FDA acts to protect kids from serious risks of opioid ingredients contained in some prescription cough and cold products by revising labeling to limit pediatric use

The U.S. Food and Drug Administration announced that it is requiring safety labeling changes to limit the use of prescription opioid cough and cold medicines containing codeine or hydrocodone in children younger than 18 years old because the serious risks of these medicines outweigh their potential benefits in this population. After safety labeling changes are made, these products will no longer be indicated for use to treat cough in any pediatric population and will be labeled for use only in adults aged 18 years and older. Labeling for the medications also is being updated with additional safety information for adult use – including an expanded Boxed Warning, the FDA’s most prominent warning - notifying about the risks of misuse, abuse, addiction, overdose and death, and slowed or difficult breathing that can result from exposure to codeine or hydrocodone.

“Given the epidemic of opioid addiction, we’re concerned about unnecessary exposure to opioids, especially in young children. We know that any exposure to opioid drugs can lead to future addiction. It’s become clear that the use of prescription, opioid-containing medicines to treat cough and cold in children comes with serious risks that don’t justify their use in this vulnerable population,” said FDA Commissioner Scott Gottlieb, M.D. “It’s critical that we protect children from unnecessary exposure to prescription cough medicines containing codeine or hydrocodone. At the same time we’re taking steps to help reassure parents that treating the common cough and cold is possible without using opioid-containing products.”

In addition to limiting use in children following a comprehensive assessment of the risks and benefits of these products, labeling for adult-only use of prescription opioid cough and cold medicines that contain codeine or hydrocodone will also now include updated safety information. The new labeling will provide safety warnings on these products that are consistent with the labeling of other opioid-containing drug products, including immediate-release opioid analgesics and extended-release and long-acting opioid analgesics. Information about these required safety labeling changes are being made available to parents and health care professionals through a Drug Safety Communication.

The required safety labeling changes announced today are based on an extensive review of available data and expert advice shared at meetings to explore the pediatric use of opioid-containing cough and cold products. They expand pediatric restrictions put in place last year when the FDA required the addition of the FDA’s strongest warning, called a contraindication, to the labeling of prescription codeine products alerting that codeine should not be used to treat pain or cough in children younger than 12 years due to a specific risk of ultra-rapid metabolism in certain patients. The FDA also held an expert roundtable and convened a meeting of its Pediatric Advisory Committee to look at all the risks associated with the use of codeine- or hydrocodone-containing cough and cold products in children and adolescents younger than 18-years-old. Experts indicated that although some pediatric cough symptoms do require treatment, cough due to a cold or upper respiratory infection typically does not require treatment. Moreover, the risks of using prescription opioid cough products in children of all ages generally outweigh the potential benefits.

Common side effects of opioids include drowsiness, dizziness, nausea, vomiting, constipation, shortness of breath and headache. Parents of children currently prescribed a cough and cold medicine containing codeine or hydrocodone are encouraged to talk to their child’s health care professional about other treatment options. Caregivers should also read labels on non-prescription cough and cold products. Some products sold over-the-counter in a few states may contain codeine or may not be appropriate for young children.

This action is one example of the FDA’s work to further protect patients for whom the risks of opioid products outweigh the benefits. The agency continues its ongoing efforts to reduce the scope of the epidemic of opioid addiction on several fronts, including decreasing exposure and preventing new addiction, supporting treatment for those with opioid use disorder, fostering development of novel pain therapies, and improving enforcement.

The FDA, an agency within the U.S. Department of Health and Human Services, promotes and protects the public health by, among other things, assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.