The FDA is requesting label and packaging changes to improve the safety of certain over-the-counter (OTC) topical antiseptic products.
This is after an ongoing evaluation of continuing reports of infections resulting from antiseptics labeled for preoperative or pre-injection skin preparation.
Topical antiseptics are generally safe products to reduce the number of bacteria on patients’ skin before surgery or injections. However, product contamination occurs when organisms are introduced into the product by improper use.
Manufacturers are being requested to package antiseptics indicated for preoperative or pre-injection skin preparation in single-use containers, meant for a one-time use to one patient. Also, manufacturers are being requested to revise topical antiseptics product labels to indicate whether the drug is a sterile or non-sterile product.
Healthcare professionals and patients are also recommended to not dilute antiseptic products after opening them. Applicators and any unused solution should be discarded after that application.
The FDA also noted that healthcare professionals should consider these topical antiseptics as a possible source of infection when trying to determine the cause of postoperative or post-injection infections.
The FDA is continuing to evaluate the safety issue and will take additional actions as needed.
For more information call or read the full FDA Drug Safety Communication.