FERRET-SEARCH@LISTSERV.FERRETMAILINGLIST.ORG
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Date: | Sun, 5 Sep 2004 17:29:09 -0400 |
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I have stated before that I would NEVER use this on any animal let alone
a ferret. The FDA seems to finally acknowledge the deaths and problems
Proheart6 has caused. Considering it is a 6month injection why would
anyone take that chance? At least with the monthly heartworm
preventatives if a reaction is caused you don't have to wait 6 months
or more for it to leave the system. And some of the problems it has
caused are permanent. I don't see the need in most situations that
heartworm preventative is even necessary to use in ferrets. Please
research heartworm and what must transpire for an animal to contract
it before using any preventatives, for any of your animals. Check out
this site for more info:
http://www.bullovedbulldogs.com/heartworm.htm
~Amy~
http://www.fda.gov/bbs/topics/ANSWERS/2004/ANS01312.html
FDA Talk Paper
September 3, 2004
Fort Dodge to Comply with FDA's Request to Recall ProHeart 6 Injectable
Heartworm Product from the Market Due to Serious Health Concerns
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.
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. 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.
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 Agency has observed an increase in the number of cases associated
with liver and bleeding abnormalities followed in some cases by death.
[Posted in FML issue 4627]
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