CLEVELAND, Ohio -- For years, dog owners and veterinarians have been faced with a shortage of the only FDA-approved medication to treat heartworm in dogs — a shortage, it turns out, connected to a Northeast Ohio drug manufacturer. On Tuesday, the FDA approved continuing to import the drug from Europe — just weeks away from the shutdown of Bedford-based Ben Venue Laboratories Inc., the sole U.S. supplier of the drug, Immiticide.
Ben Venue had been making Immiticide (the brand name of melarsomine dihydrochloride) for Duluth-based Merial, the animal health arm of Sanofi, according to labeling information for the drug. Merial is now working with the FDA to import some of the drug from Europe until another U.S. supplier is approved, according to the company.
Immiticide, which quickly kills adult heartworms in dogs, is the only FDA-approved treatment for the disease. Heartworm is a potentially deadly infection with a parasite that lives in the arteries of the lungs and sometimes in the right side of the heart of dogs, but can also be found in cats, wolves, foxes and ferrets, according to the American Heartworm Society.
Pet owners commonly give their dogs a preventive treatment, prescribed by veterinarians. That medication is different from Immiticide, which is given only after an infection.
While the disease is not a huge problem in Northeast Ohio, it is becoming increasingly common in the Cuyahoga River Valley because of foxes and coyotes in the Cuyahoga Valley National Park, who pass the infection to dogs through mosquitoes, said Dave Koncal, a veterinarian at Northfield Veterinary Clinic in Northfield and president-elect of the Ohio Veterinary Medical Association.
"It's a heartworm area, and it's getting worse because of the varmints down there," he said. Koncal, who treated a dog for heartworm with the drug about six months ago, said the FDA's measures have eased the major shortage problems of two years ago. Koncal confirmed Ben Venue as the supplier and noted the oddity of importing a drug from France when the U.S. supplier is "right around the corner" from his practice.
Ben Venue did not return calls seeking comment.
Supplies of the drug have been shaky since 2009, when issues arose in securing the product’s active ingredient, which is arsenic-based, and federal regulations made it difficult for Merial to import the ingredient from its European supplier.
In August of 2011, Merial informed veterinarians that it was nearing the end of its supply of the drug, and a subsequent run on the remaining stock during the following week eliminated what was left. In response, the FDA approved a temporary measure to import Immiticide from Merial’s European supplier.
On Tuesday, the FDA's Center for Veterinary Medicine announced it would continue the limited imports. Since 2011, the drug has been available on a case-by-case basis, “only for dogs in most urgent need of treatment,” according to a letter Merial sent to veterinarians in early November.
Ben Venue’s production shutdown comes on the heels of several years of supply and quality problems, and is the result of an aging facility and inability to invest the necessary funds to maintain standards, according to a company release.
The company voluntarily shut down manufacturing in November 2011 after inspections by the U.S. Food and Drug Administration showed numerous deviations from good manufacturing and quality control. In January 2013, the company entered into a consent decree with the FDA, allowing it to manufacture critical cancer drugs the federal agency said were in short supply.
The company, owned by German drugmaker Boehringer Ingelheim Corp., notified more than 500 of its 1,100 employees that they will be laid off Dec. 27.The company also has said it will be working with public officials to try to find a buyer for the plant.
Koncal, of the Northfield vet clinic, said he's optimistic about Merial sorting out its domestic supply of Immiticide, and while veterinary practices have no ready supply of the drug, it's been easy enough lately to get it from the company when needed.
He advised pet owners to remain consistent in giving dogs preventive medications.
"People who are getting complacent and aren't treating their pets anymore are exposing them to disease," he said.
http://www.cleveland.com/healthfit/index.ssf/2013/12/heartworm_drug_shortage_for_do.html
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