本文摘译自MASSDEVICE 2020年4月20日评论

以下为详文

美国食品和药物管理局（FDA）向消费者和医疗保健专业人士发出警告，含甲醇的洗手液产品，一旦被皮肤吸收就会有毒，如果人体摄入就会危及生命。甲醇是一种通常用于制造燃料和防冻剂的物质，对洗手液产品来说，它是人体不可接受的活性成分。FDA发现，标签标示含乙醇（也称酒精），却被检测出甲醇污染呈阳性的洗手液产品，此类情况正在上升。州政府官员还报告了最近来自成人和儿童摄入含甲醇洗手液产品的不良事件，不良事件包括失明、住院和死亡。

FDA继续警告公众，不要使用下面网址列出的特定产品（共69家产品），FDA正在与制造商和经销商进行沟通关于召回这些危险产品的事宜。FDA还将继续对洗手液产品进行质量检测，包括通过美国边境入境的产品检测，并在网站上保存一份FDA检测和召回的洗手液清单，清单将随着危险产品的不断发现而不断更新。

网站列表部分截图

https://www.fda.gov/drugs/drug-safety-and-availability/fda-updates-hand-sanitzers-methanol

FDA专员Stephen M. Hahn说：“所有的美国人都应该养成良好的手卫生习惯，包括在肥皂和水不易获得的情况下使用含酒精洗手液。令人遗憾的是，有些公司利用冠状病毒大流行期间洗手液需求量激增的有利形势，通过销售含有危险和人体不可接受活性成分的产品，把大伙的生命置于危险之中。消费者和医疗保健提供者都不应再使用含甲醇洗手液。”“FDA依然致力于与制造商、药商、州药剂委和公众合作，加强含酒精洗手液的安全供应。”

今年6月，FDA就Eskbiochem公司生产的含甲醇的产品向消费者发出过警告。从那时起，Eskbiochem公司的几家经销商已经发出自愿召回，FDA还劝告其他公司召回其洗手液产品。

FDA竭力劝告消费者保持谨慎，因为其中一些产品仍然会在零售店或网上购买到。

FDA建议消费者立即停止使用这类洗手液，并将瓶子放在危险废物容器中（若有）处理，或者按照当地废物管理和回收中心的建议进行处理。请勿将这些产品冲入或倒入下水道中，或与其他液体混合。

人体接触甲醇会导致恶心、呕吐、头痛、视力模糊、永久失明、癫痫发作、昏迷、对神经系统永久性损伤或死亡。虽然使用甲醇洗手液来洗手的人有中毒的危险，但意外摄入这些产品的幼儿和饮用这些产品作为酒精（乙醇）替代品的青少年和成人的风险是最大的。接触过含甲醇洗手液并出现症状的消费者应立即就医，以逆转甲醇中毒的毒性作用。

FDA警告含甲醇洗手液比其他洗手液更危及生命的同时，也竭力劝告所有消费者不要饮用任何洗手液产品。这对幼儿尤其是学步儿童尤为重要，学步儿童往往容易被怡人的气味或色彩鲜艳的瓶子所吸引。美国毒物控制中心在冠状病毒大流行期间接到关于误食洗手液的电话不断增加。重要的措施是，成人应将这些产品放在儿童接触不到的地方，并监督幼儿的使用情况。

不要在宠物身上使用洗手液，也不要让宠物吞下洗手液。一旦发现宠物食用了某些有潜在危险的东西，请立即致电兽医或宠物毒物控制中心。

提醒消费者要经常用肥皂和水洗手至少20秒，尤其是在如厕后、吃饭前、咳嗽、打喷嚏或擤鼻涕后。如果肥皂和水不容易买到，美国疾病控制和预防中心建议消费者使用酒精含量至少为60%的洗手液。

原文：

FDA Takes Action to Warn, Protect Consumers from Dangerous Alcohol-Based Hand Sanitizers Containing Methanol

JULY 2, 2020 BY FDA

As part of continued action to protect the American public, the U.S. Food and Drug Administration is warning consumers and health care professionals about hand sanitizer products containing methanol, or wood alcohol — a substance often used to create fuel and antifreeze that is not an acceptable active ingredient for hand sanitizer products and can be toxic when absorbed through the skin as well as life-threatening when ingested. The agency has seen an increase in hand sanitizer products that are labeled to contain ethanol (also known as ethyl alcohol) but that have tested positive for methanol contamination. State officials have also reported recent adverse events from adults and children ingesting hand sanitizer products contaminated with methanol, including blindness, hospitalizations and death.

The agency continues to warn the public not to use specific products listed here and is communicating with manufacturers and distributors of these dangerous products about recalling them. The FDA also continues to quality-test hand sanitizers, including testing products entering the country through the U.S. border, and maintains a list of FDA-tested and recalled hand sanitizers on the agency’s website, which will be continually updated as dangerous products are discovered. https://www.fda.gov/drugs/drug-safety-and-availability/fda-updates-hand-sanitzers-methanol

“All Americans should practice good hand hygiene, which includes using alcohol-based hand sanitizer if soap and water are not readily available. Unfortunately, there are some companies taking advantage of the increased usage of hand sanitizer during the coronavirus pandemic and putting lives at risk by selling products with dangerous and unacceptable ingredients. Consumers and health care providers should not use methanol-containing hand sanitizers,” said FDA Commissioner Stephen M. Hahn, M.D. “The FDA remains committed to working with manufacturers, compounders, state boards of pharmacy and the public to increase the safe supply of alcohol-based hand sanitizers. This includes staying vigilant and continuing to take action when quality issues with hand sanitizers arise.”

In June, the FDA warned consumers about products manufactured by Eskbiochem, which contained methanol. Since then, voluntary recalls have been conducted by several of Eskbiochem’s distributors and the agency is recommending additional companies recall their hand sanitizer products.

The agency urges consumers to be cautious since some of these products may still be found at retail outlets or for purchase online.

The FDA recommends consumers immediately stop using these hand sanitizers and dispose of the bottle in a hazardous waste container, if available, or dispose of as recommended by your local waste management and recycling center. Do not flush or pour these products down the drain or mix with other liquids.

Methanol exposure can result in nausea, vomiting, headache, blurred vision, permanent blindness, seizures, coma, permanent damage to the nervous system or death. Although people using these products on their hands are at risk for methanol poisoning, young children who accidentally ingest these products and adolescents and adults who drink these products as an alcohol (ethanol) substitute are most at risk. Consumers who have been exposed to hand sanitizer containing methanol and are experiencing symptoms should seek immediate medical treatment for potential reversal of toxic effects of methanol poisoning.

While methanol-containing hand sanitizers are more life-threatening than others, the FDA urges all consumers not to drink any hand sanitizer product. This is particularly important for young children, especially toddlers, who may be attracted by the pleasant smell or brightly colored bottles. During the pandemic, poison control centers have had an increase in calls about accidental ingestion of hand sanitizer, and it is important that adults keep these products out of reach of children and monitor young children’s use.

Do not use hand sanitizer on pets or allow pets to swallow hand sanitizer. If you believe your pet has eaten something potentially dangerous, call a veterinarian or a pet poison control center immediately.

Consumers are reminded to wash their hands often with soap and water for at least 20 seconds, especially after going to the bathroom; before eating; and after coughing, sneezing or blowing one’s nose. If soap and water are not readily available, the U.S. Centers for Disease Control and Prevention recommends consumers use an alcohol-based hand sanitizer that contains at least 60 percent ethanol.

The FDA encourages health care professionals, consumers and patients to report adverse events or quality problems experienced with the use of hand sanitizers to FDA’s MedWatch Adverse Event Reporting program (please provide the agency with as much information as possible to identify the product):

Complete and submit the report online, or

Download and complete the form, then submit it via fax at 1-800-FDA-0178.

Consumers, manufacturers or distributors who have questions for the FDA regarding hand sanitizers should email COVID-19-Hand-Sanitizers@fda.hhs.gov.