Unspecified problems with manufacturing pentobarbital sodium in combination with phenytoin sodium have caused sales limits and backorders on some veterinary euthanasia drugs.
Veterinarians in late September began noticing the shortage and discussing it on a message board of the Veterinary Information Network, an online community for the profession. Some reported being able to obtain only a week's supply at a time.
“We have been told on BO [backorder] till November ... ” wrote Dr. Randy Davis, a veterinarian in Indiana. “We have used Beuthanasia and Euthasol in past but told both on BO!!”
Michael Albo, a spokesman for Virbac, which markets Euthasol, told the VIN News Service this week that two issues caused the short supply: “The contract manufacturing organization was implementing corrective actions in the manufacturing process, and concurrently, the manufacturer of the active pharmaceutical ingredient experienced slippage in their own production,” he said.
However, Albo added, "We are back on target and product is available on a monthly basis.”
Merck, marketer of Beuthanasia-D, did not respond to a request for information.
Other sources indicated the situation had not yet eased. The U.S. Food and Drug Administration posted on Tuesday a shortage of “pentobarbital sodium + phenytoin sodium” at "various companies" due to a "manufacturing delay."
FDA spokeswoman Lindsay Dashefsky said that the agency on Tuesday also classified the affected drugs as a "medically necessary veterinary product," or MNVP.
Dashefsky explained by email: "If a product is considered to be a MNVP, the agency will consider special actions to alleviate the shortage. Some examples of actions may include working with industry to resolve issues leading to the product shortage; and encouraging manufacturers of similar or alternative products to increase their production or prioritizing review of pending applications for products that could alleviate the shortage."
Meanwhile, Davis, the practitioner in Indiana, has been scrambling for substitutes. He said he was able to get a bottle of SomnaSol, another drug containing the combination of pentobarbital sodium and phenytoin sodium, that had been on backorder but was released recently. He also was able to get a bottle of Fatal-Plus, which has only pentobarbital sodium as the active ingredient.
Blair Harding of Vortech Pharmaceuticals, developer of Fatal-Plus, said pentobarbital itself has not been subject to a manufacturing shortage. "We have plenty of raw material and finished product. Distributors should have it," he said.
Fatal-Plus is a schedule II drug, a more restrictive classification for controlled substances than that of the pentobarbital/phenytoin drugs. As such, to obtain it, practitioners must submit a U.S. Drug Enforcement Administration Form 222.