FDA requests change to OTC topical antiseptic labels

The FDA has requested label and packaging changes on certain over-the-counter topical antiseptic products to reduce the risk of introducing infection-causing organisms into the product, according to a MedWatch alert.

The agency recommends that topical antiseptics indicated for preoperative or preinjection skin preparation be packaged in single-use containers. The antiseptics are to be applied only once to one patient, and any applicators and unused solution should be discarded immediately thereafter.

“When used properly, topical antiseptics are safe and effective products to reduce the number of bacteria on patients’ skin prior to surgery or injections,” the FDA said in the MedWatch alert. “However, most often, contamination of topical antiseptics occurs when organisms are introduced into the product by users.”

Outbreaks related to topical antiseptics have been reported to the FDA and the CDC, resulting in some product recalls. The outcomes of these contaminations have ranged from localized infections at injection sites to systemic infections resulting in death. The affected products include all common antiseptic ingredients, such as alcohol, iodophors, chlorhexidine gluconate and quaternary ammonium products.

Organisms responsible for the outbreaks included Bacillus cereus, Burkholderia cepacia, Pseudomonas aeruginosa, Achromobacter xylosoxidans, Ralstonia pickettii, Serratia marcescens and Mycobacterium abscessus.