November 15, 2004

 

 FDA-CVM posts new information on ProHeart 6 recall - November 15, 2004

Posted on November 1, 2004
 

On Oct. 8, the Food and Drug Administration's Center for Veterinary Medicine posted an updated list of frequently asked questions about the recall of ProHeart 6.

Fort Dodge Animal Health voluntarily recalled the drug on Sept. 3 at the request of the FDA. FDA officials said they recommended that the drug be recalled because they have received more than 5,500 adverse events reports attributed to ProHeart 6, including 600 deaths. The company has said it stands behind the safety of the drug. Fort Dodge and the FDA are looking to a panel of independent scientific experts to review the FDA's decision.

The controversy surrounding the recall was covered in an article in the Oct. 15 issue of JAVMA, and is available online, at www.avma.org/onlnews/JAVMA/oct04/041015a.asp.

The recall has raised questions from dog owners and veterinarians, and the updated FAQ addresses some of these questions. The FAQ details the FDA's methods for evaluating adverse event reports and its reasons for recommending a recall. The FAQ is posted at www.fda.gov/cvm/index/safety/PH6QA.htm.