FDA further restricts pain medication use in kids

Makers of pain medicines containing codeine and tramadol have been ordered by the FDA to make new labels banning under-12s from using their product

Some children who have taken codeine or tramadol have suffered life-threatening breathing problems and in some cases.

It's also important to check non-prescription cough and cold medicines that may be sold over the counter, as some of these medicines also include codeine. In addition, the Agency is recommending against the use of codeine and tramadol medicines in breastfeeding mothers due to possible harm to their infants. FDA has also identified nine cases of severe breathing problems, including three deaths, with the use of tramadol in children younger than 18 years from January 1969 to March 2016, it added.

A 2012 review of pediatric deaths linked to codeine use resulted in an FDA boxed warning restricting its use in children younger than 18 years to treat pain after surgery to remove tonsils and adenoids.

Finally, the FDA said that these drugs should not be used in children 12 to 18 who are obese, suffer from obstructive sleep apnea or have a weakened respiratory system, as they can increase the chances of risky breathing problems.

Now, labels for both codeine and tramadol are being updated to include additional Contraindications and Warnings; among the updates are Contraindications for use of codeine or tramadol in all children younger than 12 years of age, warnings about their use in children 12-18 years of age with certain medical conditions, and a stronger warning recommending against their use in nursing mothers. In that warning, the agency noted that some people are what's known as ultra-rapid metabolizers of tramadol and codeine.

Numerous products containing these drugs are only available by prescription, but several over-the-counter cough medicines contain codeine.

The U.S. Food and Drug Administration (FDA) Thursday advised against the use of two narcotic painkillers - codeine and tramadol - on children under 12 and nursing mothers.

"Today's actions build on a better understanding of this very serious safety issue, based on the latest evidence", Throckmorton said.

"We understand that there are limited options when it comes to treating pain or cough in children, and that these changes may raise some questions for healthcare providers and parents", said Throckmorton.

Dr. Thomas Green, co-author of the American Academy of Pediatrics report advising against codeine use, said these prescriptions, "are just very risky, especially for kids". Those infants can become too sleepy, have difficulty breastfeeding, or have serious breathing problems. After several deaths were reported, the American Academy of Pediatrics warned parents against giving codeine to children past year. Codeine products are available by prescription and, in some states, over-the-counter (OTC).

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