WHAT'S
NEW
NEWS
RELEASE
For Immediate Release
FORT
DODGE ANIMAL HEALTH ANNOUNCES REINTRODUCTION OF PROHEART 6 TO THE
U.S. VETERINARY MARKET
OVERLAND
PARK, Kan. (June 5, 2008) – Fort Dodge Animal Health, a division
of Wyeth (NYSE: WYE), today announced the reintroduction of ProHeart®6,
a unique heartworm preventative, to the U.S. veterinary market.
This announcement follows a review by the U.S. Food and Drug Administration’s
Center for Veterinary Medicine (CVM) of an extensive body of scientific
data and international experience, which support the decision to
return this life-saving product to the market.
“We
are extremely pleased to bring ProHeart 6 back to veterinarians
and pet owners throughout the United States, as it has safely and
effectively protected millions of dogs around the world against
potentially deadly heartworm disease,” says Rami Cobb, BVSc
(Hons), MACVSc, senior vice president of pharmaceutical research
and development for Fort Dodge Animal Health. “Our first and
foremost priority continues to be providing products that help ensure
the health and well being of all animals.
“At
the time of the voluntary U.S. recall in 2004, we believed it was
in the best interest of veterinarians and pet owners to thoroughly
address the concerns of the CVM before continuing the marketing
of this product in the United States. We have always maintained
our confidence in ProHeart 6 and the unique medical benefits it
brings to veterinary medicine. Fort Dodge has worked with the CVM
to address its questions, and feels the scientific data, as well
as our vast experience with the product internationally, supports
confidence in the product and its return to the U.S. market.”
For the
past seven years, Fort Dodge has provided the ProHeart family of
sustained-release products in a number of other countries, where
it has protected millions of dogs against this potential deadly
disease. It is marketed in major countries (Australia, the Mediterranean
regions of Europe and Japan) where heartworm infection is endemic
and a serious health risk for dogs. ProHeart products have achieved
substantial usage in all of these countries, and are the market
leader in both Australia and Italy.
ProHeart
6 is the only option for heartworm prevention in the United States
that helps ensure dogs are continuously protected against this potentially
fatal disease for six months following a single dose. The American
Heartworm Society (AHS) estimates as many as 27 million dogs in
the United States are not currently on a preventative – putting
a staggering number of dogs at risk for heartworm disease. Based
on a survey conducted by the AHS in 2005, the organization also
reports approximately 250,000 pets in the United States tested positive
for heartworm infection in 2004, which represents an increase of
nearly 5 percent over the number of pets that tested positive in
2001.
Because
ProHeart 6 is being returned to the U.S. veterinary market following
a voluntary recall, Fort Dodge will implement a post-marketing surveillance
initiative based on programs used to monitor the safety of human
drugs. The effort will include comprehensive veterinarian training,
pet owner education and consent forms, and specific requirements
for the purchase and administration of ProHeart 6. This program
will also allow the Company to gather additional product data and
maintain active communication with veterinarians and the CVM.
Practitioners
who purchase ProHeart 6 will also be required to communicate with
pet owners about the benefits and risks associated with the product.
This will include providing pet owners with a Client Information
Sheet and answering all client questions, as well as obtaining a
signed “Informed Consent” form from the pet owner before
the product is administered.
“While
Fort Dodge and other veterinary professionals have worked diligently
during the past few years to generate additional safety data to
support the return of ProHeart 6 to the U.S. market, this accomplishment
would not have been possible without the support of countless veterinarians
and pet owners who truly believe in this product and recognize the
benefits it brings to the dogs in our lives,” says Dr. Cobb.
Fort Dodge
Animal Health is a leading manufacturer and marketer of animal health
products for the livestock, companion animal, equine, swine and
poultry industries in North America and international markets. The
company has research and development facilities in Iowa and New
Jersey, and manufacturing facilities/offices in Brazil, Argentina,
Spain, Ireland, France, The Netherlands, Italy, India, Taiwan and
Australia. Its headquarters is in Overland Park, Kan.
About Heartworm
Disease
Heartworm
disease is a potentially deadly disease affecting the U.S. canine
population. Spread by mosquitoes, it can cause serious damage to
the heart and pulmonary arteries eventually leading to heart failure.
In severe cases, heartworm disease can damage other organs such
as the liver and kidneys. Clinical signs of heartworm disease may
not be recognized in the early stages, as heartworms may accumulate
gradually over a period of months and sometimes years. Heavily infected
animals may show clinical signs including mild, persistent cough,
reluctance to move or exercise, tiredness after only moderate exercise,
reduced appetite and weight loss. Prevention of heartworm disease
is the best alternative, as treatment can result in death, severe
allergic reactions or pulmonary embolism.
ProHeart®
6 is generally well tolerated. Do not use in sick, debilitated or
underweight animals, animals with a history of weight loss, or within
one month of vaccination. Use with caution in dogs with pre-existing
allergic disease. A small percentage of dogs showed mild, transient
swelling or itching at the injection site. While rare, allergic,
digestive, hematological, or neurological reactions may occur. In
addition, death has been reported. ProHeart 6 is available only
through a restricted distribution program. Only veterinarians enrolled
in this program can receive and administer ProHeart 6. In addition,
ProHeart 6 must only be administered to clients whose owners have
been advised of the risks of ProHeart 6 and sign an Owner Consent
Form. To obtain additional information including a copy of the product
labeling, visit the website at www.proheart6dvm.com
or call 1-800-533-8536.
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