The U.S. Food and Drug Administration has released an official safety announcement on Thursday, April 20, warning against the use of codeine in children younger than 12 years of age.
What Is Codeine?
Codeine is a narcotic painkiller and cough suppressant with similar effects to morphine and hydrocodone, which are strong opioid medication.
This drug is specifically designed and approved to address coughing and manage little to moderate pain. Like other opioid drugs, codeine binds to the opioid receptors in the brain that are responsible for transmitting pain signals throughout the body. Aside from reducing pain, codeine also induces sedation and drowsiness in patients.
In its statement, the FDA has rounded up a list of codeine-containing drugs to watch out for - such as codeine sulfate, codeine phosphate, Butalbital, Acetaminopen, Tylenol, Promethazine, Prometh VC, Triacin-C, Tuxarin ER, and Tuzistra-XR.
Codeine Adverse Effects
Between January 1969 and May 2015, the FDA has reportedly received 64 reports of life-threatening breathing difficulties related to the use of codeine-containing medicines in children from around the globe. Of those cases were at least 24 deaths in children under the age of 12.
Aside from breathing issues, codeine also causes nausea, vomiting, abdominal pain, constipation, and skin allergies.
There are some people who are "ultrarapid metabolizers" or whose livers process the drugs way too quickly, which is not good because it can lead to dangerously high levels of opioids to build up in the body, Dr. Douglas Throckmorton, the deputy center director for regulatory programs at the FDA's Center for Drug Evaluation and Research, explained.
Tramadol, another opioid painkiller, was also mentioned in the most recent FDA warning.
"Our decision today was made based on the latest evidence and with this goal in mind: keeping our kids safe," Dr. Throckmorton said.
Since it's nearly impossible to identify the "ultrarapid metabolizers" or who may be especially sensitive or at higher risk of adverse events from the said opioid medications, the FDA now calls for stringent labeling requirements for manufacturers of codeine- or tramadol-containing drugs.
Aside from kids under age 12, the FDA also advise against giving codeine to breastfeeding mothers and teenagers (12 to 18 years old) if they are obese or are suffering from either obstructive sleep apnea or severe lung disease, which can further intensify the risks of breathing problems.
The federal drug regulatory agency also encouraged parents and health care practitioners to be mindful and extra-vigilant in reading the labels of any prescription drug before giving it to children.