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ProHeart 6 Heart Worm Medication Recalled
ProHeart 6 Heart Worm Medication Recalled
Fort Dodge Animal Health agrees to comply with U.S. Food
and Drug Administration to cease production.
September 5, 2004
Fort Dodge Animal Health, of Overland Park, Kansas, at FDA's
request, has agreed to immediately cease production and recall
its heartworm medication ProHeart 6 from the market until
the FDA's concerns about adverse reaction reports associated
with the product can be resolved. The FDA is requesting that
the firm continue to conduct research to determine the cause
of related adverse reactions and develop a strategy to help
prevent such problems in the future before the product is
marketed again. The FDA will convene an independent scientific
advisory committee to thoroughly evaluate all available data.
ProHeart 6 is an approved injectable sustained-release heartworm
prevention product for dogs. Many veterinarians prefer ProHeart
6 because the medication is injected, ensuring that it is
completely absorbed into the blood stream.
The FDA is also advising veterinarians to avoid administering
this product to dogs until further notice. Pet owners should
consult their veterinarians regarding their pet's health care
needs.
Since the product was approved in June 2001, Fort Dodge Animal
Health has cooperated with FDA to investigate numerous adverse
event reports. As a result, Fort Dodge has 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 suffered adverse drug experiences
(ADEs) to ProHeart 6 (which contains the drug moxidectin)
as well as the mandatory reporting of adverse events by Fort
Dodge Animal Health.
Fort Dodge Animal Health has agreed to recall any product
that has already been distributed to veterinarians.
As of August 4, 2004, FDA's Center for Veterinary Medicine
(CVM) had received 5,552 adverse event reports for ProHeart
6. The actual number of adverse events is likely even higher
because studies show that only a fraction of actual ADEs are
reported.
The Center has observed an increase in the number of cases
associated with liver and bleeding abnormalities followed
in some cases by death.
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