藥物警訊

Lidocaine Viscous: Drug Safety Communication - Boxed Warning Required - Should Not Be Used to Treat Teething Pain

AUDIENCE: Consumer, Pediatrics, Family Practice

ISSUE: FDA notified health professionals, their provider organizations and caregivers for infants, that prescription oral viscous lidocaine 2% solution should not be used to treat infants and children with teething pain. FDA is requiring a Boxed Warning to be added to the prescribing information (label) to highlight this information. Oral viscous lidocaine solution is not approved to treat teething pain, and use in infants and young children can cause serious harm, including death.

Topical pain relievers and medications that are rubbed on the gums are not necessary or even useful because they wash out of the baby's mouth within minutes. When too much viscous lidocaine is given to infants and young children or they accidentally swallow too much, it can result in seizures, severe brain injury, and problems with the heart. Cases of overdose due to wrong dosing or accidental ingestion have resulted in infants and children being hospitalized or dying.

BACKGROUND: In 2014, FDA reviewed 22 case reports of serious adverse reactions, including deaths, in infants and young children 5 months to 3.5 years of age who were given oral viscous lidocaine 2 percent solution for the treatment of mouth pain, including teething and stomatitis, or who had accidental ingestions. See further details in the FDA Drug Safety Communication.

RECOMMENDATION: Health care professionals should not prescribe or recommend this product for teething pain. Parents and caregivers should follow the American Academy of Pediatrics' recommendations for treating teething pain.

‧ Use a teething ring chilled in the refrigerator (not frozen).
‧ Gently rub or massage the child's gums with your finger to relieve the symptoms.

FDA is also encouraging parents and caregivers not to use topical medications for teething pain that are available over the counter (OTC) because some of them can be harmful. FDA recommends following the American Academy of Pediatrics' recommendations to help lessen teething pain.

For additional information for health professionals and patients, including the full data summary, see the FDA Drug Safety Communication.

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

FDA提醒大眾，口腔用之2% lidocaine凝膠不建議用於緩解嬰幼兒之長牙疼痛。FDA於此類藥品仿單中加註加框警語以強調此訊息。口腔用之2% lidocaine凝膠未核准於治療兒童長牙的疼痛，嬰幼兒使用可能會造成包含死亡等嚴重危害。

為治療兒童之長牙疼痛將局部止痛劑和藥品塗擦於牙齦是不必要的甚至沒有用，因藥品可能幾分鐘內就會被沖掉。塗擦過多之lidocaine凝膠或不小心吞服過量時，可能會導致癲癇、嚴重大腦損傷和心臟方面問題。目前已接獲因使用錯誤劑量或誤食導致劑量過量而住院或死亡之案例報告。

2014年FDA回顧22起年齡為5個月至3歲半之嬰幼兒因給予口腔用2% lidocaine凝膠治療嘴巴疼痛如長牙和口腔炎，或誤食而發生包含死亡之嚴重副作用案例。

醫療人員不應處方此類產品於長牙止痛。美國兒科醫學會建議家長及其照顧者以下列方式治療長牙疼痛：

1. 給嬰幼兒使用冷藏過之橡皮長牙咬環。
2. 用手指輕輕摩擦或按摩兒童牙齦減緩症狀。

FDA也鼓勵家長或照護者不要使用外用止痛非處方藥品治療長牙疼痛，建議依照美國兒科醫學會之建議以幫助減緩不適感。

相關訊息與連結請參考FDA網址：

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHuma...

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