administration (FDA) 10903 New Hampshire Ave Silver Spring, MD 20903