FDA Warning On Codeine Cough Syrup

Thursday, the FDA announced the strongest level of medication warnings regarding children using opioid pain-killers. Medications with codeine and tramadol now require labels stating to only give to children older than 12. And pregnant women or children 12-18 years old should limit the use.

In 2015 the FDA launched a safety review investigating the risks of using the two opiate drugs. Currently, codeine treats cough symptoms and pain, and tramadol is to treat pain.

The study found that these two medications are a risk for children under 12. Some risks are issues with breathing and even death, and those 18 or younger with breathing problems should not use them.

The FDA’s center director, Douglas Throckmorton, states they have limits on options when treating children’s pain and cough, and this change brings questions for parents and doctors. However, the decision is based on recent studies intended to keep children safe.

Codeine already has a “black box warning” added by the FDA in 2013. The notice says not to use the drug to treat children’s pain after removing their tonsils. Now, Tramadol will carry the same warning in addition to the newest findings.

These only apply to prescription drugs, while some are available over the counter. The FDA is reviewing other regulations that may apply to over-the-counter medications with codeine.

In the past 5 years, both the European Medicines Agency and Health Canada have added similar warnings surrounding codeine.

However, unlike codeine, Tramadol wasn’t approved by the FDA for children. But in 2015 they said that it was probably being used in children off-label.

In 2016, the American Academy of Pediatrics was encouraging doctors to stop prescribing children codeine.

FDA Warning