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Producer responds to FDA recall of ProHeart 6
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Fort Dodge Animal, the producer of the milbemycin containing Proheart® 6, says it will voluntarily comply with the recent FDA’s request to recall Proheart® 6, the only injectable heartworm preventive on the market. Currently, the reasons for many of the sometimes fatal side effects of the product remain unclear.
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The Food and Drug Administration (FDA) will create an independent advisory panel to further investigate the numbers of adverse reactions associated with the product before the product can be marketed again.
The company says it has “concerns about how the agency interpreted these complex data.” The company adds in a prepared statement that it “fully supports the initiation of this review process, and will work closely with FDA to provide any necessary information for the panel to make a fair and accurate assessment of these data.” Fort Dodge stands behind the safety of its product.
Dr. Stephen Sundlof, director of FDA’s Center for Veterinary Medicine, says, “This was the first product administered once every six months, which has some good advantages for compliance. We are started seeing some adverse reactions that we did not see in the preclinical studies.”
“We don’t understand why this drug is causing some of these problems,” Sundlof says. `Until we can understand that better and develop ways to reduce adverse events, we thought it is important to not expose any more dogs to this product.”
Source: DVM Newsmagazine Sep 8, 2004; www.dvmnewsmagazine.com/dvm/
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