Dr. Stephen Sundlof, director of FDA's Center for Veterinary Medicine
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ROCKVILLE, MD.—Fort Dodge Animal Health vows to work with the Food and Drug Administration (FDA) to get its voluntarily recalled heartworm
preventive back on the market.
An independent review panel on Proheart 6 was split (8-7) when asked to make a decision on questions of safety for the profession's
only injectable heartworm medication.
The 15-member panel, organized through FDA's Veterinary Medical Advisory Committee (VMAC), was charged with making a recommendation
to FDA on the safety of Proheart 6. The medication was recalled voluntarily late last year due to an increase in adverse reaction
reporting. Fort Dodge stands behind the safety of its product.
Says the agency will review new data from Purdue's Dr. Lawrence T. Glickman, on the safety of Proheart 6.
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Dr. Lawrence Glickman, VMD, DrPH, FACE, professor of epidemiology and public health and head of the clinical epidemiology
section of Purdue University's School of Veterinary Medicine, presented data reviewing almost 7 million canine visits at more
than 400 Banfield hospitals.
Glickman's data showed a safety profile similar to two other heartworm preventives on the market.
More than half of VMAC members called for further research to more clearly define the reasons behind serious adverse events
leading up to the voluntary recall. Other panel members said the compliance benefits outweighed reported adverse event risks.
Some key findings from Glickman's study include:
- In the analysis, Banfield had administered more than 700,000 doses of ProHeart 6 and a like amount of doses of oral heartworm
preventive medications.
- No clinically significant increase was attributed to ProHeart 6 use in the risk of liver-related adverse events, neurological
disease, ocular disease, immune-mediated disease, cardiovascular disease, anaphylaxis, inflammatory bowel disease, or death,
when compared with two commonly used monthly oral heartworm preventives.
- While ProHeart 6 was associated with an increased rate of some liver-related adverse reactions in the univariate analysis,
this increased rate was not found in either the days at risk, or in the multivariate analysis. However, all the heartworm preventives and vaccines were associated with a clinically significant increased risk of allergic reactions
in the univariate and multivariate analyses, Banfield reports.
- Mast-cell tumor was the only potential adverse event studied that was independently associated with an increased risk following
ProHeart 6 use. However, the absolute magnitude of the risk of mast-cell tumor associated with ProHeart 6 alone, or ProHeart
6 plus a vaccine, was small, (1.2 and 1.9 per 10,000 doses, respectively). Compared with the rate of mast-cell tumor in dogs
receiving a vaccine alone, the rate associated with dogs receiving ProHeart 6 plus a vaccine does not appear to be clinically
significant, the research says.
VMAC members were asked to answer two key scientific questions:
- "Based on presentations and information provided is Proheart 6 safe for use in dogs?"
- "If there are remaining safety concerns with Proheart 6, what additional avenues of research could be explored to mitigate
and/or prevent adverse events?"
Dr. Rami Cobb, vice president of pharmaceutical research and development for Fort Dodge Animal Health reports "Fort Dodge
Animal Health will continue to work closely with the CVM to resolve any remaining concerns with the product. We feel strongly
the thorough testing, comprehensive analysis of the related data and findings of independent scientific experts have demonstrated
ProHeart 6 is safe and effective."
Dr. Will Novak, chief medical officer with Banfield, says, "Based on Dr. Glickman's analysis of scientific data from more
than 7 million canine visits at approximately 400 Banfield full-service hospitals, we believe ProHeart 6 is an extremely safe
and effective product in preventing heartworm."
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