Marshals Seize Drug After Company Refuses to Recall It

U.S. marshals acting for the FDA seized two lots of Miami-based SEI Pharmaceuticals’ Xiadafil VIP tablets that the company refused to recall at the request of the agency.

“Today’s seizure action shows that FDA will take enforcement action to protect the public from dietary supplements that contain prescription drug ingredients that are potentially harmful to consumers,” Margaret Glavin, associate commissioner of the FDA’s Office of Regulatory Affairs, says in a written statement.

The FDA’s chemical analysis of Xiadafil VIP tablet lots 6K029 and 6K029-SEI found that the product contained an undeclared ingredient, hydroxyhomosildenafil, the agency’s statement says. The chemical is similar to sildenafil, the active ingredient in Viagra (sildenafil citrate), which is approved to treat erectile dysfunction (ED).

The agency says it has not approved Xiadafil VIP for ED or any other drug use, and the product’s safety and effectiveness are unknown. Mark Hirsch, a medical team leader in CDER’s Division of Reproductive and Urologic Products, says on the FDA’s website that “taking sildenafil in addition to certain prescription drugs containing nitrates may lower blood pressure to an unsafe level.”

Following its analysis of the tablets, the FDA had initiated an inspection April 22 at SEI and informed the company of the product’s potential adverse health risks. Florida state officials then issued a “stop sale” action May 13 at SEI’s distribution facility to keep the illegal product out of the marketplace, according to the FDA.