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Benzocaine Topical Products: Sprays, Gels and Liquids: Risk of Methemoglobinemia
AUDIENCE: Family Practice, Pharmacy, Consumers
FDA notified healthcare professionals and patients that FDA continues to receive reports of methemoglobinemia, a serious and potentially fatal adverse effect, associated with benzocaine products both as a spray, used during medical procedures to numb the mucous membranes of the mouth and throat, and benzocaine gels and liquids sold over-the-counter and used to relieve pain from a variety of conditions, such as teething, canker sores, and irritation of the mouth and gums.
BACKGROUND: Methemoglobinemia is a rare, but serious condition in which the amount of oxygen carried through the blood stream is greatly reduced. In the most severe cases, methemoglobinemia can result in death. Patients who develop methemoglobinemia may experience signs and symptoms such as pale, gray or blue colored skin, lips, and nail beds; headache; lightheadedness; shortness of breath; fatigue; and rapid heart rate. Methemoglobinemia has been reported with all strengths of benzocaine gels and liquids, and cases occurred mainly in children aged two years or younger who were treated with benzocaine gel for teething. The signs and symptoms usually appear within minutes to hours of applying benzocaine and may occur with the first application of benzocaine or after additional use. The development of methemoglobinemia after treatment with benzocaine sprays may not be related to the amount applied. In many cases, methemoglobinemia was reported following the administration of a single benzocaine spray.
RECOMMENDATIONS:
．Benzocaine products should not be used on children less than two years of age, except under the advice and supervision of a healthcare professional.
．Adult consumers who use benzocaine gels or liquids to relieve pain in the mouth should follow the recommendations in the product label. Consumers should store benzocaine products out of reach of children. FDA encourages consumers to talk to their healthcare professional about using benzocaine.
．Read the two Drug Safety Communications below for other specific recommendations for Healthcare Professionals, for Consumers and Caregivers and the Data Summary which supports these recommendations.
FDA is continuing to evaluate the safety of benzocaine products and the Agency will update the public when it has additional information. FDA will take appropriate regulatory actions as warranted.
Healthcare professionals and patients are encouraged to report adverse events, side effects, or product quality problems related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
．Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
．Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
Read the Medwatch safety alert, including links to the Drug Safety Communications and Q&As, at:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm250264.htm
FDA提醒醫療人員和病人，FDA持續收到有關benzocaine引起的變性血紅素血症(methemoglobinemia)的案例報告，這是種嚴重 且可能致死的不良反應。這些案例中包括的benzocaine產品劑型，有在醫療過程中麻醉嘴巴及喉嚨黏膜的噴劑，還有非處方藥中可用來緩解長牙及口腔潰 瘍的疼痛與口腔刺激感的凝膠及液劑。
Methemoglobinemia是一種血中含氧量大量降低的罕見嚴重情形，在大部分嚴重的案例中可能會致死。病人可能會有蒼白、灰或藍色的皮膚、嘴唇 或指甲；頭痛；頭暈；呼吸急促；疲倦及心跳急促的症狀。各種強度的benzocaine的凝膠及液劑皆有引起methemoglobinemia的案例報 告，大多是發生在2歲(含)以下的幼兒用benzocaine凝膠治療長牙疼痛，而症狀通常是在第一次使用或再次使用後數分到數小時發生。新增的噴劑案例 可能不是與使用benzocaine的量相關，因為很多都是在噴第一下之後就發生了。
建議：
* Benzocaine產品除非有醫療人員的建議，否則不應用於2歲以下的幼兒。
* 使用benzocaine凝膠或液劑來緩解口腔疼痛的成人應遵照產品標示使用，且將產品存放在遠離兒童之處，同時，告知醫療人員正在使用該藥品。
* 詳見FDA網站上的2則藥物安全信息，內有其他針對醫療人員、使用者及照護者的特別建議，還有支持此項建議的資訊。
FDA正在持續評估benzocaine產品的安全性，當有新的訊息時會向大眾更新並保證會採取適當的措施。
相關訊息與連結請參考FDA網址：http://www.fda.gov/Safety/MedWatch/SafetyInformation /SafetyAlertsforHumanMedicalProducts/ucm250264.htm
[Posted 04/07/2011]
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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資料來源：藥師週刊（第1730期）
