FDA Recommends Caution on (pet) Shampoo (distributed by Sogeval Laboratories)

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.

http://www.veterinarypracticenews.com/vet-breaking-news/2011/05/16/fda-recommends-caution-on-shampoo.aspx

Email|Print|ShareDel.icio.usDiggRedditFacebook|Save|LicenseFDA issues alert over adverse events associated with veterinary Douxo Seborrhea Shampoo
May 16, 2011
DVM NEWSMAGAZINE



Rockville, Md—The cause of the adverse events that spurred the latest FDA alert regarding DOUXO Seborrhea Shampoo (0.1% phytosphingosine) are still under investigation, according to Sogeval Laboratories.

The Food and Drug Administration (FDA) issued the alert following two adverse event reports involving dog owners. One of the reports described a woman with severe, pre-existing asthma who had a sudden severe asthma attack while bathing a dog using the product. Another report documented a mild asthma attack from a pet owner following use of the product. The two individuals were described as having preexisting asthmatic conditions.

"Sogeval promptly notified the FDA following all appropriate regulatory protocols and has subsequently been working closely with the agency and the attending veterinarian to investigate the reports," Sogeval says today in a prepared statement.

FDA advises pet owners with asthma or other respiratory conditions to consult with their physician prior to use of DOUXO Seborrhea Shampoo. The product has been marketed in the United States for the last five years, in Europe for six years and sold exclusively through veterinarians.

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