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FDA Drug Safety Communication: FDA requires labeling changes for prescription opioid cough and cold medicines to limit their use to adults 18 years and older

[1-11-2018] The U.S. Food and Drug Administration (FDA) is requiring safety labeling changes for prescription cough and cold medicines containing codeine or hydrocodone to limit the use of these products to adults 18 years and older because the risks of these medicines outweigh their benefits in children younger than 18. We are also requiring the addition of safety information about the risks of misuse, abuse, addiction, overdose, death, and slowed or difficult breathing to the Boxed Warning, our most prominent warning, of the drug labels for prescription cough and cold medicines containing codeine or hydrocodone.

We are taking this action after conducting an extensive review and convening a panel of outside experts. Both of these determined the risks of slowed or difficult breathing, misuse, abuse, addiction, overdose, and death with these medicines outweigh their benefits in patients younger than 18.

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 in 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.

Other Boxed Warnings and Warnings and Precautions will also be added to the label for prescription cough and cold medicines containing codeine or hydrocodone, to be consistent with the safety issues described in the labels of prescription opioid pain medicines. We previously communicated about these safety issues for immediate-release opioid pain medicines and extended-release and long-acting opioid pain medicines. Today’s action is for opioid cough and cold medicines requiring a prescription. Some codeine cough medicines are available OTC in a few states, and we also are considering regulatory action for these products.

We urge health care professionals and patients to report side effects involving opioid cough and cold medicines or other medicines to the FDA MedWatch program, using the information in the “Contact FDA” box at the bottom of the page.

List of Prescription Cough and Cold Medicines Containing Codeine

Active Ingredient(s) Brand Name(s)
codeine, chlorpheniramine Tuxarin ER, Tuzistra XR
codeine, phenylephrine, promethazine Only generics available
codeine, promethazine Only generics available
codeine, pseudoephedrine, tripolidine Triacin C

List of Prescription Cough and Cold Medicines Containing Hydrocodone

Active Ingredient(s) Brand Name(s)
hydrocodone, guaifenesin FlowTuss, Obredon
hydrocodone, pseudoephedrine, guaifenesin Hycofenix, Rezira
hydrocodone, chlorpheniramine Tussionex Pennkinetic, Vituz
hydrocodone, chlorpheniramine, pseudoephedrine Zutripro
hydrocodone, homatropine Only generics available

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