The government said it would ban the use of tramadol, a narcotic analgesic drug, for children under the age of 12, just as the U.S. Food and Drug Administration did so last year.
The prohibition will apply both to the single therapy of tramadol and combinations with acetaminophen. After collecting opinions from pharmaceutical companies, the health authorities plan to change “usage precautions” collectively, the government said.
The Ministry of Food and Drug Safety (MFDS) said on Tuesday that it would add new statements in the usage precautions of 291 tramadol-containing drugs.
The new statements or phrases will include, “Do not administer the drug to children under the age of 12,” “Do not administer the drug under 18 who underwent tonsillectomy or adenoidectomy,” “Take caution in combination therapy with central nervous system inhibitors that contain benzodiazepine drugs or alcohol,” “Possibility of hypoglycemia,” “Pure narcotic antagonists do not restrain tramadol inhibition.”
The changes in the usage precautions will apply to all of the tramadol-active drugs, including the original developer Janssen Korea’s Ultracet and generics. New warnings reflect the FDA’s April ban of the drug for children under 12 and Janssen Korea’s additional information about the safety and efficacy.
Last year, the FDA warned that the administration of the drug to children under 12 raised the risk of respiratory depression and recommended that tramadol should be added to the drug prohibition list.
In December, the MFDS gave a notice that it would change tramadol’s approval conditions and collected opinions from drugmakers.
Based on Janssen Korea’s information on safety and efficacy of tramadol, the government had drugmakers reflect additional precautions as well. They are “Caution in combination therapy with central nervous system inhibitors that contain benzodiazepine drugs or alcohol,” “Possibility of hypoglycemia,” and the statement that “pure narcotic antagonists do not restrain tramadol inhibition.”
“We are to unify the FDA’s safety information and changes in approval conditions for usage precautions, requested by Janssen Korea. If the original developer changes approval conditions, we collectively make adjustments to approval conditions for generic drugs,” a ministry official said.
Drugmakers can submit their opinions about the government’s plan to change approval conditions for tramadol by Feb. 14.