"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 metabolize (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, MD, deputy center director for regulatory programs, Center for Drug Evaluation and Research, in a statement. The problem is that nursing mothers who use codeine or tramadol can pass unsafe levels of opioids to their infants through breastmilk.
The FDA added a "Black Box" warning against using codeine to treat children with tonsillectomy pain in 2013.
The agency on Thursday ordered several alternations in labels to underscore the risks of the drugs to children. Alternative methods for a cough and cold should not contain opioids, especially when used for children under the age of 12.
Tramadol is a prescription drug that is only approved for adults to treat pain, the agency noted. In the safety memo, the agency reported it had collected "64 cases of serious breathing problems, including 24 deaths, with codeine-containing medicines in children younger than 18 years", since 1969.
In Thursday's announcement, the FDA said, "Watch closely for signs of breathing problems in a child of any age who is taking these medicines or in infants exposed to codeine or tramadol through breastmilk".
Indonesia, Brunei to hold state visits in PH next week
Paynor also revealed that even President Duterte realized that it is hard to prepare and host the ASEAN Summit after experiencing it from the other side of the bench.
Children and teens ages 12 to 18 shouldn't take them if they are obese, have obstructive sleep apnea or a weakened respiratory system. Tramadol will now also bear this warning in addition to the other new contraindications and warnings. The agency also found, in a review of the medical literature, a report of an infant who died after being exposed to codeine while breast-feeding.
The move follows Australia's rescheduling of OTC codeine-containing medicines to prescription-only, set to take place on 1 February 2018; New Zealand may be considering doing something similar. These can include excess sleepiness, difficulty breastfeeding, or serious breathing problems that could result in death.
The new warnings did 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.
"We understand there are limited options when it comes to treating pain and cough in children", Throckmorton said.
For more on opioid medications in children, visit the Boston Children's Hospital. The FDA urged parents to carefully read labels of nonprescription cough medicines to avoid codeine and to consult a doctor or pharmacist if needed.