FDA Announces Restrictions on Prescriptions Containing Codeine, Tramadol

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.

The FDA has issued a drug safety communication regarding new restrictions for the use of codeine and tramadol medications in children and nursing mothers. Drugs containing codeine already carry a black-box warning against using it to treat pain in children who have their tonsils removed.

The new warnings do not further restrict over-the-counter medicines that contain codeine, such as popular types of cough syrup and medication marketed for cold and flu symptoms.

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

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

The FDA is reminding healthcare professionals that tramadol and single-ingredient codeine medications are only FDA-approved for adult use.

"These medicines carry serious risks, including slowed or hard breathing and death, which appear to be a greater risk in children younger than 12 years, and should not be used in these children", the agency wrote in its safety announcement.

There are some people who are "ultrarapid metabolizers" or whose livers process the drugs way too quickly, which is not good because it can lead to dangerously high levels of opioids to build up in the body, Dr. Douglas Throckmorton, the deputy center director for regulatory programs at the FDA's Center for Drug Evaluation and Research, explained. Codeine is often combined with acetaminophen in prescription pain medicines and with other cold medicines for treatment of cough. Besides a change saying that the drugs shouldn't be used in children under 12, the mandated changes include a new warning for tramadol saying it shouldn't be used in children younger than 18 for post-surgical pain after the removal of tonsils and adenoids. However, please know that our decision today was made based on the latest evidence and with this goal in mind: "keeping our kids safe". 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. The same will now be true for tramadol-containing products. However, with the limited options available when it comes to treating pain and cough in children, it may be harder to find the appropriate medical approach. Finally, FDA is adding a strengthened Warning to mothers that breastfeeding is not recommended when taking codeine or tramadol medicines due to the risk of serious adverse reactions in breastfed infants.

  • Ismael Montgomery