ProHeart6 Recalled
Posted: Wed Dec 15, 2004 10:33 pm
Home » ProHeart6 Recalled
| Advanced Search
VP Client Information Sheets
By VIN Community Contributors
ProHeart6 Recalled
Authored by: Phyllis DeGioia, Editor
(This article was compiled from information issued by FDA and Fort Dodge.)
For more information:
Fort Dodge Animal Health
FDA
At the FDA's request in early September, 2004, Fort Dodge Animal Health voluntarily ceased production and recalled its heartworm medication ProHeart®6 until the FDA's concerns about adverse reaction reports associated with it are resolved. The FDA requested that Fort Dodge continue to conduct research to determine if the cause of adverse reactions is related to ProHeart6 and to develop a strategy to help prevent such problems before the product is marketed again. The FDA is convening an independent scientific advisory committee to evaluate available data.
ProHeart6 is an approved injectable sustained-release heartworm prevention product for dogs. Heartworm disease is a serious and potentially fatal condition of dogs, cats, and other species of mammals. The parasite that causes heartworm disease is transmitted through the bite of a mosquito.
The FDA has observed an increase in the number of adverse event reports associated with liver and bleeding abnormalities.
FDA advises veterinarians to avoid administering this product to dogs until further notice. Pet owners should consult their veterinarians regarding their pet's health care.
Since the product was approved in June 2001, Fort Dodge Animal Health has cooperated with FDA to investigate adverse event reports. As a result, Fort Dodge voluntarily changed the label to include post approval safety information including rare reports of death and a caution to practitioners that dogs should have a negative test for heartworm before administration.
Despite these label changes, FDA is still receiving unexplained adverse event reports, some of them severe. FDA's concern is based on voluntary self-reporting to FDA by veterinarians and owners whose dogs have had adverse experiences to ProHeart6, which contains the drug moxidectin, as well as the mandatory reporting of adverse events by Fort Dodge Animal Health.
As of August 4, 2004, FDA's Center for Veterinary Medicine had received 5,552 adverse event reports for ProHeart6.
While Fort Dodge Animal Health is cooperating with FDA’s request for a recall, the company has concerns about how the FDA interpreted the complex data. As such, Fort Dodge supports the review process, and has indicated it will work closely with FDA to provide any necessary information for the panel. Spokespeople for Fort Dodge say the company remains confident in the safety and efficacy of ProHeart6 based on an evaluation of FDA’s data and consultation with independent experts in veterinary medicine and epidemiology.
Fort Dodge wants to point out to consumers that potential adverse events reported to the FDA are “unfiltered,” meaning all reported potential events are submitted without regard to cause, and cases subsequently determined not to be related to the product are still included in the overall reporting numbers. Fort Dodge says an evaluation of the data indicates that the incidence of disease and death seen with the use of ProHeart 6 is at or below the baseline (the normal number that would be expected) for the U.S. canine population. Specifically:
The overall incidence of adverse events represent less than one half of one percent of the more than 18 million doses have been sold to veterinarians.
For hematologic and autoimmune signs, the incidence rate is one in 31,000 doses, well below the baseline for the U.S. canine population.
The average age for liver signs in ProHeart6 reports is within the range reported in the general canine population.
Date Published: 9/4/2004 11:29:00 AM
| Advanced Search
VP Client Information Sheets
By VIN Community Contributors
ProHeart6 Recalled
Authored by: Phyllis DeGioia, Editor
(This article was compiled from information issued by FDA and Fort Dodge.)
For more information:
Fort Dodge Animal Health
FDA
At the FDA's request in early September, 2004, Fort Dodge Animal Health voluntarily ceased production and recalled its heartworm medication ProHeart®6 until the FDA's concerns about adverse reaction reports associated with it are resolved. The FDA requested that Fort Dodge continue to conduct research to determine if the cause of adverse reactions is related to ProHeart6 and to develop a strategy to help prevent such problems before the product is marketed again. The FDA is convening an independent scientific advisory committee to evaluate available data.
ProHeart6 is an approved injectable sustained-release heartworm prevention product for dogs. Heartworm disease is a serious and potentially fatal condition of dogs, cats, and other species of mammals. The parasite that causes heartworm disease is transmitted through the bite of a mosquito.
The FDA has observed an increase in the number of adverse event reports associated with liver and bleeding abnormalities.
FDA advises veterinarians to avoid administering this product to dogs until further notice. Pet owners should consult their veterinarians regarding their pet's health care.
Since the product was approved in June 2001, Fort Dodge Animal Health has cooperated with FDA to investigate adverse event reports. As a result, Fort Dodge voluntarily changed the label to include post approval safety information including rare reports of death and a caution to practitioners that dogs should have a negative test for heartworm before administration.
Despite these label changes, FDA is still receiving unexplained adverse event reports, some of them severe. FDA's concern is based on voluntary self-reporting to FDA by veterinarians and owners whose dogs have had adverse experiences to ProHeart6, which contains the drug moxidectin, as well as the mandatory reporting of adverse events by Fort Dodge Animal Health.
As of August 4, 2004, FDA's Center for Veterinary Medicine had received 5,552 adverse event reports for ProHeart6.
While Fort Dodge Animal Health is cooperating with FDA’s request for a recall, the company has concerns about how the FDA interpreted the complex data. As such, Fort Dodge supports the review process, and has indicated it will work closely with FDA to provide any necessary information for the panel. Spokespeople for Fort Dodge say the company remains confident in the safety and efficacy of ProHeart6 based on an evaluation of FDA’s data and consultation with independent experts in veterinary medicine and epidemiology.
Fort Dodge wants to point out to consumers that potential adverse events reported to the FDA are “unfiltered,” meaning all reported potential events are submitted without regard to cause, and cases subsequently determined not to be related to the product are still included in the overall reporting numbers. Fort Dodge says an evaluation of the data indicates that the incidence of disease and death seen with the use of ProHeart 6 is at or below the baseline (the normal number that would be expected) for the U.S. canine population. Specifically:
The overall incidence of adverse events represent less than one half of one percent of the more than 18 million doses have been sold to veterinarians.
For hematologic and autoimmune signs, the incidence rate is one in 31,000 doses, well below the baseline for the U.S. canine population.
The average age for liver signs in ProHeart6 reports is within the range reported in the general canine population.
Date Published: 9/4/2004 11:29:00 AM