In addition to well-established safety guarantees like social distancing and face mask use, hand hygiene is an integral component of the response to the emergence of COVID. Practicing hand hygiene by washing hands with soap and water for at least 20 seconds, is a simple and effective way to decrease the spread of pathogens and infections, but, if soap and water are not readily available, the CDC recommends the use of alcohol-based hand sanitizer products that contain at least 60% alcohol (ethanol or isopropanol) in community settings; alcohol-based hand sanitizers used in health care settings should contain 60%–95% alcohol (≥60% ethanol or ≥70% isopropanol).

In order to meet the sudden and significant demand for hand sanitizer, however, some manufacturers opted to use a non-traditional ingredient: methanol. Methanol, per the FDA’s regulation of alcohol-based hand sanitizers as an over the counter drug, is not an acceptable ingredient for use in hand sanitizers. Although methanol can be absorbed through the skin, methanol poisoning through that avenue (otherwise known as transcutaneous transmission) is rare and has been reported under unusual circumstances. The extent and rate of transcutaneous methanol absorption depends on variables such as its form (e.g., vapors, liquid, or solution), contact time, dose, concentration, and size of the exposure area.

That said, inadvertent and/or unintentional ingestion by children and older individuals can occur. Substantial methanol exposure can result in nausea, vomiting, headache, blurred vision, permanent blindness, seizures, coma, permanent damage to the nervous system or death. Although all persons using these products on their hands are at risk, young children who accidentally ingest these products and adolescents and adults who drink these products as an alcohol (ethanol) substitute, are most at risk for methanol poisoning.

Unfortunately, it appears that the use of sanitizer containing methanol has already had an impact. On June 30, 2020, CDC received notification from public health partners in Arizona and New Mexico of cases of methanol poisoning associated with ingestion of alcohol-based hand sanitizers. The case reports followed an FDA consumer alert issued on June 19, 2020, warning about specific hand sanitizers that contain methanol.

CDC and state partners established a case definition of alcohol-based hand sanitizer–associated methanol poisoning and reviewed 62 poison center call records from May 1 through June 30, 2020, to characterize reported cases. Medical records were reviewed to abstract details missing from poison center call records. During this period, 15 adult patients met the case definition. All had ingested an alcohol-based hand sanitizer and were subsequently admitted to a hospital. Four patients died and three were discharged with vision impairment.

Persons should never ingest alcohol-based hand sanitizer and should also avoid use of specific imported products found to contain methanol. As of July 15, 2020, FDA had tested and identified 67 Alcohol-based hand sanitizer products that contain methanol.

As of June 29, the FDA’s list of sanitizers to avoid due to the use of methanol is as follows:

  • UVT hand sanitizer labeled with lot number 0530 and an expiration date of 04/2022.
  • Saniderm Products hand sanitizer labeled with lot number 53131626 and “Manufactured on April/1/20.”
  • All-Clean Hand Sanitizer (NDC: 74589-002-01)
  • Esk Biochem Hand Sanitizer (NDC: 74589-007-01)
  • CleanCare NoGerm Advanced Hand Sanitizer 75% Alcohol (NDC: 74589-008-04)
  • Lavar 70 Gel Hand Sanitizer (NDC: 74589-006-01)
  • The Good Gel Antibacterial Gel Hand Sanitizer (NDC: 74589-010-10)
  • CleanCare NoGerm Advanced Hand Sanitizer 80% Alcohol (NDC: 74589-005-03)
  • CleanCare NoGerm Advanced Hand Sanitizer 75% Alcohol (NDC: 74589-009-01)
  • CleanCare NoGerm Advanced Hand Sanitizer 80% Alcohol (NDC: 74589-003-01)
  • Saniderm Advanced Hand Sanitizer (NDC: 74589-001-01)

The CDC advises that, if consumers have any of the products on the list, they should discontinue use immediately, and the product should be disposed of in hazardous waste containers. The products should not be flushed down a toilet or poured down a drain.

The products are being recalled by the manufacturer or distributor in the United States and the FDA investigation is ongoing.

SOURCES:

https://www.cdc.gov/mmwr/volumes/69/wr/mm6932e1.htm?s_cid=mm6932e1_w

https://www.fda.gov/drugs/drug-safety-and-availability/fda-advises-consumers-not-use-hand-sanitizer-products-manufactured-eskbiochem

https://www.fda.gov/drugs/drug-safety-and-availability/fda-updates-hand-sanitizers-consumers-should-not-use

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6069146/