Antiseptic products infection risk prompts FDA request for label change

Published: 15-Nov-2013

US FDA wants label changes and single-use packaging for some OTC topical antiseptic products


The request is the result of ongoing evaluation of reports of infections resulting from antiseptic products labeled for preoperative or pre-injection skin preparation. Contamination of topical antiseptics can occur when organisms are introduced into the product by users and the FDA is urging healthcare professionals and patients to follow all label directions to decrease the chances of infection.

To further reduce the risk the FDA is requesting that manufacturers package antiseptics indicated for preoperative or pre-injection skin preparation in single-use containers. Applicators and any unused solution should be discarded after the single application.

The FDA is also asking manufacturers to voluntarily revise product labels for topical antiseptics to indicate whether the drug is manufactured as a sterile or non-sterile product, to assist healthcare professionals in making informed decisions about using these products.

The FDA has reviewed reports of four deaths, five cases of wound infection, seven 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. Organisms implicated in the outbreaks included Bacillus cereus, Burkholderia cepacia, Pseudomonas aeruginosa, Achromobacter xylosoxidans, Ralstonia pickettii, Serratia marcescens, and Mycobacterium abscessus.

The FDA says it is aware of two mechanisms by which contamination of topical antiseptic products may occur: Extrinsic contamination – which appears to be the more common mechanism – when micro-organisms are introduced into the antiseptic by the user. This may be 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; and intrinsic contamination, which occurs during the manufacturing process. In these cases, micro-organisms have been isolated from pharmaceutical water supplies and non-sterile manufacturing environments.

For more information about this issue visit http://www.fda.gov/Drugs/DrugSafety/ucm374838.htm

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