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on the Senate Finance Committee, said the agency has had 18 meetings and 85 phone calls about ProHeart 6 since it was withdrawn, but doesn’t know if any of the meetings involved FDA safety officials.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.
“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 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.
A personal note–please, do give your doggie heartworm medication. Years ago, my sweet doggie (may she rest in peace) got heartworms. Believe me, the treatment is horrible for the poor puppy, and it is very expensive for the owner. All it takes for a pup to get heartworms is one mosquito bite.