Welcome to the FDA Drug Safety Podcast for health care professionals from the Division of Drug Information.
On November 2, 2021, FDA warned that getting alcohol-based hand sanitizer in the eyes from splashing or touching the eyes after use of hand sanitizer can result in serious injury, including severe irritation and damage to the surface of the eye. Eye exposure to hand sanitizer has been reported in all age groups; however, it has occurred most often in children. Such eye injuries have become much more frequent, likely due to the marked increase in the use of alcohol-based hand sanitizer during the COVID-19 pandemic.
We are continuing to monitor safety with use of alcohol-based hand sanitizers. The Drug Facts label for these hand sanitizers currently warns that the product should not be used in or near the eyes. At this time, we are not making any changes to the Drug Facts label but wanted to make the public aware of this growing safety issue, and we will follow up if additional information becomes available.
Consumers should store alcohol-based hand sanitizers and all other over-the-counter (or OTC) and prescription medicines up and away and out of children’s reach and sight.
Health care professionals should urge patients who get alcohol-based hand sanitizer in their eye to immediately and thoroughly rinse their eyes under gently running water such as from a sink tap, water bottle, or emergency shower for at least 15 to 20 minutes. After rinsing, if symptoms such as redness, pain, irritation, visual impairment, blurred vision, or light sensitivity persist, advise the patient to seek an urgent eye examination.
Check FDA’s “do-not-use” list before recommending or using a specific hand sanitizer, as some hand sanitizer may contain or be contaminated with harmful ingredients. Counsel 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 cases from calls to U.S. poison control centers and publications in the medical literature of serious side effects resulting from eye exposure to alcohol-based hand sanitizers. For cases from U.S. poison control center calls between January 1, 2018, and April 30, 2021, we identified 3,642 cases of side effects resulting from eye exposure to these hand sanitizers. The most common side effects were eye irritation or pain and red eye or conjunctivitis. This included 58 cases of a more serious injury to the surface of the eye. All 58 cases were treated by rinsing with water or saline with 26 also receiving antibiotics. Half of the 58 cases occurred in children and teens 19 years and younger.
We reviewed two publications describing a total of 18 cases of eye exposure to alcohol-based hand sanitizer in children younger than 18 years, which required treatment in a hospital or by a health care professional. In 10 cases, the child had damage to the surface of the eye.
Side effects involving hand sanitizers and other medicines should be reported to FDA’s MedWatch program at www.fda.gov/medwatch.
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