May 13, 2011
The FDA’s Center for Veterinary Medicine is alerting pet owners to use caution with the use of an unapproved animal drug product, Douxo Seborrhea Shampoo (0.1% phytosphingosine), distributed by Sogeval Laboratories, Inc. of Coppell, Texas after recently receiving a report of the death of a woman associated with the use of the product on her dog.
The March adverse event report describes a woman with severe, preexisting asthma who had a sudden, severe asthma attack and died while bathing a dog using the product, Douxo Seborrhea Shampoo. A few days later, another asthmatic family member bathed the dog using the same product and experienced a mild asthma attack but recovered.
FDA is advising consumers with asthma or other respiratory conditions to consider consulting with their physicians prior to use of this product.
FDA is currently investigating this serious issue and will provide additional information as appropriate.