Is Tramadol Safe for Children?

That’s a question that the U.S. Food and Drug Administration (FDA) is looking at right now because the drug presents the risk, though rare, of causing difficult or slow breathing.

Recently, a five-year-old child in France took one dose of the prescribed medication post- tonsillectomy and experienced difficult and severely slowed breathing that resulted in hospitalization.

Although tramadol is not approved for use in children in the United States, the agency reported that their data revealed its “off-label” among children 17 and younger.

“Health care professionals should be aware of this and consider prescribing alternative FDA-approved pain medicines for children,” the FDA said in a safety communication.

The FDA is in the process of investigating all data on use of tramadol among children and will issue its findings and recommendations when finished.

Tramadol is available as a generic and has the brand names Conzip, Ultram, and Ultram ER, as well as in combination with acetaminophen as Ultracet and in generic form.

Click here to read the full announcement.

--Stephanie Vaccaro

Reference:

1. U.S. Food and Drug Administration. FDA Drug Safety Communication: FDA evaluating the risks of using the pain medicine tramadol in children aged 17 and younger. www.fda.gov. 2015 Sep 21.