The US Food and Drug Administration has again warn consumers and health care professionals not to use certain alcohol-based hand sanitisers due to the dangerous presence of methanol, or wood alcohol – a substance often used to create fuel and antifreeze that can be toxic when absorbed through the skin as well as life-threatening when ingested.
The agency has also taken additional action to help prevent certain hand sanitisers from entering the US by placing them on an import alert. The FDA is proactively working with manufacturers to recall products and is encouraging retailers to remove products from store shelves and online marketplaces.
As part of these actions, a warning letter has been issued to Eskbiochem SA de CV regarding the distribution of products labelled as manufactured at its facilities with undeclared methanol, misleading claims –including incorrectly stating that FDA approved these products – and improper manufacturing practices.
The FDA first warned about some of the methanol-containing hand sanitizers being sold in retail stores and online in June. The agency issued a further warning earlier this month about an increasing number of adverse events, including blindness, cardiac effects, effects on the central nervous system, and hospitalisations and death, primarily reported to poison control centres and state departments of health. The agency continues to see these figures rise.
“Practicing good hand hygiene, which includes using alcohol-based hand sanitiser if soap and water are not readily available, is an important public health tool for all Americans to employ. Consumers must also be vigilant about which hand sanitizers they use, and for their health and safety we urge consumers to immediately stop using all hand sanitisers on the FDA’s list of dangerous hand sanitiser products,” said FDA Commissioner Dr Stephen M Hahn. “We remain extremely concerned about the potential serious risks of alcohol-based hand sanitisers containing methanol. Producing, importing and distributing toxic hand sanitisers poses a serious threat to the public and will not be tolerated. The FDA will take additional action as necessary and will continue to provide the latest information on this issue for the health and safety of consumers.”
The agency has posted a do-not-use list of dangerous hand sanitiser products, which is being updated regularly. In most cases, methanol does not appear on the product label. However, methanol is not an acceptable ingredient in any drug, including hand sanitiser, even if methanol is listed as an ingredient on the product label. The FDA’s ongoing testing has found methanol contamination in hand sanitizer products ranging from 1% to 80%.
Importantly, the FDA is urging consumers not to use any hand sanitizer products from the particular manufacturers on the list even if the product or particular lot number are not listed since some manufacturers are recalling only certain – but not all – of their hand sanitiser products. Manufacturers’ failure to immediately recall all potentially affected products is placing consumers in danger of methanol poisoning.
One of the reported deaths is associated with Blumen Hand Sanitiser, distributed by 4e North America and manufactured by 4E Global in Mexico, who recently expanded its recall to include additional lots of its hand sanitiser products. Additionally, the FDA is strongly urging distributors and retailers to stop distributing and selling hand sanitisers manufactured by the firms on the list immediately, even if the particular product is not included in a recall, due to the risk of methanol poisoning.
When identifying hand sanitisers from the FDA’s do-not-use list, consumers should look for one or more identifiers from the list that match the product’s labelling, including:
National Drug Code (NDC) number
If any of the identifiers (name, company, or NDC) match a product on the list, the FDA urges consumers to immediately stop using the hand sanitiser. Dispose of the hand sanitiser bottle in a hazardous waste container, if available, or dispose of as recommended by local waste management and recycling centres. 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 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 sanitiser containing methanol and are experiencing symptoms should seek immediate medical treatment for potential reversal of the toxic effects of methanol poisoning.
The FDA encourages health care professionals, consumers and patients to report adverse events or quality problems experienced with the use of hand sanitisers to FDA’s MedWatch Adverse Event Reporting programme (please provide the agency with as much information to identify the product as possible): Complete and submit the report online; or download and complete the form, then submit the report online; or download and complete the form, then submit it via fax at 1-800- FDA-0178.FDA material