Topical Antiseptics Require Label Changes, Single-Use Packaging: FDA

In a move designed to reduce the risk of infections, the FDA is requesting label changes for over-the-counter topical antiseptic products, and is asking that they be sold in single-use packaging, instead of multi-use packaging. 

According to an FDA Safety Alert issued this week, the agency indicates that the changes for over-the-counter topical antiseptic products is necessary due to “infrequent but continuing” reports of infections.

Topical antiseptics are primarily used to prep the skin for surgery or injections. The over-the-counter products are often used to swab an area to reduce the amount of bacteria on the skin. Currently, they are available as both single-use and multiple use products.

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The products are not required to be manufactured as sterile and may often become contaminated with bacteria during manufacturing. The products can also become contaminated if users are not careful when administering the product. The FDA hopes that labeling changes and selling the products in single-use packaging only will decrease the risk of infection.

Contamination often occurs when bacteria or other organisms are introduced into the product by users, such as health care professionals or patients, allowing the contaminant into the wound or injection site. In many cases, contamination occurs because users do not follow packaging directions, which greatly increases the chances of infection.

The FDA outlined cases of death and infection that were either reported in medical literature, reported by the U.S. Centers for Disease Control and Prevention (CDC), or found in reports submitted to the FDA. Many of the clinical infections led to product recalls. Four deaths have been reported, resulting from systemic infections.

Other localized infection cases at injections sites were also reported. The FDA outlined five cases of wound infection, seven cases of peritonitis infection, 10 septic arthritis cases, 14 indwelling catheters requiring replacement, 16 cases of injection site infection and 32 cases of bacteremia, or blood infection.

The organisms that were often found during infection included bacillus cereus, Burkholderia cepacia, Pseudomonas aeruginosa, Achromobacter xylosoxidans, Ralstonia pickettii, Serratia marcescens and Mycobacterium abscessus.

In all cases, the confirmed cause was reported to be contaminated antiseptic products. Products included commonly used antiseptic ingredients like alcohol, iodophors, chlorhexidine gluconate, and quaternary ammonium. These products are marketed as solutions, swabs, pads saturated with solution and applicators containing solution.


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