United States: The United States FDA Recommends Labeling Changes For Cough And Cold Drugs Containing Opioids To Protect Children

On January 11, 2018, the United States Food and Drug Administration (US-FDA) 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 of age because the serious risks of these medicines outweigh their potential benefits in this population57. 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 is being updated with additional safety information for adult use – including an expanded Boxed Warning, 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.

The FDA Commissioner said that given the epidemic of opioid addiction and knowing that any exposure to opioid drugs can lead to future addiction, the agency is concerned about unnecessary exposure to opioids, especially in young children.. It has become clear that the use of opioid-containing prescription medicines to treat cough and cold in children comes with serious risks that does not justify their use in this vulnerable population; making it critical to protect children from unnecessary exposure to such medicines.

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 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 are based on an extensive review of available data and expert advice. The expanded pediatric restrictions were put in place last year58, when the FDA required the addition of its 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 of age. 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. Some products sold over-the-counter in a few states may contain codeine and may not be appropriate for young children.

Through another Drug Safety Communication59, the agency has notified health care professionals, parents and caregivers the following:

  • Health care professionals should be aware that FDA is changing the age range for which prescription opioid cough and cold medicines are indicated. These products will no longer be indicated for use in children, and their use in this age group is not recommended. Health care professionals should reassure parents that cough due to a cold or upper respiratory infection is self-limited and generally does not need to be treated. For those children in whom cough treatment is necessary, alternative medicines are available. These include over-the-counter (OTC) products such as dextromethorphan, as well as prescription benzonatate products.
  • Parents and caregivers should be aware that prescription opioid cough and cold medicines that include codeine or hydrocodone should not be used for children. Codeine and hydrocodone are narcotic medicines called opioids and may carry serious risks when used in children. It is important for parents and caregivers to understand that a cough due to a common cold often does not need medicines for treatment. If a cough medicine is prescribed, ask your child's health care professional or a pharmacist if it contains an opioid such as codeine or hydrocodone. Always read the labels on prescription bottles. If the medicine prescribed for your child contains an opioid, talk to your child's health care professional about a different, non-opioid medicine, or if you have any questions or concerns.

Codeine and hydrocodone are available in combination with other medicines, such as antihistamines and decongestants, in prescription medicines to treat coughs and symptoms associated with allergies or the common cold. Other non-opioid prescription and OTC medicines are available to treat these symptoms.

List of Prescription Cough and Cold Medicines Containing Codeine

Active Ingredient(s)
codeine, chlorpheniramine
codeine, phenylephrine, promethazine
codeine, promethazine
codeine, pseudoephedrine, tripolidine

List of Prescription Cough and Cold Medicines Containing Hydrocodone

Active Ingredient(s)
hydrocodone, guaifenesin
hydrocodone, pseudoephedrine, guaifenesin
hydrocodone, chlorpheniramine
hydrocodone, chlorpheniramine, pseudoephedrine
hydrocodone, homatropine

Conclusion:

This action of FDA is to 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.

Footnotes

57. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm592109.htm

58. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm553285.htm

59. https://www.fda.gov/Drugs/DrugSafety/ucm590435.htm

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