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.
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
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