Welcome to the FDA Drug Safety Podcast for health care professionals from the Division of Drug Information.
On June 16, 2021, FDA warned that symptoms such as headache, nausea, and dizziness can occur after applying alcohol-based hand sanitizers to the skin. These symptoms are likely to have occurred because of vapors from the hand sanitizer, potentially from exposure in enclosed spaces or spaces with poor air circulation. We have received increasing reports of these side effects since the start of the COVID-19 pandemic. Most people experienced minor or minimal effects; however, some cases required treatment by a health care professional.
We are continuing to monitor reports of adverse events that occur with hand sanitizers. At this time, we are not making any changes to the OTC Drug Facts Label but will inform the public if additional information becomes available.
Consumers should use hand sanitizers in a well-ventilated area. If you are using hand sanitizer in an enclosed area such as a car, open a window to improve ventilation until the hand sanitizer is dry and the vapors have cleared. Make sure your hands are completely dry and vapors have cleared before doing any activities involving heat, sparks, static electricity, or open flames. Read and follow the directions and warnings on the OTC Drug Facts Label.
Some hand sanitizers may be contaminated with harmful ingredients so check FDA’s "do-not-use" list to learn more. If you experience side effects from hand sanitizer or if someone accidentally ingests it, contact your health care professional or poison control at 1-800-222-1222. Call 911 if the person has trouble breathing or becomes unconscious.
Store hand sanitizers and all other OTC and prescription medicines up and away and out of children’s reach and sight. Swallowing even a small amount of hand sanitizer can cause alcohol poisoning in children, which may cause serious illness or death.
Health care professionals should use hand sanitizer in a well-ventilated area, especially when using it frequently throughout the day. Also check the FDA’s "do-not-use" list before recommending or using a specific hand sanitizer. Educate consumers about the appropriate use of hand sanitizers, and encourage them to read and follow the directions and warnings on the OTC Drug Facts Label.
We reviewed case reports submitted to FDA and cases from calls to U.S. poison control centers of adverse events after applying alcohol-based hand sanitizers to the skin. Commonly reported symptoms included headache, nausea, and dizziness, likely because of vapors from the hand sanitizer product, and potentially from exposure in enclosed spaces.
For cases reported to FDA in the 11 years between January 1, 2010, and December 31, 2020, we identified 50 cases of serious adverse events. All were reported after March 2020 and coincided with the marked increase in the use of hand sanitizer during the COVID-19 pandemic. Most of the 50 cases were in adults, with four in children.
For cases from U.S. poison control center calls, in the 3 years between January 1, 2018, and December 31, 2020, we identified 299 cases of skin and inhalation or nasal exposures. The number of exposures rose significantly after March 2020 during the COVID-19 pandemic. Most cases were in adults, with children 5 or younger accounting for 12 percent. Most cases resulted in minor or minimal effects; however, some required treatment by a health care professional.
Side effects involving hand sanitizers and other medicines should be reported to FDA’s MedWatch program at www.fda.gov/medwatch.
A link to the full communication detailing specific information for health care professionals and the complete Data Summary can be found at www.fda.gov/DrugSafetyCommunications. If you have drug questions, you can reach us at email@example.com.
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