Hand sanitizer products contaminated with methyl alcohol have caused serious adverse events, including hospitalization, blindness, and death.
A Medwatch alert on July 16 reinforced the Food and Drug Administration's June and July warnings of the risk of methanol contamination in hand sanitizers. The products, now in widespread use to protect against infection with the SARS-CoV2 virus, are labeled to contain ethanol (ethyl alcohol) but have tested positive for the toxic methanol (methyl alcohol). The Agency is aware of children and adults ingesting the contaminated products and of significant adverse events, including hospitalization, blindness, and death.
The short slide show below highlights the scope of FDA concerns with use and abuse of the adulterated products which, while being recalled, may still be available at retail outlets or online. Please use the information to alert your patients and office staff.
FDA Recalls. FDA is warning consumers and health care providers that the agency has seen a sharp increase in hand sanitizer products that are labeled to contain ethanol (also known as ethyl alcohol) but that have tested positive for methanol contamination.
Severe Outcomes. FDA is aware of adults and children ingesting hand sanitizer products contaminated with methanol that has led to recent adverse events including blindness, hospitalizations and death.
Consequences of Substantial Methanol Exposure. These range from from GI distress to severe CNS damage and even death.
Extreme Hazard Alert. 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.
Among Primary FDA concerns: The dangers of drinking any hand sanitizer under any conditions. While hand sanitizers with possible methanol contamination are more life-threatening than those that are not contaminated, FDA urges consumers not to drink any of these products.
Among Primary FDA concerns: Certain hand sanitizers that may not contain a sufficient amount of ethyl alcohol or isopropyl alcohol.
Among Primary FDA Concerns: Hand sanitizers that are sold or offered for sale with false and misleading, unproven claims that they can prevent the spread of viruses such as COVID-19, including claims that they can provide prolonged protection (eg, for up to 24-hours).
Among Primary FDA Concerns: Products that are fraudulently marketed as “FDA-approved” since there are no hand sanitizers approved by FDA.
Among Primary FDA Concerns: Products packaged to appear as drinks, candy or liquor bottles, as well as products marketed as drinks or cocktails because their appearance could result in accidental ingestion or encourage ingestion. Children are particularly at risk with these products since ingesting only a small amount of hand sanitizer may be lethal in a young child.
Ongoing Surveillance. Methanol is not an acceptable active ingredient for hand sanitizers and must not be used due to its toxic effects. FDA’s investigation of methanol in certain hand sanitizers is ongoing. Do not use or recommend any products on the FDA list of hand sanitizers with potential methanol contamination. The list is updated daily.
Let Your Patients Know: FDA’s list outlines the information on hand sanitizer labels that patients can use to identify a product that FDA has tested… And found to contain methanol; that is being recalled by the manufacturer or distributor; that is purportedly made at the same facility as products that have been tested and found to contain methanol.
