A similar search for tramadol identified nine cases worldwide of respiratory depression in children 18 years of age, including three deaths; respiratory depression typically occurred within the first 24 hours of drug administration.
In light of these narcotics that are fatal to kids, the FDA has been evaluating the use of codeine and tramadol in children ages 17 and below since 2015.
"We require 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)", said Douglas Throckmorton, deputy director at Center for Drug Evaluation and Research.
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.
According to Med Page Today, the FDA released a statement warning the public, especially parents against using medicine that contains codeine or tramadol for children under the age of 12.
The FDA said Warning labels on medications with codeine or tramadol will be strengthened to reflect these dangers. the agency said Nursing mothers should also avoid using these drugs.
The FDA officials also urged parents to check the ingredients of over-the-counter medications and to be extremely careful of giving children any that contain codeine. These can include excess sleepiness, difficulty breastfeeding, or serious breathing problems that could result in death. The agency cited evidence that the drugs could cause dangerously slowed breathing in some children, which could lead to death.
The FDA is now advising health care professionals that the use of codeine or tramadol containing medicine is only FDA-approved for adult usage as it has proven to be fatal to kids. Even in older children who have colds, coughs are generally mild and go away in a few days, so they may not need to take any medicine.
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.
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. "They can cause a lot of harm when they're not", said the FDA's Dr. 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.
For more on opioid medications in children, visit the Boston Children's Hospital.