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。”
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.