Frequently Asked Questions for Pharmacists on Codeine-containing Products and Tramadol Products
Q. What does the FDA advise on codeine-containing products and tramadol products in the treatment of children?
A. FDA REQUIRES STRENGTHENED WARNINGS ON LABELING FOR CODEINE-CONTAINING PRODUCTS AND TRAMADOL PRODUCTS
In fall 2017, the U.S. Food and Drug Administration required manufacturers of codeine-containing and tramadol containing products to strengthen warnings on those products’ labeling. Specifically, FDA has advised that children younger than 12 should not take codeine-containing products to treat pain or cough, and children younger than 12 should not take tramadol products to treat pain. FDA also warns that children younger than 18 should not take tramadol products to treat pain after surgery to remove the tonsils (tonsillectomy) or adenoids (adenoidectomy). Finally, FDA warns that youths ages 12 through 18 who are obese, have obstructive sleep apnea (blocked airflow during sleep), or have a weakened respiratory system should not take codeine-containing products or tramadol products.
More information is located here: https://www.fda.gov/forconsumers/consumerupdates/ucm315497.htm