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FDA Seeks to Reduce OTC Antiseptic Related Infections

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Jarod Cassidy4 years ago

The U.S. Food and Drug Administration is requesting that over the counter (OTC) antiseptic manufacturers voluntarily adopt new packaging and labeling procedures to reduce incidents of infection.

OTC Antiseptics and Infection

  • According to MedScape, OTC antiseptics are most often used to reduce the number of bacteria on the skin prior to surgery and injection, or when cleaning a wound.
  • However, according to the FDA, there have been infrequent but ongoing reports of OTC antiseptic products leading to infections and outbreaks.
  • Adverse events cited by the FDA include:

    • 32 cases of bacteremia
    • 16 cases of injections site infections
    • 14 cases of indwelling catheters requiring replacement
    • 10 cases of septic arthritis
    • 7 cases of peritonitis
    • 5 cases of wound infection
    • 4 deaths
  • Previous incidents linked to OTC antiseptic products have resulted in product recalls.

Proposed OTC Antiseptic Changes

  • The FDA is asking that manufacturers of OTC antiseptic products voluntarily take measures to help reduce the number of adverse events linked to the products.
  • The first action would be for manufacturers to package any antiseptics used in pre-injection or preoperative skin preparation in single-use containers.
  • The FDA is also asking that manufacturers label their products as sterile or nonsterile as nonsterile products may still contain microorganisms.
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