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Reintroduction of the recalled heartworm preventive Proheart 6?
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Some months ago, the producer of the moxidectin-containing Proheart 6, Fort Dodge Animal Health, recalled the drug voluntarily due to an increase in adverse-reaction reporting. Now the company vows to work with the FDA to get it back on the market. The Veterinary Medicine Advisory Committee is split...
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An independent review panel on Proheart 6 was split down the middle when asked to make a decision on questions of safety for the industry`s only injectable heartworm medication.
The 15-member panel, organized through the FDA`s Veterinary Medicine Advisory Committee (VMAC), was charged with making a recommendation to FDA on the fate of Proheart 6.
Dr. Lawrence Glickman, 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.
These data showed a safety profile similar to two other heartworm preventives on the market. He recommended its reintroduction to the market.
About half of committee members cited a need for further research to more clearly understand the seeming disparity between serious adverse drug events attributed to moxidectin before its recall and the most recent survey. The other half of VMAC`s committee was satisfied with the safety data presented.
FDA plans to review the new information before a final decision is made on the fate of the product. No timeline for a decision was set.
Source: www.dvmnewsmagazine.com/dvm/
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