Drug Safety Update: Coronavirus

CITY OF WASHINGTON (June 23, 2021)—The U.S. Food and Drug Administration (FDA) continued to take action in the ongoing response to the COVID-19 pandemic:

  • FDA issued a Drug Safety Communication for hand sanitizers, warning that symptoms such as headache, nausea, and dizziness can occur after applying alcohol-based hand sanitizers to the skin and inhaling the vapors that linger. FDA 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. While the majority of cases resulted in minor or minimal effects, some cases resulted in treatment by a health care professional. These reports have occurred after the start of the COVID-19 pandemic. Consumers should use hand sanitizer in a well-ventilated area.
  • As part of the FDA’s effort to protect consumers, on May 18, 2021, the agency issued a warning letter to Umbrella for selling an unapproved product with unproven COVID-19 claims. Consumers concerned about COVID-19 should consult with their health care provider.
  • Testing updates:
    • As of today, 388 tests and sample collection devices are authorized by the FDA under emergency use authorizations (EUAs). These include 278 molecular tests and sample collection devices, 82 antibody and other immune response tests and 28 antigen tests. There are 52 molecular authorizations and one antibody authorization that can be used with home-collected samples. There is one molecular prescription at-home test, three antigen prescription at-home tests, five antigen over-the-counter (OTC) at-home tests and two molecular OTC at-home tests.
    • The FDA has authorized 11 antigen tests and three molecular tests for serial screening programs. The FDA has also authorized 541 revisions to EUA authorizations.

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