Fort Dodge Animal Health of Overland Park, Kan., will voluntarily comply with the U.S. Food and Drug Administration Center for Veterinary Medicine’s request to temporarily cease production and recall ProHeart 6 from the market until the FDA’s questions regarding safety are resolved.
The FDA is advising veterinarians to avoid administering this product to dogs until further notice.
The FDA is also convening an independent scientific advisory committee to evaluate available data, a move Fort Dodge is supporting.
“While Fort Dodge Animal Health is cooperating with FDA’s request for a recall, we have concerns about how the agency interpreted these complex data,” the company said via a formal statement distributed late Friday afternoon. “As such, the company fully supports the initiation of this review process and will work closely with FDA to provide any necessary information for the panel to make a fair and accurate assessment of these data. We look forward to working with the panel and remain confident in the safety and efficacy of ProHeart 6.”
Fort Dodge reported that the data indicates that the incidence of disease and death seen with the use of ProHeart 6 is at or below what would be expected for the U.S. dog population.
Specifically, Fort Dodge said the overall incidence of adverse events represent less than one half of one percent of more than 18 million doses that had been sold to veterinarians; for hemoatologic and autoimmune signs, the incidence rate is one in 31,000 doses, which the company said was below the baseline incidence for dogs; and that the average age for liver sighs in ProHeart 6 reports is within the range reported in the general canine population.
Fort Dodge also noted that adverse event reports include cases that are subsequently determined not to be related to the product in question. The FDA, conversely, estimates the number of adverse events is greater than the number of reports because “studies show that only a fraction of actual ADEs are reported.”
As of August 4, the CVM had received 5,552 adverse event reports for ProHeart 6, which was approved in June 2001. The FDA reported it had “observed an increase in the number of cases associated with liver and bleeding abnormalities followed in some cases by death.”
The FDA has requested that Fort Dodge continue to research the cause of related adverse reactions and develop a strategy to prevent future problems before the product is marketed again.
Previously, Fort Dodge had agreed to change the label to include post approval safety information, including rare reports of death and a caution that dogs should test negative for heartworm before receiving the product.