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Codeine and Tramadol Medicines: Drug Safety Communication - Restricting Use in Children, Recommending Against Use in Breastfeeding Women
AUDIENCE: Pediatrics, OB/GYN, Internal Medicine
ISSUE: FDA is restricting the use of codeine and tramadol medicines in children. These medicines carry serious risks, including slowed or difficult breathing and death, which appear to be a greater risk in children younger than 12 years, and should not be used in these children. These medicines should also be limited in some older children. Single-ingredient codeine and all tramadol-containing products are FDA-approved only for use in adults. FDA is also recommending against the use of codeine and tramadol medicines in breastfeeding mothers due to possible harm to their infants.
As a result, FDA is requiring several changes to the labels of all prescription medicines containing these drugs. These new actions further limit the use of these medicines beyond the 2013 FDA restriction of codeine use in children younger than 18 years to treat pain after surgery to remove the tonsils and/or adenoids. FDA is now adding:
‧FDA's strongest warning, called a Contraindication, to the drug labels of codeine and tramadol alerting that codeine should not be used to treat pain or cough and tramadol should not be used to treat pain in children younger than 12 years.
‧A new Contraindication to the tramadol label warning against its use in children younger than 18 years to treat pain after surgery to remove the tonsils and/or adenoids.
‧A new Warning to the drug labels of codeine and tramadol to recommend against their use in adolescents between 12 and 18 years who are obese or have conditions such as obstructive sleep apnea or severe lung disease, which may increase the risk of serious breathing problems.
‧A strengthened Warning to mothers that breastfeeding is not recommended when taking codeine or tramadol medicines due to the risk of serious adverse reactions in breastfed infants. These can include excess sleepiness, difficulty breastfeeding, or serious breathing problems that could result in death.
See the FDA Drug Safety Communication for a data summary, a list of approved drugs containing codeine and tramadol, and additional information.
BACKGROUND: Codeine is approved to treat pain and cough, and tramadol is approved to treat pain.
RECOMMENDATION: Health care professionals should be aware that tramadol and single-ingredient codeine medicines are FDA-approved only for use in adults. Consider recommending over-the-counter (OTC) or other FDA-approved prescription medicines for cough and pain management in children younger than 12 years and in adolescents younger than 18 years, especially those with certain genetic factors, obesity, or obstructive sleep apnea and other breathing problems. Cough is often secondary to infection, not serious, and usually will get better on its own so treatment may not be necessary.
Caregivers and patients should always read the label on prescription bottles to find out if a medicine contains codeine or tramadol. You can also ask your child’s health care provider or a pharmacist. Watch closely for signs of breathing problems in a child of any age who is taking these medicines or in infants exposed to codeine or tramadol through breastmilk. These signs include slow or shallow breathing, difficulty or noisy breathing, confusion, more than usual sleepiness, trouble breastfeeding, or limpness. If you notice any of these signs, stop giving the medicine and seek medical attention immediately by going to an emergency room or calling 911.
Read the MedWatch safety alert, including links to the current and previous Drug Safety Communications, at:
https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm554029.htm
Codeine經美國FDA核可用於止痛與鎮咳；tramadol則經核可用於止痛。此兩種成分藥品可能導致呼吸速率變慢、呼吸困難甚至導致死亡，特別是用於小於12歲之兒童，其發生之風險更高，目前僅核可於成人使用。美國FDA要求這類含codeine及tramadol成分藥品更改仿單，更嚴格規範其適用族群：
1.小於12歲兒童絕對禁忌(contraindication)使用codeine於止痛或鎮咳以及tramadol用於止痛，並於仿單中警示。
2.18歲以下之青少年或兒童絕對禁忌使用tramadol藥品作為扁桃腺(tonsils)或腺樣體(adenoids)切除之術後止痛。
3.12-18歲之青少年若有肥胖、阻塞型睡眠呼吸中止(obstructive sleep apnea)或嚴重肺部疾病，使用codeine或tramadol需特別小心可能會導致嚴重的呼吸問題。
4.哺乳婦女不建議使用codeine或tramadol，因可能會導致接受哺乳之嬰兒出現嚴重藥物副作用，包含嗜睡、嚴重呼吸問題而導致死亡。
醫療專業人員必須知曉美國FDA僅核可tramadol與codeine用於成人。小於12歲之兒童或小於18歲之青少年若需止痛或鎮咳，建議使用非處方藥物(over-the-counter, OTC)或美國FDA核可用於兒童或青少年之藥品，特別是有肥胖、阻塞性睡眠呼吸中止或有其它呼吸問題之病人。咳嗽為感染後之相關症狀，通常可自我痊癒，故不一定需要治療。
照顧者與病人若需確認藥品是否含tramadol或codeine，除了可參考仿單外，也可詢問醫療專業人員。若任何年齡層之兒童或嬰幼兒接觸到此類藥品，請密切觀察有無出現呼吸困難等相關問題，包含呼吸速率變慢、呼吸困難或呼吸不順、混亂、比平時更嗜睡或無力(limpness)。如有發現上述症狀，停止給予藥品，並立即就醫。
相關訊息與連結請參考FDA網址：
https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm554029.htm
[Posted 04/20/2017]
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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