FDA to Revisit ProHeart6 for Dogs

Committee will discuss heartworm preventive that was recalled in 2004 for safety concerns.

Posted: February 1, 2010, 2 a.m. EST

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The next meeting of the U.S. Food and Drug Administration’s Veterinary Medicine Advisory Committee will discuss the current Risk Minimization Act Plan for ProHeart 6. The discussion, which takes place March 24, 2010 at the Rockville Hilton in Rockville, Md., will be based on data gathered during the first 18 months of marketing the heartworm preventive under a RiskMAP.

The goal of this RiskMAP strategy is to manage the re-introduction of ProHeart 6 to ensure safe, appropriate use to achieve the maximum benefits of heartworm protection, while minimizing risk to dogs. Fort Dodge Animal Health voluntarily recalled ProHeart 6 in September 2004 to address the FDA’s Center for Veterinary Medicine’s safety concerns about the product.

CVM will present the results of the FDA’s analysis of 18 months of information collected under the RiskMAP, and also will seek feedback from a panel of experts. The meeting is open to the public and interested persons may present oral or written data, information or views on the issues pending before the committee.

Written statements may be sent to Aleta Sindelar, CVM, (HFV-3), FDA, 7519 Standish Place, Rockville, MD 20855 by March 17. Oral presentations from the public are set from 1 to 2 p.m. on March 24. Interested persons must notify Sindelar by March 9.

Time allotted for each oral report may be limited. Individuals are required to submit a brief statement of the general nature of the evidence or arguments they would like to make, the names and addresses of proposed participants, as well as an indication of an estimated time requested to present their case.

Notifications regarding requests to speak will be made by the contact person March 10. The meeting has been scheduled from 8:30 a.m. to 5 p.m.

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THOMAS   DALLAS, TX

3/13/2010 11:41:09 PM

this is a killer drug PLEASE PLEASE DONT LET IT BACK ON THE MARKET!!!!!! JUST TO KILL OTHER ANIMALS!!!!!!!

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Galadriel   Lothlorien, ME

2/6/2010 11:21:22 PM

Yikes.

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Carol   Port St Lucie, FL

2/3/2010 1:00:46 PM

The practice I am manager of used proheart almost exclusively when it came out the first time with no adverse reactions at all. Seemed strange to get the packet from novartis stating proheart being pulled before the company even let us know. Would be #1 heartworm prevention in this hospital now if it wasn't for the restrictions.

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Dr. Dave   Longmont, CO

2/3/2010 10:03:05 AM

Proheart will kill dogs, and I have seen that happen in practice. Don't kid yourselves about this. The reason it might be used again is that some argue that it saves more lives than it kills since so many people forget to give the monthly pills.

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