The Food and Drug Administration (FDA) has issued a safety communication about the potential for side effects when alcohol-based hand sanitizers are applied in enclosed spaces or in places with poor air circulation.
According to the Agency, 50 cases of serious adverse events following application of alcohol-based hand sanitizers were identified in the FDA Adverse Event Reporting System (FAERS) database between January 1, 2010 to December 31, 2020, all of which were reported after March 2020 during the COVID-19 pandemic. Most of the cases were in adults, with 4 in children 5 to 16 years of age. The most common adverse events reported were headache, nausea, and dizziness.
A review of calls made to US poison control centers from January 1, 2018 to December 31, 2020 identified 299 cases of skin and inhalation/nasal exposures to hand sanitizer products resulting in adverse effects. These cases increased significantly after March 2020 during the COVID-19 pandemic. Most of the cases were in adults and resulted in minor or minimal effects; 12% of cases occurred in children 5 years of age and younger. Clinical effects included headache, nausea, and dizziness/vertigo from ethanol.
To reduce exposure to the vapors, the Agency is recommending that hand sanitizers be applied in well-ventilated areas. At this time, there will not be any changes made to the OTC Drug Facts label for hand sanitizers. As some hand sanitizers may be contaminated with harmful ingredients, a review of the FDA’s “do–not-use” list is recommended.
Any adverse effects related to hand sanitizers should be reported to the FDA’s MedWatch program.
FDA warns that vapors from alcohol-based hand sanitizers can have side effects. [press release]. Silver Spring, MD: US Food and Drug Administration; June 16, 2021.