The FDA has announced an upcoming Veterinary Medicine Advisory Committee (VMAC) meeting to discuss ProHeart 6. The meeting will be open to the public and will be held on March 24th, 2010 from 8:30 a.m. to 5:00 p.m. at the Rockville Hilton in Rockville Maryland.

ProHeart 6 was released in June 2001 by Fort Dodge Animal Health as an innovative preventative for canine heartworm disease for six month and treat existing larval and adult canine hookworms. The active ingredient in ProHeat 6 is Moxidectin, a macrocyclic lactone, which had been thoroughly evaluated in multiple animal species and is approved for use in cattle, swine, sheep, dogs and horses in 70 countries.

Unlike other heartworm preventatives in dogs, ProHeart 6 was the first to be administered as a subcutaneous injection which provided a sustained-release of Moxidectin for six months of heartworm protection. ProHeart 6 was specifically developed to overcome poor compliance of monthly treatments and provide an avenue of continuous protection against heartworm infection.

Shortly after the initial launch, Fort Dodge receive several reports of allergic-type reactions. Reactions ranged from mild to severe and even many deaths. Efforts were made to reduced the number of adverse events, but after continued FDA concerns Fort Dodge voluntarily removed the product from the market in September 2004. The recall prompted regulatory authorities in Canada, Australia, Japan, and Europe to further review the safety of ProHeart 6, but these authorities have allowed continued marketing of the product in those countries. In late 2004 ProHeart SR 12 was the market leader in Australia with a 47% market share.

Further studies have been conducted in the U.S. by Fort Dodge since including additional toxicologic and pharmacologic evaluations which suggest the potential allergenic nature of some ProHeart 6 residual solvents. Fort Dodge made changes in the manufacturing process and there has since been a decline in adverse events in the International market. The FDA even created an independent Advisory Panel to review safety data on ProHeart 6.

In June 2008 the results of the additional toxicologic studies coupled with the low adverse event frequency in International markets lead to a restricted return of ProHeart 6 to the U.S. market. In addition Fort Dodge put into place a Risk Minimization Action Plan (RiskMAP) for the first 12 months of the products return. The RiskMap objectives were to provide comprehensive veterinary training, consent forms and information to owners, and to provide quarterly reports to the CVM (Center of Veterinary Medicine). Any adverse events would be reported and discussed with the CVM monthly.

The FDA’s Veterinary Medical Advisory Committee will now meet in March to discuss the current RiskMap for ProHeart 6 based on data generated in the first 18 months of marketing under the RiskMAP. The CVM will be presenting the results of their analysis of 18 months of data generated under the RiskMAP and are seeking feedback from their expert panel.

The meeting is open to the public and interested persons may present data, information, or views, orally or in writing, on the issues pending before the committee. Written submissions may be made to Aleta Sindelar, CVM (HFV-3), FDA, 7519 Standish Place, Rockville, MD 20855 on or before March 17, 2010.

Oral presentations from the public will be scheduled between approximately 1:00 p.m. and 2:00 p.m. on March 24. Interested persons should notify Aleta Sindelar on or before March 9, 2010 and submit a brief statement of the general nature of the evidence or arguments they wish to present, the names and addresses of proposed participants, and an indication of the approximate time requested to make their presentation. Time allotted for each presentation may be limited. The contact person will notify interested persons regarding their request to speak by March 10, 2010.

Additional background information will be made available and posted in advance of the meeting as soon as it becomes available. Up-to-date information on the VMAC meeting is also available on the FDA Advisory Committee Information Line at 1-800-741-8138 or 301-443-0572 (code number 3014512548).

FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with physical disabilities or special needs. If special accommodations are required due to a disability, please contact Aleta Sindelar at least 7 days in advance of the meeting.