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FDA Warns Consumers Not to Use Triaminic Vapor Patch

Possible Safety and Health Risks to Children

Jun 19, 2006 | www.fda.gov

The U.S. Food and Drug Administration (FDA) today is warning consumers not to use the Triaminic Vapor Patch marketed by Novartis Consumer Health due to reports of serious adverse events associated with accidental ingestion by children. Novartis Consumer Health also announced today that it is conducting a nationwide voluntary recall of all Triaminic Vapor Patch products.

FDA is advising consumers who have used the product and have concerns or questions to contact their physician or health care practitioner. In addition, the company is advising consumers to either discard or return the product to their point of purchase for a refund.

Triaminic Vapor Patch contains camphor, eucalyptus oil, and menthol. The reported side effects from swallowing or chewing on products containing camphor or eucalyptus oils vary from minor symptoms, such as a burning sensation in the mouth, headache, nausea and vomiting, to more severe and life-threatening reactions, such as seizures.

Triaminic Vapor Patch is labeled as a cough suppressant for children two (2) years of age and older. The directions on the label indicate the patch is to be applied to the throat or chest to allow the vapors to reach the nose and mouth. Multiple patches can be applied at one time. Once applied, the patch would be within close reach for a child to remove and place the product in his/her mouth. The Vapor Patch is a topical cough product applied externally and is not for oral consumption.

The product is sold over the counter at pharmacies and retail outlets nationwide.

Any adverse reactions experienced with the use of this product, and/or quality problems should be reported to the FDA's MedWatch Adverse Event Reporting program online at www.fda.gov/MedWatch/report.htm, by phone (1-800-FDA-1088), or by returning the postage-paid FDA form 3500, which may be downloaded from www.fda.gov/MedWatch/getforms.htm, by mail to MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787 or fax (1-800-FDA-0178).