The FDA literature review spans multiple decades (1969–2015) and identified 64 cases of serious breathing problems, including 24 deaths, with the use of codeine-containing products in patients younger than 18 years old. Additional cases may exist that were not reported to the FDA. With tramadol, FDA identified nine cases of serious breathing problems, which included three deaths, in patients younger than 18 years old. Most of the serious side effects with both medications occurred in children younger than 12 years old, some of which occurred after a single dose.
Numerous infants of breastfeeding mothers experienced excessive sleepiness and serious breathing problems, and one death was reported. Tramadol use during breastfeeding did not result in any adverse events, but risk does exist because tramadol and its active ingredient are excreted into breast milk.
Michele B. Kaufman, PharmD, BCGP, is a freelance medical writer based in New York City and a pharmacist at New York Presbyterian Lower Manhattan Hospital.
References
- Silvergate Pharmaceuticals Inc. News release: FDA approves Xatmep, the first and only ready-to-use methotrexate oral solution. 2017 Apr 26.
- U.S. Food and Drug Administration. FDA drug safety communication: FDA restricts use of prescription codeine pain and cough medicines and tramadol pain medicines in children; recommends against use in breastfeeding women. 2017 Apr 20.
