FDA says cough-and-cold medicines with codeine should not be used on children

Parents should pay close attention to what kind of cough-and-cold medicine they use on their children as the FDA recently update their risk evaluation on products with codeine and tramadol.

New FDA warnings have been issued regarding the use of cough-and-cold medicine and pain relievers on children. According to the new risks update, products containing codeine and tramadol should not be used on children as they can potentially have deadly effects.

“The Food and Drug Administration  is restricting the use of codeine and tramadol medicines in children. Codeine is approved to treat pain and cough, and tramadol is approved to treat pain. These medicines carry serious risks, including slowed or difficult breathing and death, which appear to be a greater risk in children younger than 12 years, and should not be used in these children. These medicines should also be limited in some older children. Single-ingredient codeine and all tramadol-containing products are FDA-approved only for use in adults,” the FDA said in a statement.

Also, mothers that still breastfeed their infants should also avoid medicine with codeine and tramadol as they can possibly harm the babies.

Given the new guidelines, labels on medicine containing the substances will be changed. A new warning will appear on  the drug labels of codeine and tramadol, alerting 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 years.

Similarly, a new contraindication will appear to the tramadol label warning against its use in children younger than 18 years to treat pain after surgery to remove the tonsils and/or adenoids.

These new rules come after the FDA reviewed  several decades of adverse event reports submitted from early 1969 to May 2015. Reports  identified 64 cases of serious breathing problems, including 24 deaths, with codeine-containing medicines in children younger than 18 years.

The FDA  also identified nine cases of serious breathing problems, including three deaths, with the use of tramadol in children younger than 18 years from January 1969 to March 2016. The majority of serious side effects with both codeine and tramadol occurred in children younger than 12 years, and some cases occurred after a single dose of the medicine.

Experts looked at reports coming from mothers that breastfeed their babies and found that in several cases, breastfed infants were suffering breathing difficulties and excessive sleepiness. There was also one reported death.

Several other countries have already restricted the use of codeine medicine.