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Triaminic Vapor Patch Recalled Due to Pediatric Ingestion Risks

Yael Waknine

June 20, 2006 — The U.S. Food and Drug Administration (FDA) has notified

consumers regarding the nationwide voluntary recall of a topical cough

suppressant (Triaminic Vapor Patch, made by Novartis Consumer Health), due to

the

potential for serious adverse events associated with its accidental ingestion

by

children.

The over-the-counter vapor patch is comprised of camphor, eucalyptus oil,

and menthol. According to a company news release, all lots are being recalled

in both product lines of mentholated cherry scent and menthol scent.

The product labeling for the patches state that they are intended for use in

children aged 2 years and older. Directions indicate that one or more

patches should be placed on the throat or chest, which allows young children to

r

emove the product and place it in their mouths.

The FDA notes that adverse events associated with swallowing or chewing on

products with camphor or eucalyptus oils have ranged from minor symptoms (eg,

oral burning sensation, headache, nausea/vomiting) to more severe and

potentially life-threatening reactions such as seizures.

Consumers are advised to discard or return the topical cough products to

their point of purchase for a full refund. Those with concerns regarding past

product use may obtain additional recall information online at

_http://www.triaminic.com_ (http://www.triaminic.com/) or by contacting the

company at

1-.

Consumers and healthcare professionals are encouraged to report

patch-related adverse events or quality problems to the FDA's MedWatch

reporting program

by phone at 1-800-FDA-1088, by fax at 1-800-FDA-0178, online at

_http://www.fda.gov/medwatch_ (http://www.fda.gov/medwatch) , or by mail to

5600 Fishers

Lane, Rockville, MD 20852-9787.

Reviewed by D. Vogin, MD

____________________________________

Yael Waknine is a freelance writer for Medscape.

Medscape 2006. © 2006 Medscape