BAD HEARTWORM DRUG RETURNS

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WARNING - This heart worm preventative killed many dogs 4 years ago. I do not endorse it use for my puppy buyers!
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By JENNIFER MANN - The Kansas City Star (6-5-08)

After a four-year absence, the Food and Drug Administration is allowing the limited return of the reformulated ProHeart 6 heartworm preventative treatment from Overland Park-based Fort Dodge Animal Health.

Fort Dodge voluntarily withdrew the sustained-release preventative treatment in 2004 after FDA findings of serious adverse reactions in 5,552 dogs following the use of the treatment, and in some instances the death of dogs.

On Thursday, Sen. Charles Grassley, the ranking member of the Senate Finance Committee, which has oversight of the FDA, asked the agency to explain how it determined that ProHeart 6 was safe to return to the market.

Specifically, Grassley said he had learned that the FDA may be relying on safety studies for ProHeart 6 that were performed on guinea pigs. Grassley also asked for details on a series of meetings and telephone calls the FDA held regarding the product.

The FDA did not return calls from The Star.

Fort Dodge Animal Health spokeswoman Kelly Goss said the company has fully cooperated with Grassley in his investigation and has strictly followed all regulatory requirements.

“We have complied with all of the FDA’s testing requirements. Everything that has been requested of us has been undertaken and completed,” Goss said. “Specifications are set out, and we follow those very stringently, and we are always fully compliant.”

Rami Cobb, senior vice president of pharmaceutical research and development for Fort Dodge Animal Health, said Thursday that the company was pleased it could again make the preventative treatment available to pet owners.

“Our first and foremost priority is to continue to be providing products that help ensure the health and well-being of all animals,” Cobb said.

Most treatments to prevent heartworm in dogs, a sometimes fatal condition, are given in monthly oral dosage, whereas the ProHeart 6 is an injection given by vets that lasts six months. The American Heartworm Society estimates that as many as 27 million dogs in the U.S. are not currently on a preventative treatment.

The drug was withdrawn after a pattern of adverse reactions in pets. Upon further testing, the company said it believed that residue of solvents used in the manufacture of the product was causing the allergic reactions. Fort Dodge Animal Health said that after it improved manufacturing specifications, the incidence of reactions showed a marked decrease.

Cobb noted the product has been in continuous use in some markets outside the U.S. and has a 51 percent market share in Australia and a 42 percent share in Italy.

She said she didn’t know how much demand there would be for ProHeart 6, which will fall under the FDA’s new risk minimization and restricted distribution program to manage the controlled reintroduction of the product. Under the program, Fort Dodge Animal Health will require vets to register with the company and participate in a training program.

“I do know that over the years many vets have contacted us to bring it back because they think there is a very real need for it,” Cobb said.

News of reintroduction of ProHeart also reignited an issue regarding allegations that Fort Dodge and its parent company, Wyeth Pharmaceuticals, conducted a campaign to discredit Victoria Hampshire, the FDA official who first raised questions about the safety of ProHeart.

In his letter to the FDA Thursday, Grassley said he was still waiting for a response to a number of questions he previously asked pertaining to Hampshire, answers that he said are more than four months past due.