FDA issues alert over adverse events associated with veterinary Douxo Seborrhea Shampoo

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.

Sogeval reports that assay results from retained samples of the production lot indicate the product is within specification.

FDA says it is investigating these reports and will provide additional information as appropriate.