In addition, a new Warning is being added to the drug labels of codeine and tramadol to recommend against their use in adolescents between aged 12 and 18 years who are obese or have conditions such as obstructive sleep apnea or severe lung disease, which may increase the risk of serious breathing problems.
"We are requiring these changes because we know that some children who received codeine or tramadol have experienced life-threatening respiratory depression and death because they metabolise (or break down) these medicines much faster than usual (called ultra-rapid metabolism), causing dangerously high levels of active drug in their bodies", said Douglas Throckmorton, M.D., deputy center director for regulatory programs, Center for Drug Evaluation and Research.
Furthermore, the FDA also added that children ages 12 to 18 should also be warned against the use of medicine codeine or tramadol. Drugs containing codeine already carry a black-box warning against using it to treat pain in children who have their tonsils removed.
Some of the products containing these drugs are only available by prescription, but some over-the-counter cough medicines contain codeine.
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. Alternative methods for a cough and cold should not contain opioids, especially when used for children under the age of 12.More news: Soyuz space capsule carrying American, Russian blasts off
The FDA is reminding healthcare professionals that tramadol and single-ingredient codeine medications are only FDA-approved for adult use. They include the FDA's strongest warning, a "contraindication", specifying that tramadol should not be used in children who have had their tonsils removed. Codeine is often combined with acetaminophen in prescription pain medicines and cough syrups, the agency said. Canadian regulators also recently completed a safety review for tramadol with similar findings to the FDA's.
Almost 1.9 million kids aged 18 or younger received a prescription for a codeine-containing medication in 2014, and almost 167,000 were prescribed a medication containing tramadol, the FDA said. In all cases, if the medicine contains codeine or tramadol, parents should consult a health care provider before giving their children the medicines or taking them when nursing. The FDA urged parents to carefully read labels of nonprescription cough medicines to avoid codeine and to consult a doctor or pharmacist if needed.
"These medicines should also be limited in some older children".
Conclusively, parents should actively check for any warning labels on medication that they plan to give to their children.