藥物警訊

Codeine Cough-and-Cold Medicines in Children: Drug Safety Communication - FDA Evaluating Potential Risk of Serious Side Effects

AUDIENCE: Family Practice, Pediatrics, Surgery, Patient

ISSUE: FDA is investigating the safety of using codeine-containing medicines to treat coughs and colds in children under 18 years because of the potential for serious side effects, including slowed or difficult breathing.

Children, especially those who already have breathing problems, may be more susceptible to these serious side effects. In 2013, FDA warned against using codeine in children who recently had surgery to remove their tonsils and/or adenoids.

In April 2015, the European Medicines Agency (EMA) announced that codeine must not be used to treat cough and cold in children under 12 years, and that codeine is not recommended in children and adolescents between 12 and 18 years who have breathing problems, including those with asthma and other chronic breathing problems.

FDA will continue to evaluate this safety issue and will consider the EMA recommendations. Final conclusions and recommendations will be communicated when the FDA review is complete.

BACKGROUND: Codeine is a specific type of narcotic medicine called an opioid that is used to treat mild to moderate pain and also to reduce coughing. It is usually combined with other medications in prescription and over-the-counter (OTC) cough-and-cold medicines.

RECOMMENDATION: Parents and caregivers who notice any signs of slow or shallow breathing, difficult or noisy breathing, confusion, or unusual sleepiness in their child should stop giving their child codeine and seek medical attention immediately by taking their child to the emergency room or calling 911. Parents and caregivers should always read the product label to find out if a medicine contains codeine and talk with their child's health care professional or a pharmacist if they have any questions or concerns. Health care professionals should continue to follow the recommendations in the drug labels and use caution when prescribing or recommending codeine-containing cough-and-cold medicines to children.

Read the MedWatch safety alert, including links to the Drug Safety Communication and previous MedWatch alerts, at:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHuma...

2013年美國FDA曾發布藥品安全警訊，有關曾接受扁桃腺及/或腺樣增殖體切除手術之18歲以下兒童使用codeine止痛發生嚴重副作用，2015年4月歐盟EMA宣布codeine不得使用於小於12歲之兒童，且不建議使用於治療12到18歲兒童之呼吸道症狀，如氣喘或其他慢性呼吸疾病。美國FDA將持續評估及追蹤相關安全議題，且將評估EMA的建議，最後結論及建議將另行公告。

Codeine為鴉片類止痛藥，常用於治療中重度疼痛且可緩解咳嗽症狀。醫師處方時或非處方感冒配方製劑通常會將此藥品與其他藥品併用。

父母或照顧者若發現小孩呼吸微弱、困難、有雜音、精神錯亂或不正常的嗜睡時，應立即停藥並就醫。美國FDA也建議孩童父母及照顧者應仔細詳讀小孩服用的藥品內含成分，必要時應與藥師或醫師諮詢或討論。醫療人員應持續依循藥品仿單建議及應小心謹慎處方含有codeine的感冒藥。

相關訊息與連結請參考FDA網址：http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm453379.htm

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