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

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

The Food and Drug Administration on Thursday sharply ratcheted up its warnings about giving children prescription medicines with codeine and tramadol, saying the drugs could cause severe breathing problems and death.

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. Respiratory depression can also occur in nursing babies, when mothers who are ultra-rapid metabolizers take these types of medicines and pass it along to their children through their breast milk.

Throckmorton said that the agency was both increasing restrictions on the products' labels and issuing a warning to consumers and pediatricians because of new information and concerns about the drugs' risks.

Thursday's announcement was a partial acceptance of 2015 recommendations by an independent advisory committee that recommended the agency restrict prescription of codeine-containing drugs for children and also voted overwhelmingly against over-the-counter sale of codeine-containing cough syrup for children.

The FDA is now warning against children under 12 taking either codeine or tramadol.

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.

Codeine is a narcotic painkiller and cough suppressant with similar effects to morphine and hydrocodone, which are strong opioid medication.

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". These can include excess sleepiness, difficulty breastfeeding, or serious breathing problems that could result in death.

The agency listed 15 medicines affected by the action, plus all of their generics, which included J&J's Tylenol with codeine and Vertical's tramadol med ConZip. The same will now be true for tramadol-containing products.

A contraindication to the codeine and tramadol labels alerting users that codeine should not be used to treat pain or cough and tramadol should not be used to treat pain in children younger than 12 year sold. The FDA urged parents to carefully read labels of nonprescription cough medicines to avoid codeine and to consult a doctor or pharmacist if needed.

"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 health care providers and parents".

Conclusively, parents should actively check for any warning labels on medication that they plan to give to their children.

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