Don't Give Kids Medicines With Codeine, Tramadol: FDA

Lydia Fleming
April 22, 2017

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 unsafe breathing problems. The FDA also says breastfeeding women shouldn't take them because of possible harm to the baby.

Codeine already carries a black-box warning, which the FDA added in 2013, stating that the medication should not be used to treat a child's pain after surgery to remove his or her tonsils.

Products containing codeine or tramadol will now carry a "Contraindication" for children under the age of 12, which is the FDA's strongest warning.

The agency on Thursday ordered several alternations in labels to underscore the risks of the drugs to children.

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Tramadol is a prescription drug that is only approved for adults to treat pain, the agency noted.

The agency also warned against using the drugs in young people between 12 and 18 who are obese or have breathing problems such as sleep apnea or lung disease.

Labels for both codeine and tramadol are being updated to include additional "Contraindications and Warnings". A similar search for tramadol identified nine cases worldwide of respiratory depression in children 18 years of age, including three deaths; respiratory depression typically occurred within the first 24 hours of drug administration.

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. If a codeine-or tramadol-containing product is determined to be appropriate for an adolescent patient, clinicians should provide counseling on how to recognize the signs of opioid toxicity.

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"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. These can include excess sleepiness, difficulty breastfeeding, or serious breathing problems that could result in death. After several deaths were reported, the American Academy of Pediatrics warned parents against giving codeine to children past year.

Meanwhile, the FDA advises Clinicians to refer parents to seek over-the-counter products or possibly FDA-approved prescription medicines that are not fatal to kids under 12-years old.

There are also alternative OTC and prescription medications available for cough.

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Unlike adults, some children don't metabolize the drug, which prompts adults to give a higher dose in order for the medication to be effective.

Other reports by Info About Network

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