FDA Seeks Changes to OTC Antiseptics to Prevent Infection

Megan Brooks


November 14, 2013

An ongoing evaluation of "infrequent but continuing" reports of infections resulting from over-the-counter (OTC) antiseptic products used prior to surgery or injections has prompted the US Food and Drug Administration (FDA) to request label and packaging changes to enhance safety, the agency said yesterday.

The FDA is requesting that manufacturers voluntarily package OTC antiseptics indicated for preoperative or preinjection skin preparation in single-use containers and to label their products as sterile or nonsterile.

"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 notes in a Drug Safety Communication posted on its Web site.

"However, most often, contamination of topical antiseptics occurs when organisms are introduced into the product by users. Therefore, health care professionals and patients should follow all label directions to decrease the chances of infection," the statement reads.

A Range of Infections, 4 Deaths

The FDA says infections tied to the use of contaminated topical antiseptics have been reported in the medical literature and to the Centers for Disease Control and Prevention (CDC) and to the FDA, leading to some product recalls, as reported by Medscape Medical News.

Reported infections have ranged from localized infections at injection sites to systemic infections that resulted in death. The FDA says it has reviewed reports of 4 deaths, 5 cases of wound infection, 7 cases of peritonitis, 10 cases of septic arthritis, 14 cases of indwelling catheters requiring replacement, 16 cases of injection site infection, and 32 cases of bacteremia.

"These infections have been confirmed to be caused by contaminated antiseptic products," the FDA says.

The affected products included all commonly used antiseptic ingredients, including alcohol, iodophors, chlorhexidine gluconate, and quaternary ammonium products. These products are sold as solutions, swabs, pads saturated with a solution, and applicators containing a solution. They are currently available as both single-use and multiple-use products.

The organisms implicated in the outbreaks included Bacillus cereus, Burkholderia cepacia, Pseudomonas aeruginosa, Achromobacter xylosoxidans, Ralstonia pickettii, Serratia marcescens, and Mycobacterium abscessus.

The FDA notes that OTC topical antiseptics used before injection or surgery are not required to be manufactured as sterile. If a product does not have "sterile" stated on the label, healthcare professionals should be aware that they are using a nonsterile product, the agency advises.

"A 'nonsterile' label does not mean the product contains harmful bacteria, but rather that its contents have not been sterilized, or treated with a process during manufacturing to eliminate all potential microorganisms," according to the FDA statement.

Monitoring for Microbial Contamination Continues

For now, the FDA is not proposing a requirement that these products be manufactured as sterile, but says it will "continue to monitor and evaluate risks associated with microbial contamination."

The FDA says OTC extrinsic contamination of topical antiseptics, when microorganisms are introduced into the antiseptic by the user, "appears to be the more common mechanism.... This may occur as a result of dilution of the product with contaminated water, failure to use appropriate aseptic techniques during handling, or storing antiseptic solutions under non-sterile conditions," the agency says.

Intrinsic contamination, which occurs during the manufacturing process, is also possible. "In these cases, microorganisms have been isolated from pharmaceutical water supplies and non-sterile manufacturing environments. Once introduced into the product during manufacturing, these organisms may remain viable and multiply," the agency notes.

To reduce the chances of patient infection, the FDA asks health professionals to ensure that these products are used according to the directions on the label. They advise that preoperative or preinjection topical antiseptics packaged in single-use containers only be applied at 1 time to a single patient. Applicators and any unused solution should be discarded after that application. They also advise against diluting topical antiseptic products after opening.

The FDA also encourages providers to consider topical antiseptics as a possible source of infection when trying to determine the cause of postoperative or postinjection infections.

To report adverse events involving topical antiseptics, contact MedWatch, the FDA's safety information and adverse event reporting program, by telephone at 1-800-FDA-1088; by fax at 1-800-FDA- 0178; online at https://www.accessdata.fda.gov/scripts/medwatch/medwatch-online.htm; with postage-paid FDA form 3500, available at http://www.fda.gov/MedWatch/getforms.htm; or by mail to MedWatch, 5600 Fishers Lane, Rockville, Maryland 20852-9787.


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