FDA Issues New Label Change for Codeine and Tramadol
Decades of research has led to a flurry of new warnings.
The FDA is now warning against the use of codeine and tramadol in children under the age of 12. The warning is due to a higher incidence of slowed or difficult breathing and death in children.
The new labeling for products containing codeine adds a warning that they should not be used to treat cough in children under 12. Labeling for tramadol states that it should not be used to treat pain in children under 12 or used in children under 18 to treat pain after a tonsillectomy and/or adenoidectomy.
The FDA is also adding a warning recommending against the use of these drugs in children between 12 and 18 who have conditions such as obstructive sleep apnea or severe lung disease, because of the increased risk of severe breathing problem. Finally, the labels also include a strengthened warning to mothers that breastfeeding is not recommended when taking either codeine or tramadol, as this can cause serious adverse reactions in their babies or toddlers.
Related article: Children prescribed codeine in ERs despite risks
The new warnings and contraindications come after the 2013 restriction of codeine use in children under 18 to treat pain after a tonsillectomy and/or adenoidectomy. In July and September of 2015, the FDA issued a Drug Safety Communications warning about the risk of serious breathing problems in children with ultra-rapid metabolism of codeine and tramadol, as this could lead to a quick rise to unsafe levels of the drugs.
The FDA reviewed data from January 1969 to May 2015, and identified 64 cases of serious breathing problems (including 24 deaths) with codeine-containing medicines in children younger than 18 years. The FDA also found nine cases of difficulty breathing (including three deaths) with use of tramadol in children under 18 between January 1969 and March 2016. The majority of the serious side effects occurred in children under 12.
The FDA has said that it will continue to monitor the issue, and is considering regulatory action for OTC codeine products that are available in some states.
Optimize Your Healthcare Payments with Optum Financial
April 29th 2025Discover how Optum Financial is revolutionizing healthcare payments in our latest whitepaper. Learn how transitioning to electronic payments can reduce administrative costs, streamline claims processing and enhance security.
Read More
Conversations With Perry and Friends
April 14th 2025Perry Cohen, Pharm.D., a longtime member of the Managed Healthcare Executive editorial advisory board, is host of the Conversations with Perry and Friends podcast. His guest this episode is John Baackes, the former CEO of L.A. Care Health Plan.
Listen
Healthcare hasn't been a priority of the second Trump administration so far, panelists at the Asembia agreed. Medicaid may loom large, though, as the administration and congressional Republicans look for ways to slash government spending as a way of offsetting major tax cuts.
Read More
Breaking Down Health Plans, HSAs, AI With Paul Fronstin of EBRI
November 19th 2024Featured in this latest episode of Tuning In to the C-Suite podcast is Paul Fronstin, director of health benefits research at EBRI, who shed light on the evolving landscape of health benefits with editors of Managed Healthcare Executive.
Listen
What 5 Managed Care Trends Experts Say You’re Not Watching Closely Enough
April 29th 2025Managed Healthcare Executive asked several experts in healthcare and managed care two share the trends they think the industry is overlooking. From rising costs and data challenges to shifts in how care is delivered, these are the issues that could have a major impact — and deserve a closer look.
Read More
