FDANews
FDAnews Drug Daily Bulletin

FDA Evaluating Risks of Opioid Drug for Children

Sept. 29, 2015

The FDA is evaluating the potential risks of prescribing tramadol for children 17 years and younger because it may cause slowed or difficult breathing. The opioid drug is not approved for use in children, but is being prescribed “off-label.”

Health care professionals should be aware of this risk and consider prescribing other FDA-approved pain medicines for children, especially medications that do not have breathing side effects, the FDA says. The risk is increased in children treated with the drug for pain after surgery to remove their tonsils and/or adenoids.

Tramadol is used in 51 approved brand and generic products, including drugs such as Janssen’s Ultram and Cipher Pharma’s Conzip. It is combined with acetaminophen and sold as Ultracet or as generic versions.

The FDA’s warning notice can be read here www.fdanews.com/09-22-15-tramadol.pdf. — Kellen Owings