牙科診所 Benzocaine 口腔止痛藥禁止 2 歲以下嬰幼兒童使用

中華民國衛生福利部食品藥物管理署(以下簡稱食藥署)近日公告,常見於牙科診所使用的口腔止痛藥「Benzocaine(苯佐卡因)」經國際研究機構證實,「Benzocaine」止痛藥可能引發罕見但嚴重的「變性血紅素血症(Methemoglobinemia)」,對於兒童尤其有著更高危險風險,可能傷害大腦甚至致死!

我國食藥署早於 2012 年 9 月 13 日公告要求該成分藥品應於「注意事項」加註「除非在醫療專業人員的建議及監督下,該類藥品勿使用於2歲以下之嬰幼兒」,現自 2019 年 5 月 20 日起,正式明令禁止含有「Benzocaine」成分藥品使用於 2 歲以下嬰幼兒。

美國 FDA 食品和藥物管理局早些年已限制嬰幼童使用,並提出警告說:「這款產品帶來嚴重的安全風險,卻對治療口腔疼痛幾乎沒有任何好處,包括因出牙而導致的嬰兒牙齦疼痛。」而且用作局部麻醉劑,「Benzocaine(苯佐卡因)」可能引發「變性血紅素血症(Methemoglobinemia)」,大幅度減少血液可以攜帶的氧氣含量,並可能危及生命。

食藥署提醒,醫師處方或藥師交付該成分藥品時,應告知病人或其照護者,且貯放此類藥品時,應放置於兒童無法觸及處,以免誤用。此外,醫師也應提醒病人或主要照護者,用藥期間如出現皮膚、嘴唇及甲床顏色呈現蒼白、灰色或藍色、呼吸急促、虛弱、意識混亂、頭痛、頭暈、心跳加速等症狀,應立即就醫。

延伸閱讀:《OTC Benzocaine Teething Products Not Safe for Young Children

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