FDA will allow Merial to import limited amounts of European version of Immiticide

FDA will allow Merial to import limited amounts of European version of Immiticide

Veterinarians asked to be conservative in treating dogs with the drug
Sep 30, 2011
By dvm360.com staff
Rockville, Md. -- The U.S. Food and Drug Administration (FDA) announced today that it would allow Merial to import limited quantities of Immiticide from a European supplier to address concerns over a shortage of the drug to treat heartworm infection in dogs.

FDA says the arrangement for U.S. veterinarians is temporary while Merial works out technical issues in the plant where Immiticide is manufactured for this market. Merial’s European supplier is an approved source of the product for international markets, but only has a limited supply for importation into the United States. The amount of product entering the country sometime this month will only satisfy a fraction of the U.S. demand, FDA notes. Therefore, the agency is asking veterinarians to be conservative in their use of the drug.

The imported Immiticide will only be available through a restricted distribution program directly from Merial. The drug will not be available through any of the manufacturer's distributors or for purchase to stock clinic inventory, FDA says. The agency notes that the packaging of the imported product is intended for the European market and does not meet U.S. regulatory requirements, so Merial will include the U.S. Immiticide package insert with each shipment.

Shortly after Merial announced the impending shortage of Immiticide, orders from veterinarians flooded in and wiped out the company’s supply of the drug, Merial says. The resulting shortage could last for weeks or months, the company adds. Until supplies of the heartworm treatment stabilize, Merial says it has recorded requests from veterinarians and will contact those veterinarians when supplies become available.

Additional questions can be directed to Merial at (888) 637-4251.

As previously reported by DVM Newsmagazine, the American Heartworm Society crafted a set of guidelines to help veterinarians with the treatment of heartworm positive dogs.

In fact, the AHS recommendations include:

· Reduce potential pathology from infection

· Maintain the health of the heartworm-positive dog until it can be appropriately treated

· Prevent additional heartworm infection of the dog.

Management steps include:

· Verification of heartworm status

· Pretreatment of heartworm-positive dogs to prevent shock

· Careful administration of a macrocyclic lactone heartworm preventive, followed by clinical observation for at least eight hours

· Continuous administration of a heartworm preventive on the regular dosing schedule

· Administration of doxycycline on a one-month-on/two-months-off schedule

· Restricted activity and exercise of the heartworm-positive dog throughout the management period · Medical treatment of symptomatic heartworm infection to relieve signs of respiratory disease, with surgical options weighed for dogs exhibiting cardiovascular compromise

· Retesting for heartworm status before treatment with adulticide treatment once the product is again available.