Warning: ProHeart6 is back on the market

http://money.cnn.com/news/newsfeeds/art ... RTUNE5.htm

WASHINGTON -(Dow Jones)- The U.S. Food and Drug Administration on Thursday said it will allow a reformulated version of a Wyeth (WYE) heartworm drug for dogs back into the U.S., sparking a powerful U.S. senator to question the agency's decision.

Wyeth unit Fort Dodge Animal Health pulled the drug from the market in 2004 amid reports that 500 dogs died while taking it. The FDA's handling of the situation sparked congressional inquiry after an FDA safety officer said the agency tried to silence her when she raised concerns about the drug.

Sen. Chuck Grassley, R-Iowa, fired off a letter to FDA Commissioner Andrew von Eschenbach on Thursday expressing concerns about how the agency came to its decision to allow the drug, called ProHeart 6, back in the U.S.

Grassley, ranking member on the Senate Finance Committee, said the agency has had 18 meetings and 85 phone calls about ProHeart 6 since it was withdrawn, but doesn't know if any of the meetings involved FDA safety officials.

"I have also learned that FDA may be relying on safety studies for ProHeart 6 that were performed with guinea pigs," Grassley said, according to a statement Thursday.

Grassley said he wants a response from the FDA by June 19 about whether any safety officials were involved in the meetings, and if any of the studies involved dogs.

When asked about whether the company's tests involved dogs or guinea pigs, Wyeth spokesman Doug Petkus said the company conducted all the safety tests in compliance with the FDA's specifications. He added, "You have to remember this [ drug] has extensive field experience with millions of dogs and has been proven as a safe and effective product to treat heartworm around the world."

Heartworm is a parasite that affects millions of dogs, and Fort Dodge officials said in a conference call Thursday that many veterinarians called the company asking them to get the product back in the U.S.

Rami Cobb, a senior vice president at Fort Dodge, said extensive testing and international use of the reformulated drug makes the company "confident" the drug is safe for dogs in the U.S.

The FDA, however, is restricting distribution of the drug and required revised labeling to include more safety information. The FDA said the new label warns people not to give the drug to dogs within a month of receiving a vaccination.

"While we concur with the limited return of ProHeart 6 to the U.S. market, we strongly encourage veterinarians and pet owners to report any possible adverse reactions," said Bernadette Dunha, director of the FDA's Center for Veterinary Medicine, in a statement.

ProHeart 6 was the first product approved by the FDA to be administered every six months. Most other drugs need to be given monthly, and Cobb said test show the new drug results in about one adverse event for every 10,000 dogs that take it.

Prior to the new formulation, studies showed two to three adverse events for every 10,000 dogs that used it, Cobb said.

Adverse events associated with the original form of the drug included seizures, difficulty walking, jaundice (a yellowish appearance), bleeding disorders, convulsions and death.

The new form is free of certain residues that caused the majority of the allergic reactions in dogs.

Company officials couldn't comment on how much the drug would cost or how much they expected to make from it.

Vets who want to use ProHeart 6 will have to register with the company and participate in a Web-based training program. The drug is already marketed in Europe, Japan and Australia. Cobb said ProHeart 6 has a 42% market share in Italy.

The FDA said few adverse events have been reported with the new drug, but urged anyone who suspects his or her dog is experiencing an adverse reaction to immediately contact a veterinarian and call Fort Dodge at 1-800-533-8536.

-By Jared A. Favole, Dow Jones Newswires; 202-862-9207; jared.favole@ dowjones.com

[MaxandMe]

thanks Linda.......you're always one to keep up with the latest news and post it for us

[OLIVER DOODLE]

Thanks Linda. Being a reasonale new dog owner, I did not know of this. Thanks for the heads up. I wonder if this is in Canada?

[lindamarie]

Thanks Linda. We never used that, but having just changed vets, ya just never know what they might prescribe!