Fort Dodge Animal Health
Division of Wyeth
9401 Indian Creek Parkway
Overland Park, KS 66210 |
Stephen A. Connell
Vice President
Professional& Technical Services
800-533-8536 |
June 19, 2003
Dear Doctor:
This letter is to provide another update of
our field experiences with ProHeart®
6 (moxidectin) as we pass the two year anniversary of its
launch, and some label additions being made to reflect some
of these experiences, as noted below. We trust that this information
will be useful and encourage you to call our Professional
Services department if you have any additional questions after
reviewing this material.
There are two additions to the ProHeart®
6 label that have either been made, or are in the process
of being made. The first was the label change regarding
use of ProHeart®6 in Heartworm-positive dogs. Briefly,
the changes were made in response to a low number of Heartworm-positive
dogs that experienced coughing or cardiopulmonary signs after
receiving ProHeart 6. The pre-approval clinical studies
did not identify any such reactions prior to release, and
many heartworm-positive dogs have received ProHeart®
6 without side effects However, based on reports received
on a low number of heartworm-positive dogs, Fort Dodge, in
conjunction with the Center for Veterinary Medicine, made
the following changes:
Under the heading "Post Approval Experience,"the
following statement was added:
"Cardiopulmonary
sign such as coughing and dyspnea may occur in heartworm-positive
dog treated with ProHeart® 6."
Additional labeling changes made under the
"Precautions" section of the package insert and printed
cartons in conjunction with this statement included:
1. Removal of the statement "At
the discretion of the veterinarian" before the sentence
"Infected dogs should be treated to remove adult heartworms."
2. The following statement was deleted
"No adverse reactions were observed in dog with patent heartworm
infections when ProHeart® 6 was administered at three
times the labeled dose. Higher doses were not tested."
(A similar statement was already present in the Animal Safety
section, and this statement was left unchanged.)
The second label change is the recent decision
to add a statement regarding the rare occurrence of
death in a low number of dogs treated with ProHeart®
6. Death has been reported in approximately 0.0025 percent
of the doses sold into veterinary clinics. Some of the reports
are associated with severe allergic events, while others appear
to be mulifactorial in nature. Some are linked to factors
not associated with the product use.
We continue to investigate all reports as
fully as possible. If and when further information becomes
available that has clinical implications on product use, we
will advise the veterinary community accordingly.
With regard to the label change, the following
new statement, "and rare reports of death" has been added
to the "Post-Approval Experience" section under the heading
"ADVERSE REACTIONS."" The full "Post-Approval Experience"
section now reads:
Post-Approval Experience: Although
not all adverse events are reported, the following
reactions are based on voluntary post-approval drug experience
reporting: anaphylaxis/toid reactions, depression/lethargy,
urticaria, head/facial edema, and rare reports of death, anaphylactic
and anaphyfactoid reactions should be treated immediately
with the same measures used to treat hypersensitivity reactions
to vaccines and other injectable products. Cardiopulmonary
signs such as coughing and dyspnea may occur in heartworm-positive
dogs treated with ProHeart® 6.
This revised "Post-Approval Experience" statement
will replace the current wording, which appears in the ProHeart®
6 package insert and on all approved ProHeart®
6 printed outer boxes.
In order to help educate your clients on both
the benefits and potential side effects associated with ProHeart®
6 (moxidectin), Fort Dodge Animal Health has prepared a client
information sheet which contains questions and answers about
use of the product, and includes the product insert on the
reverse side. An example copy is attached for your reference.Additional
quantities will be available to you through your Fort Dodge
representative and the sheet will soon by posted on our websites
for both veterinarians and clients to download and print.
Thank you for your attention to this important
information. We feel it is essential to provide you with timely
updates on the use of this product. Millions of doses of ProHeart®
6 continue to be used safely, and we trust that this reflects
your on-going experience, as well. We continue our monitoring
activities and will provide any pertinent updates on ProHeart®
6 as they become available. Please feel free to contact one
of our Professional Services veterinarians at the number listed
above if you have additional questions or concerns regarding
any of this information.
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