Big Drug Makers Could Face More Pressure on Codeine Remedies for Kids
An interesting decision on medicine forthcoming.

Few things tug at the heartstrings of a parent more than listening to a young child struggle through the night with a debilitating cough.

Most parents wouldn't think twice before driving to the closest pharmacy to pick up a bottle of cough syrup to help a daughter or a son get a little peace from the hacking and some rehabilitative sleep. But maybe they should think twice--there's a chance the remedy could do more harm than cough and congestion ever will.

The safety of pediatric cough remedies is one that U.S. drug regulators have struggled with for years and beginning Monday, Sept. 11 they'll try to make a little more progress when the Food and Drug Administration holds a two-day meeting in Rockville, Md. to examine what the FDA's next steps should be in overseeing prescription cough products containing codeine and hydrocodone for use in children.

Codeine has been used as a painkiller and cough remedy for more than 50 years. And at the FDA's last count, there were more than 45 pediatric cough remedies, both prescription and over-the-counter, listed with the agency that have been produced by more than 18 manufacturers containing codeine or hydrocodone, a synthetic analgesic that is often derived from codeine and mixed with Tylenol.

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.

Codeine-containing cough syrups have been implicated in the growing concern about opioid addiction-a concoction known as Purple Drank or "sizzurp"--first popularized in Houston's rap scene--calls for mixing massive amounts of codeine cold remedy with Sprite. But the FDA's focus in the current meetings will be safety concerns surrounding legitimate use of the medications, namely that children can suffer respiratory distress or death when they are directly administered doses of cough syrup containing codeine or hydrocodone, or ingest them indirectly while breastfeeding.

According to a 2015 study by the FDA, 64 cases of severe respiratory depression had been reported since 1965 in children who had used codeine or codeine-containing products and 24 deaths. Of those deaths, 21 were in children younger than 12.

A chat with a key Johnson & Johnson executive. 

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. 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.

"I believe it's important that parents and healthcare providers have the best information available to inform the decisions they make about a child's health," FDA Commissioner Scott Gottlieb said in August when the the coming week's meeting was announced. "There are few more common decisions that parents and providers are asked to make than the question of how to appropriately treat a child's cough and cold symptoms."

Globally, government officials have been discouraging the use of codeine-based pediatric products since 2011 when the World Health Organization deleted codeine from its list of essential medications for children. The FDA first took action in 2012 when it issued a safety alert regarding the use of codeine after surgery to remove tonsils and adenoids. European regulators followed with their own recommendation against use of codeine for treatment of pain in children and breastfeeding mothers. In March 2015, Europe added codeine-based cough syrups to the recommendation.

A month later an FDA advisory committee recommended that warning labels detailing the risks be added to the boxes of codeine-based pediatric cough products in the U.S. and in April of this year the FDA followed through.

Now the FDA is mulling what to do next. Already it has been urged to ban codeine-based pediatric products entirely. The American Academy of Pediatrics appeared to do that in an October 2016 report detailing the risk of the products. Although the report itself simply called for more research and did not call for outright ban, the preference for a ban was clear from the title: Codeine: Time to Say "No."

The FDA solicited comments for the upcoming meeting but got a tepid response. Washington law firm Hyman, Phelps & McNamara, PC, which represents pharma companies in enforcement matters and drug approvals at the FDA, filed the only comment letter with the FDA calling on the agency to include over-the-counter drug in its labeling requirements.

Douglas B. Farquhar, a director at the firm, said 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. "It's completely counter-intuitive that there be contradiction labeling required on a prescription product that at least is being administered under direction of a doctor while the over-the-counter version doesn't require the same notice to the consumer."

Farquhar noted that 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. "It's a very odd situation," he said. "I can think of no other pediatric drug where so many states have said sales should be prohibited and the FDA has taken no similar action."

Farquhar said that the prescription drugmakers would likely support tougher restrictions on codeine products' use if the restrictions also applied to over-the-counter treatments.

"My suspicion is that the companies selling these products are willing to defer to the FDA in terms of regulations," Farquhar said. "What companies are looking for is a level playing field. Once they have that, they'll probably be OK with whatever restrictions are put on a drug like codeine."

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