The Food and Drug Administration issued a drug safety announcement April 20 alerting patients and providers of the risks of using codeine in children’s prescription cough and pain medications. The agency was responding to concerns that the drug can cause potentially fatal breathing problems, especially in children younger than 12. FDA is requiring companies to add the strongest form of warning to codeine medications for this age group and is also warning against their use for adolescents.
Makers of over-the-counter (OTC) products that contain codeine, however, cannot add such a warning because FDA has not adjusted the guidelines for how these products can be marketed. Codeine, a Category II controlled substance, can be included in OTC children’s cough products in 28 states and the District of Columbia.FDA controls which OTC products can be marketed through a system of monographs, which are published “recipes” used by product manufacturers that establish conditions under which certain drugs are generally recognized as safe and effective. The monograph for cough medications containing codeine was finalized in 1987 and has not been updated since—even in light of new information on pediatric use. A 2015 review found that 45 OTC products containing codeine from 18 companies were available on store shelves.
FDA has been concerned for years about the safety of codeine in children’s medications. It announced in 2012 that it had received reports of children dying after taking the drug after tonsil or adenoid surgery. The next year, the agency added new warnings to prescription codeine medications to alert health care providers about this risk.
In December 2015, an FDA advisory committee identified 24 deaths and 64 cases worldwide of serious breathing problems in the previous 50 years among children who took medications containing codeine. Twenty-one of those who died were children younger than 12. Children with a particular genetic variation metabolize codeine faster than others, leading to dangerously high levels of derivatives, including morphine, in their blood. The committee voted 28-0, with one abstention, in favor of removing codeine from the OTC monograph for the treatment of cough in children under age 18. The decision came eight months after the European Medicines Agency announced that codeine should not be used to treat cough and cold in children younger than 12 or in children ages 12-18 who have breathing problems. Despite the evidence, FDA has not yet made the change because it must engage in a multistep notice and comment rulemaking process that can take many years to complete.
The fact that codeine can still be marketed in cough medications sold on store shelves illustrates the failings of the current regulatory system for OTC products. FDA can take decisive action to protect patients when a drug is prescribed but not when the same product is sold without a prescription.
FDA is charged with protecting public health and ensuring that the products it regulates are safe and effective. The monograph system—unchanged for 45 years—prevents the agency from taking swift action to carry out that mission. It is time to reform how OTC monographs are regulated.
Stephanie Scarmo is an officer with Pew’s health care products project.