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CVM Update http://www.fda.gov/cvm/ProHeart6Update_0608.htm

June 5, 2008

CVM announces the Return of Fort Dodge Animal Health’s ProHeart® 6

Today the U.S. Food and Drug Administration Center for Veterinary Medicine (CVM) is announcing the return of Fort Dodge Animal Health’s ProHeart® 6 (moxidectin) Sustained Release Injectable for Dogs, NADA 141-189, under a strengthened risk minimization and restricted distribution program. The program is designed to enhance the safe use of the heartworm preventive while continually evaluating the product safety.

Since the drug was recalled in September, 2004, the manufacturers (Fort Dodge Animal Health) have conducted studies to further evaluate the safety profile of ProHeart® 6 and to investigate the reported adverse events. These studies included additional toxicologic and pharmacologic evaluations which suggested the potential allergenic nature of some of the residual solvents that are utilized in the manufacture of ProHeart® 6. As a result, Fort Dodge has changed the manufacturing specifications for ProHeart® 6 and has marketed the modified product in international markets. In the years following this change, there has been a decline in the adverse event reporting in international markets. The results of the toxicologic studies coupled with the lower adverse event frequency in international markets were factors in FDA’s decision to concur with Fort Dodge’s restricted return of ProHeart® 6 to the U.S. market under a risk minimization plan. In addition to the plan, based on post-approval experience, the ProHeart® 6 label and Client Information Sheet have been revised to include updated safety information. label and Client Information Sheet.

Fort Dodge is implementing an educational and communication program that will require veterinarians to register with Fort Dodge and complete in-depth training as a condition of purchasing ProHeart 6. Fort Dodge will require veterinarians to confirm they have completed the in-depth training, read the new label, the conditions of use, the requirements to provide the dog owner with the Client Information Sheet and obtain signed informed consent, record the product lot number in the medical record, and report adverse events. Veterinarians are also advised to obtain baseline history, physical exam, and blood-work parameters prior to administration of the drug to confirm the patient is an appropriate candidate for ProHeart 6.

The program allows veterinarians to weigh the risk of heartworm disease in their patients with the benefits of using the drug, thus maximizing the benefits of heartworm protection, while minimizing the risk to dogs.

ProHeart 6 RiskMAP May 2008
Frequently Asked Questions on the ProHeart 6 Risk Minimization and Restricted Distribution Program June 5, 2008
Fort Dodge Dear Doctor Letter June 5, 2008
CVM Letter to American Veterinary Medical Association (AVMA) June 5, 2008
CVM Letter to American Animal Hospital Association (AAHA) June 5, 2008
CVM Letter to American Heartworm Society (AHS) June 5, 2008
CVM letter to Veterinarians June 5, 2008
Federal Register Notice June 9, 2008

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Issued by:
FDA, Center for Veterinary Medicine,
Communications Staff, HFV-12
7519 Standish Place, Rockville, MD 20855
Telephone: (240) 276-9300 FAX: (240) 276-9115
Internet Web Site: http://www.fda.gov/cvm

Web page updated by hd - June 18, 2008, 11:22 AM ET
 

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Fort Dodge is implementing an educational and communication program that will require veterinarians to register with Fort Dodge and complete in-depth training as a condition of purchasing ProHeart 6. Fort Dodge will require veterinarians to confirm they have completed the in-depth training, read the new label, the conditions of use, the requirements to provide the dog owner with the Client Information Sheet and obtain signed informed consent, record the product lot number in the medical record, and report adverse events.

Sounds good in practice, but the reality will look quite different.

Pfizer has similar expectations from vets, a la warning their clients before the use of Rimadyl ("death" can be a side effect) and providing them with a client info sheet and informed consent, yet most people are never told of any side effects let alone get any piece of paper from their vet, or prior recommended bloodwork done, before the product is handed out. Betcha, it's gonna be just the same with Proheart6.
 
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