含苯佐卡因（Benzocaine）出牙止痛凝膠導致嬰幼兒死亡，美國FDA籲停售

可作局部麻醉藥的苯佐卡因，用於治療牙痛及成人的唇疹，惟苯佐卡因可引致罕見的血液疾病，誘發致命的呼吸問題。FDA過去10年曾警告家長要注意用於出牙止痛的產品，並不斷收到相關產品死亡或致病的報告。FDA指出，並沒有證據顯示出牙止痛的產品有效，因此要求下架。

FDA專員戈特利布（Scott Gottlieb）發表聲明稱：「我們呼籲家長、護理人員及零售商聽從忠告，不要使用含苯佐卡因的處方藥物。」FDA警告，倘其他藥廠拒絕盡快配合，將採取法律行動。其中一家主要藥廠「Church and Dwight Co.Inc」表示，將停售旗下4款紓緩出牙疼痛的產品。

連結：美FDA警告 長牙舒緩產品恐導致幼童死亡

苯佐卡因多用作局部麻醉藥，也可用於皮膚病止癢，或創傷方面的止痛，但用於幼童身上易導致幼童出現正鐵血紅蛋白血症（Methemoglobinemia）的情形，雖然機率不大，但嚴重恐致死。

正鐵血紅蛋白血症的主要症狀為：心跳加快、頭暈、呼吸困難、嗜睡、頭痛、臉色蒼白，以及指甲呈現藍色或灰色等。症狀一般在使用後數分鐘內，或者1至2小時後出現，若嬰幼兒出現以上幾種症狀應立即就醫。

聲明稿中提到，FDA將採取監管措施勒令這類產品下架，以及嚴禁該成分添加於幼童的產品上，並提高對該成分相關風險和用途的了解。在此之前，為了維護幼童健康，也呼籲製造商先自行下架含有苯佐卡因的幼童口腔產品。

據美FDA統計，2009年至2017年間，共有119例因苯佐卡因引起的血液疾病，其中造成4死。

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連結：Risk of serious and potentially fatal blood disorder prompts FDA action on oral over-the-counter benzocaine products used for teething and mouth pain and prescription local anesthetics（FDA公告）

he U.S. Food and Drug Administration (FDA) is warning that over-the-counter (OTC) oral drug products containing benzocaine should not be used to treat infants and children younger than 2 years. We are also warning that benzocaine oral drug products should only be used in adults and children 2 years and older if they contain certain warnings on the drug label. These products carry serious risks and provide little to no benefits for treating oral pain, including sore gums in infants due to teething. Benzocaine, a local anesthetic, can cause a condition in which the amount of oxygen carried through the blood is greatly reduced. This condition, called methemoglobinemia, can be life-threatening and result in death.

Due to the significant safety risk of methemoglobinemia, we have urged manufacturers that they should stop marketing OTC oral drug products for treating teething in infants and children younger than 2 years. If companies do not comply, we will take action to remove these products from the market. We have also urged manufacturers of OTC oral drug products containing benzocaine for adults and children 2 years and older to make the following changes to the labels of their products:

• Adding a warning about methemoglobinemia;
• Adding contraindications, FDA’s strongest warnings, directing parents and caregivers not to use the product for teething and not to use in infants and children younger than 2 years; and
• Revising the directions to direct parents and caregivers not to use the product in infants and children younger than 2 years.

We continue to monitor the safety and effectiveness of OTC benzocaine products and intend to take additional actions in the future as needed. We will notify the public about any updates. In addition to our recent actions regarding OTC benzocaine products, we are also requiring a standardized methemoglobinemia warning to be included in the prescribing information of all prescription local anesthetics.

小編評：2014年就有發過警示了，美國FDA再次提醒大家。