FDANews
FDAnews Drug Daily Bulletin

FDA Requests Labeling Changes for OTC Topical Antiseptic Drugs

Nov. 15, 2013

The FDA is requesting that certain OTC topical antiseptic drugs be repackaged with updated labeling to decrease the risk of infection resulting from their improper use.

“This request is the result of our ongoing evaluation of infrequent but continuing reports of infections resulting from antiseptic products labeled for preoperative or pre-injection skin preparation,” the agency said in a safety alert Thursday.

The agency reviewed 88 cases ranging in severity from localized infection all the way to death from multiple types of dangerous bacteria introduced by users into antiseptics containing alcohol, chlorhexidine gluconate, quaternary ammonium, iodophors and other ingredients.

To mitigate these risk factors, the FDA is recommending that manufacturers package antiseptics in single-use containers and update the labeling such that each vial is used only once on one patient and that applicators and vials are then thrown away. The agency also recommends against diluting the products after opening them.

To read the agency’s recommendations, visit www.fdanews.com/ext/files/11-15-13-Antiseptics.pdf. — Lena Freund

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