FDA: Warnings about Side Effects and Contamination with Hand Disinfectants

With a warning, the Food and Drug Administration (FDA) recently attracted some attention, especially in times when hand disinfection is part of everyday life for large parts of the population. The authority warned that symptoms such as headaches, nausea and dizziness can occur after using alcohol-based hand sanitizers on the skin. These symptoms are assumed to have occurred due to vapours from the hand sanitiser, possibly from exposure in enclosed or poorly air-circulated spaces. The FDA reported receiving more reports of these side effects since the beginning of the COVID 19 pandemic. In most cases, the effects have been minor or minimal, but in some cases treatment by health professionals has been necessary. The FDA's recommendation in this context is:

"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."

List of the products not recommended

A look at the list shows that not only alcohol-based products are included. The latest entry concerns an alcohol-free product that actually shows contamination with the Burkholderia cepacia complex, which increasingly concerns us in pharmaceutical quality assurance and quality control.  The list includes 254 entries, with manufacturers from a wide range of countries, also outside the American continent.

The FDA states that it will continue to monitor reports of adverse events associated with hand sanitizers, but will not make any changes to the OTC Drug Facts Label at this time. However, it will inform the public when additional information becomes available.

Summary of the known cases

Reports submitted to the FDA and to poison control centres of adverse reactions and effects following the application of hand sanitisers containing alcohol were reviewed by the FDA. Symptoms such as headache, nausea and dizziness, likely due to the vapours from the hand sanitizer and possibly due to indoor exposure, were among the more common effects reported. According to the FDA, this results from the summary of reports over a period of about 10 years:

"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."

On the one hand, the available data suggest that there could be a causal link with the much more frequent use of hand disinfectants by untrained staff/people during the pandemic. At the same time, barriers to the production and marketing of disinfectants have been relaxed in many countries to counteract the lack of available products.

To find out more, please see "FDA warns that vapors from alcohol-based hand sanitizers can have side effects".