Thursday, August 10, 2006

WellPatch Cough & Cold Vapor Pads Recalled

Yael Waknine

August 2, 2006 — The US Food and Drug Administration (FDA) and The Mentholatum Company have notified consumers regarding the nationwide voluntary recall of a topical cough suppressant (WellPatch Cough & Cold Soothing Vapor Pads) due to the risk for pediatric ingestion associated with its use.

The over-the-counter vapor patch contains camphor, eucalyptus oil, and menthol. According to the package labeling, it may be used in children aged 2 years and older and should be placed on the throat or chest to allow vapors to reach the nose and mouth.

However, such placement also enables young children to remove the product and place it in their mouths, according to an alert sent yesterday from MedWatch, the FDA's safety information and adverse event reporting program.

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. According to a company news release, no serious adverse events have been reported to date.


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