ella5
southwest USA
Senior Member
Joined: 04/02/2002
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If you haven't come across this yet, here's something to be aware of:
http://www.fda.gov/bbs/topics/ANSWERS/2004/ANS01312.html
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.
ella
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Kim's Caboose
Brazos Valley Texas USA
Senior Member
Joined: 08/12/2002
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Interesting that you posted this. I tried to advise another member a few months ago not to use this since one of my dogs had a bad reaction to this and I had read about others who had died. Thanks for the update...I kinda thought it was coming.
Kim with DOTL Minpins, Spc. Rusty and Spc. Cappi
2005 Ford F250 Lariat, PSD, FX4, Crew Cab, Reese 16K slider
2004 Northwood Arctic Fox 29-5T, twin Honda EU2000i
Some minds are like concrete thoroughly mixed up and permanently set.
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