FDA Recommends Caution On Shampoo

Shampoo issued a warning notice by FDA.

The Food and Drug Administration’s (FDA) Center for Veterinary Medicine is alerting veterinarians and 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.

FDA recently received a report of the death of a woman associated with the use of the product on her dog, an event that occurred in March.

The adverse event report describes a woman with severe, pre-existing 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 consult with their physician prior to use of this product. The FDA is investigating this issue and will provide additional information as appropriate.

To report an adverse drug event to FDA, click here.

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