FDA orders codeine and tramadol manufacturers to limit use in kids

cough syrup on geometric table cloth
The FDA is requiring tough new warnings on cough medicines and other drugs containing codeine or tramadol.

The Food & Drug Administration began tracking reports of children suffering dangerous side effects from the pain meds codeine and tramadol in 1969, and now, nearly 50 years later, the agency is finally taking tough action against the manufacturers of those medicines. The FDA is ordering major label changes on prescription drugs containing codeine and tramadol—a requirement that will affect dozens of companies, ranging from giants like Johnson & Johnson to lesser-known names like Vertical Pharmaceuticals of Bridgewater, New Jersey.

On April 20, the FDA issued a consumer alert warning parents that codeine and tramadol, which are both opioids, can cause dangerous breathing problems in children. The agency advised against the use of codeine to treat pain or coughs or tramadol to treat pain in children under 12. It also said nursing mothers should steer clear of the drugs.

In a related safety memo, the FDA explained that all manufacturers of codeine and tramadol would be required to add several new warnings to their labels. They include the FDA’s strongest warning, a “contraindication,” specifying that tramadol should not be used in children who have had their tonsils removed. Both drugs will also carry warnings that children between the ages of 12 and 18 who are obese face an increased risk of breathing problems if they take the drugs.

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. Other affected products include Allergan’s migraine med Fiorinol with codeine and J&J’s tramadol drug Ultracet.

Douglas Throckmorton of the FDA’s Center for Drug Evaluation and Research explained in a press briefing that the problem with these opioid medicines is that some people, including children, metabolize them too rapidly, which can lead to life-threatening depressed breathing. 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. It also identified 9 serious adverse events in children taking tramadol, including three deaths.

The FDA’s action only adds to an increasingly intense crackdown on opioid manufacturers, much of which has been focused on curbing addiction. J&J was already facing scrutiny over its marketing of prescription painkillers, most recently from Sen. Claire McCaskill, who last month requested that the company hand over its own estimates on opioid abuse, details about its marketing strategies and contributions it makes to patient groups, and sales quotas. Mylan, Depomed, Insys and Purdue received the same request.

As for the FDA’s concern about opioid use in children, yesterday’s action may not be its last word on the matter. The agency had already issued warnings in 2013 and 2015, and it says it will continue to monitor safety reports on drugs containing codeine and tramadol. The FDA noted in its safety announcement that in some states, over-the-counter cough and cold medicines containing codeine are available. The agency is considering “additional regulatory action” related to those products.