A senior Food and Drug Administration official said over-the-counter products should be added to the agency's limits on use of prescription pediatric cough syrups containing codeine and hydrocodone.

Currently the FDA limits its warning against use in children only to prescription products.

John Alexander, the FDA's deputy director for the division of pediatric and maternal health in the Office of Drug Evaluation in the Center for Drug Evaluation and Research made his comments during a meeting this week of an FDA advisory panel the was examining the next steps the agency should take in deal with the risks codeine-containing pediatric prescription drugs pose to children. At the meeting, held Monday, Sept. 11, the panel overwhelmingly urged the FDA to extend its warning against use of the products from anyone 12 and younger to anyone 18 and younger.

The FDA has been stepping up its oversight of codeine-containing pediatric prescription drugs but oddly the warnings so far have not been applied as strongly to over-the-counter drugs.

"We do think that, ultimately, whatever decision you make today with respect to what you would recommend for the prescription products will be - we will try to apply those consistent determinations to what is done with the OTC products," Alexander told the panel in the lead up to its vote on broadening the FDA's warning.

The FDA in April required warning labels be placed on boxes of codeine-based cough products in the U.S. against their use in children 12 and younger, the requirement made good on a previous advisory panel recommendation made in 2015.

According to CRC Health, an operator of addiction treatment facilities, the most prominent brands of prescription cough syrup containing codeine or hydrocodone have included Robitussin-DAC, Nucofed, Tussi-Organidin and Phenergan. The products have been manufactured by subsidiaries of some of the biggest names in the pharma business, such as Pfizer Inc. (PFE) , Sanofi SA (SNY) , Cardinal Health Inc. (CAH) , and Mylan NV (MYL) , although some have said they will phase out codeine-based pediatric products.

The danger from codeine is particularly acute for a small portion of the population that happens to be prone to "ultra-metabolize" the drug at rates far in excess of the general population. Codeine itself has no direct analgesic effect, but the liver turns it into pain-killing morphine after ingestion. Those that ultra-metabolize the drug can end up with dangerous levels of morphine in their system and suffer respiratory failure. On average, 3% of humans are prone to ultra-metabolize codeine, according studies submitted to the FDA, but the actual percentage varies widely among ethnic groups, with 16% to 28% of Arabs and North Africans prone to ultra-metabolize the drug.

Hydrocodone is a synthetic analgesic that is often derived from codeine and mixed with Tylenol.

The unpredictable nature of codeine metabolization makes it impossible to know what is a safe dose, particularly for children.

The FDA is always watching.
The FDA is always watching.

Washington law firm Hyman, Phelps & McNamara, PC, which represents pharma companies in enforcement matters and drug approvals at the FDA, filed a comment letter with the FDA prior to Monday's meeting and called on the agency to include over-the-counter drug in its labeling requirements.

The FDA so far has required general warning labels only for prescription treatments, not over-the-counter medications. OTC medications require only a warning that codeine products aren't recommended for children with certain health conditions.

If the FDA follows through on Alexander's prediction, it would be "precisely the result we sought in our comment," said Douglas Farquhar, a director at the firm.

Although the federal government has been slow to impose safety requirements on Codeine-based cold remedies, 22 states and the Puerto Rico have acted on their own to prohibit OTC codeine sales within their borders.

In addition to the sizable risk, the medical benefits of treating cough with codeine is considered to be minimal because it only reduces pain and to some extent reduces the urge to cough but does nothing to treat the underlying cause of the cough.

"There no clear benefits and clear evidence of harm," said Stephen Patrick, Assistant Professor of Pediatrics & Health Policy at Vanderbilt University, explaining his vote for the new labeling requirement.

"I find no benefit at all and much more risk in terms of the indication for a symptom that is self-limited and for a self-limited disease" said Erica Liebelt, executive and medical director at the Washington Poison Center.

Jeffrey Brent, a professor at the University of Colorado School of Medicine, said the FDA should do more to discourage use of codeine-based products in the general population, not just children, because there is a higher prevalence of obesity. Obese individuals are more susceptible to sleep apnea and other breathing obstructions that enhance the dangers of having morphine in the bloodstream. 

Wael Sayej, assistant professor of pediatrics at the University of Connecticut School of Medicine, tied the threat of codeine use to the growing problem of opioid addiction. "I don't believe narcotics are a way to treat common colds or allergies," he said. "We have major narcotic epidemic in this country and across the world and fueling the fire doesn't help."

Editor's pick: Originally published Sept. 13

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