Don't give kids medicines with codeine, tramadol: FDA

USA regulators are strengthening warnings about the dangers of two types of powerful opioid painkillers, codeine and tramadol, due to risks of slowed breathing and death.

"We require these changes because we know that some children who received codeine or tramadol have experienced life-threatening respiratory depression and death because they metabolize (or break down) these medicines much faster than usual (called ultra-rapid metabolism)", said Douglas Throckmorton, deputy director at Center for Drug Evaluation and Research.

The FDA also warned nursing mothers who are taking the medications can pass unsafe levels of opioids to their babies through breast milk. In 2013, the agency restricted use of codeine in children to treat pain after surgery to have tonsils and adenoids removed.

The FDA will continue to monitor this safety issue and is considering an FDA Advisory Committee meeting to discuss the role of prescription opioid cough-and-cold medicines in children.

Children's bodies tend to process opioids more quickly than most adults, due to their smaller size.

In 2015, the FDA acknowledged that although tramadol is not approved for use in children, it is used off-label to treat pain in kids.




The analysis found that the drugs carry serious risks for patients under the age of 12, including difficulty breathing and death, and that they carry a risk for adolescents up to age 18 who have breathing troubles.

In its statement, the FDA has rounded up a list of codeine-containing drugs to watch out for - such as codeine sulfate, codeine phosphate, Butalbital, Acetaminopen, Tylenol, Promethazine, Prometh VC, Triacin-C, Tuxarin ER, and Tuzistra-XR.

Narcotics such as codeine and tramadol are not only fatal to kids under 12 years of age, but also have negative effects on nursing mothers, a report by CBS News suggests. They also can ask their doctor or pharmacist if a specific medication contains codeine or tramadol.

"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", explained Throckmorton.

The FDA officials also urged parents to check the ingredients of over-the-counter medications and to be extremely careful of giving children any that contain codeine. Between January 1969 and March 2016, there were nine cases of breathing problems including three deaths, involving the use of tramadol in children younger than 18. According to the FDA's public label database, more than 100 medications containing codeine are approved for sale without a prescription in the U.S.

For more on opioid medications in pediatrics, visit the Boston Children's Hospital.

(Copyright © 2015. All Rights Reserved.)
 
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