Prescription Opioid Cough and Cold Medicines: Drug Safety Communication - FDA Requires Labeling Changes
AUDIENCE: Family Practice, Pediatrics
ISSUE: 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. FDA is 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, the most prominent warning, of the drug labels for prescription cough and cold medicines containing codeine or hydrocodone.
Some codeine cough medicines are available OTC in a few states, and FDA is also considering regulatory action for these products.
FDA is 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.
See the FDA Drug Safety Communication for a list of prescription cough and cold medicines containing codeine or hydrocodone.
BACKGROUND: 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.
RECOMMENDATION:
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.
Read the MedWatch Safety Alert, including a link to the FDA Drug Safety Communication, at:
https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm592053.htm
Codeine及hydrocodone可與其他藥品（例如：抗組織胺或去鼻充血劑）合併使用，用於治療咳嗽、過敏或一般感冒。市面上除了此類藥品，亦有其他非鴉片類藥品及非處方藥可治療此症狀。美國FDA召集外部專家小組進行全面的審查，由於含codeine或hydrocodone之咳嗽或感冒藥使用於小於18歲之兒童，其可能造成錯誤使用、濫用、成癮、藥品過量、呼吸速率降低或呼吸困難、死亡之風險遠高於使用藥品之好處。因此美國FDA要求含codeine或hydrocodone咳嗽或感冒藥之仿單作修訂，限制此類產品僅能用於18歲以上成人。
美國FDA同時也要求新增安全性之資訊於此類藥品仿單之加框警語中，包含使用此類藥品可能造成的錯誤使用、濫用、成癮、過量使用、呼吸速率降低或呼吸困難、死亡之風險。
醫療專業人員應留意美國FDA已改變處方鴉片類止咳和感冒藥之年齡範圍，這些產品不再建議使用於兒童。醫療專業人員應告知家長，感冒和上呼吸道感染通常是可以自行痊癒，不需要藥物治療。如需治療咳嗽，應選擇其他成份之藥品，包含dextromethorphan之非處方藥或benzonatate之處方藥。
家長及照顧者應小心含codeine或hydrocodone 之咳嗽或感冒處方藥使用於小兒會造成嚴重風險，不建議用於小兒。家長們需了解一般感冒之咳嗽不需要藥物治療，若被開立止咳類藥品，請詢問醫療專業人員是否含codeine或是hydrocodone等鴉片類藥品，使用藥品前也需閱讀仿單。若兒童被開立鴉片類藥品，也請立即與醫療人員確認是否需使用其他非鴉片類藥品。如有疑慮，亦請與醫療專業人員討論。
相關訊息與連結請參考FDA網址：
https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm592053.htm
[Posted 1/11/2018]
資料來源：美國FDA之藥物安全警訊
資料提供：台大醫院藥劑部
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