FDA orders label changes then withdrawal for ProHeart 6

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FDA orders label changes then withdrawal for ProHeart 6

Postby malernee » Mon Mar 29, 2004 6:46 am

FDA orders label changes for ProHeart 6




November 1, 2003
By: Jennifer Fiala
DVM Newsmagazine



Overland Park, Kan.-The U.S. Food and Drug Administration (FDA) has ordered label changes for ProHeart 6 (moxidectin), a six-month injectable heartworm preventive.

The label changes concern use of the product in heartworm-positive dogs and death, "in rare cases."

In accordance with FDA protocol, manufacturer Fort Dodge Animal Health sent letters to all U.S. practitioners in August outlining the label changes. The company explained that a "low number of heartworm positive dogs experienced coughing or cardiopulmonary signs after receiving ProHeart 6," as well as explaining the second change, "death has been reported in approximately 0.0025 percent of the doses sold in veterinary clinics (approximately 2.5 per 100,000 doses). Some of the reports are associated with severe allergic events, while others appear to be multifactorial in nature. Some are linked to factors not associated with product use." The FDA claims that nine of the 240 reported deaths are directly tied to the drug. The others could not be conclusively connected.

Overall, the company says, year-to-date reported adverse reactions are down 19 percent compared to last year.

By law, drug manufacturers must report all adverse reactions brought to their attention to the FDA.

"When this drug was initially marketed, it was believed to be safe for heartworm positive dogs; then we found that dogs were dying that were heartworm positive," says Dr. Victoria Hampshire, the FDA's adverse drug events coordinator.

She urges practitioners not to view Fort Dodge's letter as "junk mail."

"In the hustle and bustle of everyday practice, it's really important that veterinarians know what kind of dogs they're dealing with," Hampshire says. "The take-home message is to do a thorough physical exam before administering this drug."

In a written statement to DVM Newsmagazine, Fort Dodge stands by the safety and efficacy of its product.

"As is typical in the case of a new product after introduction to a wide population base, we have received reports that were not seen in pre-approval clinical studies." The label change, it says, is all part of FDA's post-approval experience. The product debuted in June 2001.

The statement adds, "We have been in regular correspondence with veterinarians regarding field reports. We have initiated adjustments to the label statements in conjunction with the FDA's Center for Veterinary Medicine, as necessary, to reflect that post-approval experience."

Veterinarians with questions about ProHeart 6 can contact a Fort Dodge technical services veterinarian at (800) 477-1365.

FDA's Annual and Cumulative Adverse Drug Experience Reports lists all adverse drug reports. Visit www.fda.gov/cvm-/index/ade/ade_webrpts.pdf for more information.
Last edited by malernee on Mon Sep 13, 2004 3:04 pm, edited 2 times in total.
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More on ProHeart6 heartworm medication

Postby gues » Mon Jun 07, 2004 7:25 am

http://wfrv.dayport.com/viewer/viewerpa ... egory_ID=5



Note in the last sentence the steady increase in use of the product by vets. OZ has removed the RX label from its oral and topical macrolid heartworm medication. The FDA is expected by many to do so. The public can now buy heartworm medication over the internet and no longer need to buy them from their vet. The injectable form of heartworm medication will not loose its RX.
gues
 

prothart 6 recall

Postby guest » Sat Jul 10, 2004 10:22 am

http://news4colorado.com/topstories/loc ... 60639.html
News 4 Investigates: Dog Heartworm Medication Under Microscope

Jul 8, 2004 8:06 pm US/Mountain
WINDSOR, Colo. (News 4) A drug approved to protect your dog is now under the microscope.

The Food and Drug Administration is investigating the drug ProHeart 6 because of the number of adverse reactions and deaths reported by veterinarians and dog owners. ProHeart 6 is an injectable medication that's supposed to protect against heartworm and kill parasites.

Veterinarians who offer ProHeart 6 treatments inject dogs every six months to prevent heartworms as part of the procedure. It's more convenient than monthly pills, but now thousands of pet owners are questioning its safety.

Veterinarian Robin Downing says she has one priority. "My job is to advocate on behalf of beings who cannot advocate for themselves," she said.

That's why Downing is now advocating that pet owners who come to her clinic in Windsor stop using ProHeart 6.

"We had several events that we thought were related to an adverse reaction to ProHeart 6," Downing said.

A Jack Russell terrier named Oscar is one of the animals Downing said suffered after receiving ProHeart 6.

Oscar's owners, Ryan and Megan Boothe, said Oscar started having daily seizures after getting the heartworm medication. Ryan Boothe said their dog would lay there for hours and hours and not even move, and his chest would be heaving.

Downing said Oscar is just one example.

Jean Brudd said all three of her dogs -- Nicki, Tasha and Casey -- all got shots of ProHeart 6 at a different clinic. Two died and one remains on medication.

"I didn't want to think the shot was responsible," Brudd said.

Nicki and Tasha died just months after getting shots to prevent heartworm. There has been no direct link found between their deaths and ProHeart 6, though. Brudd keeps their ashes by her bed and thinks about them constantly.

"I'm the only one who didn't have a shot in the household, and I'm the one who's not in a wooden box or on medication," Brudd said.

Downing said she saw enough problems with ProHeart 6 that she pulled the drug off her shelves. "Does ProHeart 6 really deserve a place in my practice from the perspective I have as a primary care provider? And our answer was, 'I don't think so.'"

More than 5,000 veterinarians and dog owners have filed complaints about ProHeart 6 with the FDA. Nearly 500 dogs have died after receiving an injection.

Since the drug became available two years ago, the FDA has required its maker to add safety information to the label.

The government also required ProHeart's manufacturer, Fort Dodge Animal Health, to write two letters to veterinarians alerting them of the label changes, which include warnings about the possibility of severe adverse reactions and in rare cases, death.

Fort Dodge maintains its drug is safe and that the number of adverse events reported to the FDA represents a fraction of total doses sold.

"It's a very low reaction rate in terms of millions and millions of doses that have gone into protect dogs against heartworm," Fort Dodge spokesperson Dr. Rami Cobb said. "We take every complaint very seriously. We investigate every individual animal with their veterinarian."

Cobb maintains that the number of doses given continues to rise as the number of adverse events reported falls, but many dog owners say they are steering clear of ProHeart 6.

"I'd have to be 6 feet under," Brudd said. "I would never use ProHeart 6 again."

In April, the manufacturer of the drug issued a recall for countless vials of ProHeart 6 because the drug did not meet FDA specifications.

The FDA says it will continue to investigate ProHeart 6.
guest
 

FDA's Request to Recall ProHeart 6 Injectable

Postby guest » Fri Sep 03, 2004 6:20 pm

FDA Talk Paper
T04-37
September 3, 2004
Media Inquiries: 301-827-6242
Consumer Inquiries: 888-INFO-FDA



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.
guest
 

fda prohart6 recall

Postby guest » Fri Sep 03, 2004 6:42 pm

Will be interesting to see if greedy vets and drug company that wanted a six month injection rather than a 12month one caused problems not seen in the 12month drug. Now fda rumors are about over the counter heartworm pills next year and vets may have no injectable heartworm medicine that only vets can sell. Theory of prohart6 problem is smaller size 6 is getting into circulation and causing problems where larger 12month heartworm injection sold in Australia is staying out of the circulation and having less side effects.
guest
 

forte dodge and vet only newsgroups ph6 recall talk

Postby whistle blower » Sat Sep 11, 2004 1:32 pm

Until now websites have generally been developed separately for patients and
doctors. As Muir Gray, codirector of the UK's National Electronic Library
for Health, points out, this is absurd. Doctors and patients need the same
evidence based information, served up in parallel, drawn from the same sources.
Here are some quotes from a website were only vets who are members and drug
reps like those of FD are allowed to draw information from.

quotes below are from a website where vet members and forte dodge gather
away from the publics eyes and post about prohart six fda withdrawal. I took
out everyones name but the technical services manager from FD and FD PH6
Consultant.
good luck,
art malernee dvm
****

"Are none of you aware of the organized group of "consumers" who have made
their business to make sure that Proheart6 is off the U.S. market? At this time
I know similar groups for rimadyl and deramaxx. These people do not
understand scientific evaluation nor are they particularly interested in an accurate
picture of information. With these people constantly seeking media attention
etc. and recruiting anyone whose dog has so much as skipped a meal once while
on Proheart6, I am not surprised if there was a gag order or some sort on a
settlement. I am wondering how much influence this group had on the FDA and
how many ADE reports they are responsible for.
***
What those groups want, is for Rimadyl and Deramaxx to be taken off the
market.
****
The Senior dogs website is one such group that works to "inform" the public
of the reactions associated with certain drugs. You can view the site at
www.srdogs.com
Specifically, the Rimadyl page is here:
_http://www.srdogs.com/Pages/rimadyl.rec.html_
(http://www.srdogs.com/Pages/rimadyl.rec.html)
***
IT IS A PETMED CONSPIRACY!! THIS WAY THEY CAN TRY AND ELIMINATE PROHEART AS
THEIR COMPETITION PUSHING PEOPLE TOWARDS HEARTGARD!
****
We had a Fort Dodge rep in JUST LAST WEEK to conduct a Proheart marketing
meeting for the staff. On Thursday my office manager was on the phone with her
continuing the discussion.
****
I reassured the client that Proheart6 was safe to use in healthy dogs but
like all medications, ran a slight risk of reaction (which we have not
experienced at the practice I'm with). The client, reassured, went ahead and updated
his Proheart on 2 dogs
****
We, in turn, sell our clients on your products. They buy Fort Dodge products
because WE recommend them.
Veterinarians do not buy from manufactures because one's test data is
superior to anothers on competitive products. Veterinarians buy from the
manufactures who take care of the veterinarian.
*****
I emailed a vet in AU and they have the Proheart SR 12 (a once a year HW
prev) that has not gone through the recall. He didn't even know about the recall
here or reactions
***
I'd like to know why the Australian Proheart 12 isn't available here
***
My name is Raphael Zwijnenberg. I'm the technical services manager from FD in
Australia. I would like to include you in our mailings
*****
Could you let us know if there is any concern about Proheart SR12
****
I think we all need to ask ourselves some (one) hard question: Did we use
ProHeart because we really feel it was in the best interest of our
clients/patients, or was it motivated primarily by the profit & getting them in twice a
year?
Methinks, in most cases, 'twas the latter. It is a clearly inferior product,
with risks over the monthlies, as previously noted on XXX and elsewhere.
Heck, the whole reason it came out as a 6 month injection rather than 12 was
because Ft. Dodge's studies showed veterinarians preferred that simply to get
them in the clinic twice a year!
****
I know of several cases of dogs that died from proheart 6 adverse reactions
where Ft Dodge setteled out of court with the owners and
PUT A GAG ORDER AS PART OF THE SETTLEMENT. Why the gag orders?
****
I had used Proheart 6 for a year and a half at my previous practice and had
only had a couple adverse reaction that I knew of in all that time that I
could link with Proheart. In retrospect, I could probably link more, but wasn't
looking for it.
***
I would like to clarify--it is my understanding that we are not violating
anything if we use the stock we have,
****
for one am giving FD the benefit of the doubt for now about the way this
product was recalled. FD sincerely believed that the FDA had mis-interpreted the
data and tried to respond to the FDA's concerns. During this period FDAH was
specifically forbidden by the FDA from giving us a head's up.
Philip McHugh, DVM
FD PH6 Consultant
***
I agree with Philip. Why not give FD the benefit of the doubt until all the
facts are in? I have been using PH for 2 years and have seen maybe 2
reactions
****
I am telling my clients that the FDA is just being conservative, as usual,
and investigating for adverse reactions. I will give PH again when it is
re-released.
****
Someone will have to show me some actual evidence to prove that it is a
dangerous drug.
****
try emailing the FDA Center for Veterinary Medicine at _CVMHomeP@cvm.fda.gov_
(mailto:CVMHomeP@cvm.fda.gov) with the complaint of making us as a
profession look like idiots...
****
I, too think that there is more here than meets the eye. Some collusion
among FD's competitors? The Novartis letter seems fishy and I wouldn't be
surprised that Petmeds may be involved too.
***
I agree. I like Proheart. The first dog we treated had anaphylaxis but
responded well (about 2 years ago I believe). It became our number one heartworm
preventative
****
I came in Tueasday AM early to help out with boarders going home from a long
week end and I find a fax fron Novartis informing me of Ft. Dodge's recall of
Proheart.
***
I was just talking to a friend who is a competitor of FD, He said that his
bosses knew on wednesday about this. Even if FD didn't know until friday
evening, you would think that they would have had a 3 day weekend to have a plan
on what to do. "
whistle blower
 

AVMA, Fort Dodge Partner to Promote

Postby guest » Sat Sep 11, 2004 7:29 pm

http://www.dogfancy.com/dogfancy/detail ... 84&search=

AVMA, Fort Dodge Partner to Promote Biannual Pet Checkups
Aug. 17, 2004



The American Veterinary Medical Assn. and animal health care product manufacturer Fort Dodge Animal Health have teamed up to promote October as National Pet Wellness Month.



The two-pronged educational campaign, which focuses on the pet aging process and emphasizes the need for twice-a-year wellness exams, will target both veterinarians and pet owners.



The first stage of the program, which will be a multi-year venture for the two groups, centers on local veterinary clinics. Veterinarians can request educational tools, such as brochures and posters, which will be shipped to the participating clinics free of charge.



The second stage, taking place during October, will feature a series of national print, television and radio spots directed at pet owners. The publicity campaign, running under the heading “Twice a year for life!”, will direct pet owners to their veterinarians for more information. The campaign emphasizes the notion that because pets age faster than humans, they require more frequent check-ups with their veterinarians.



The AVMA and Fort Dodge report that according to a survey of 800 pet owners and 400 veterinarians, 61 percent of pet owners say their pets’ health is as important as their own.



The survey also found that the average pet owner currently visits the veterinary clinic 1.9 times a year. Since 1996, the mean number of visits for dogs has increased 6 percent, and the mean number of visits for cats is up 11 percent.



“We firmly believe creating greater knowledge and awareness of twice yearly pet wellness exams will have a dramatic impact on the health, quality of life and longevity of America’s pets,” said Brent Standridge, Fort Dodge’s senior vice president of sales and marketing in North America. “And the best place for pet owners to learn about the pet aging process and wellness exams is from their veterinarian.”



Veterinarians participating in the program are encouraged to tailor twice-a-year visits to the individual needs of each animal by setting up six-month immunization and procedure protocols for each pet.



“An exam every six months is the best way to ensure that any potentially life-threatening condition is caught early,” said Jack Walther, DVM, immediate past president of the AVMA.
guest
 

Heartworm Medicine Linked To Sickness, Death

Postby malernee » Sat Sep 18, 2004 7:20 pm

nbc5i.com
Heartworm Medicine Linked To Sickness, Death
FDA Receives More Than 5,000 Adverse Reaction Reports
POSTED: 3:21 PM CDT May 25, 2004


A new heartworm medication called ProHeart 6 has been linked to a number of dog deaths, an NBC 5 investigation finds.



Heartworm Meds Linked To Death


Since it was approved in May 2001, the U.S. Food and Drug Administration has received more than 5,000 reports of adverse reactions -- 491 of them deaths.

Now, the FDA is investigating.

Debra McMullen has other dogs now, but says none can take the place of Sassy, the Chihuahua who moved across the country with her.

"She was my baby. I don't have children, so she was my baby," McMullen said.

After using monthly heartworm prevention tablets she sometimes forgot, McMullen asked her veterinarian about the six-month injection called ProHeart 6.

She wondered if her 11-year-old dog was too old.

"And he said, 'No, that shouldn't matter. She's fine.' And he gave her the shot and the very next day she started having breathing problems," McMullen said.

Two weeks later, Sassy was dead.

Chief was dead just days after his only ProHeart 6 injection, according to his owner. Eric Williams raised the 9-year-old Rottweiler from a pup.

"For a completely healthy dog, in the space of three or four days, to go through what I saw Chief go through is not right," Williams said.


Canine Heartworm Medication Adverse Reaction Comparisons
(Source, FDA, As of 5/03/2004)

Drug Total Adverse Reactions Total Deaths Year Approved Avg. Reactions Avg. Deaths Form

ProHeart 6
(Moxidectin): 4499 415 2001 1500 138 Injection

Revolution
(Selamectin): 8695 181 1999 1737 36 Topical

Interceptor
(Milbemycine oxime): 1922 84 1995 214 9 Oral

Heartguard
(Ivermectin/Pyrantel): 2840 51 1996 355 6 Oral

Sentinel
(Milbemycine oxide/luferon): 892 25 1999 233 6 Oral



FDA figures show the number of ProHeart 6 adverse reaction reports of deaths to be much higher than monthly heartworm medications -- an average of 138 a year compared with as few as 6 for Heartgard and Sentinel.

Chief had tested positive for heartworms before receiving ProHeart 6 in May 2002.

Manufacturer Fort Dodge Animal Health has since strengthened label warnings against using the preventive on dogs already carrying the parasite.

During the past two years, the FDA has ordered three label changes and two "Dear Doctor" warning letters about possible adverse reactions.

Experts say the concern is that the medication is a highly concentrated, microencapsulated drug that must be mixed in suspension for time release inside the animal's body.

"[It] needs to be administered properly. It needs to be prepared properly," said Dr. Bert Childers, a veterinarian with the Society for the Prevention of Cruelty to Animals.

Childers has used ProHeart 6 in the past without trouble, and still considers it safe. But his SPCA clinic does not dispense it, in favor of monthly treatment.

"You can stop, and you don't have another 4 months left in the body that you have to contend with," he said.

The company says dogs would be in greater danger missing heartworm treatment.

According to Fort Dodge, adverse reaction reports are less than one percent of more than 14 million doses given, and that most death reports are not actually proven to be from ProHeart 6.

In fact, Sassy and Chief were cremated. Their owners can prove nothing with only their ashes. And both their veterinarians told them ProHeart 6 was not the cause.

However, independent veterinarians told NBC 5 that the symptoms suggest otherwise.

"This is probably an adverse reaction from that," Childers said.

"Stop the sale until they find out what's going on," Williams said.

Meanwhile, the FDA says it is "actively" investigating.

The FDA also recommends that pet owners should talk to their vet and read current warnings carefully before deciding which treatment to use.

For more information, or to report adverse reactions, please refer to the links below.


--------------------------------------------------------------------------------
Resources
--------------------------------------------------------------------------------
On The Net: FDA Veterinary Adverse Reaction Reporting
On The Net: Current ProHeart6 Product Label
On The Net: ProHeart6 FAQ
FDA-Required "Dear Doctor" Letters From Fort Dodge:
Letter 1 | Letter 2
On The Net: FDA ProHeart 6 Application Information
On The Net: FDA ProHeart6 Supplemental Information
On The Net: Heartworm Information
Copyright 2004 by nbc5i.com. All rights reserved. This material may not be published, broadcast, rewritten or redistributed.
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fda prohart6 dear doctor letter

Postby malernee » Tue Sep 21, 2004 12:38 pm

http://www.fda.gov/cvm/index/safety/pro ... 91304.html
FDA Home Page | CVMHome Page | CVM A-Z Index | Contact CVM | SIte Map
Important Drug Information about ProHeart® 6
September 13, 2004
Dear Doctor:
FDA has requested that Fort Dodge Animal Health, Inc., recall
ProHeart® 6 (moxidectin) Sustained Release Injectable for Dogs to the
veterinarian. Since the product was approved in June 2001, the FDA
Center for Veterinary Medicine (CVM) has received over 5,000 reports of
adverse reactions suspected of being associated with ProHeart® 6. Many
of the reports received have involved serious, life-threatening adverse
events, such as anaphylaxis, convulsions, hematopoetic disorders, and
hepatopathies, followed in some cases by death. FDA has also evaluated a
number of adverse drug reports associated with ProHeart® 6 that
include neurologic problems and unusual cardiac signs.
Due to the seriousness of these reports, we advise you to discontinue
administration of ProHeart® 6 until further notice. Pet owners should
be advised on appropriate alternative heartworm preventatives for their
dogs.
At FDA's request, the product sponsor has also made three label
revisions, added a Client Information Sheet, and issued two "Dear
Doctor" letters since approval to advise veterinarians and pet owners of
the risks associated with use of the product. Despite these label
changes and educational efforts, FDA is still receiving an alarming
number of unexplained adverse event reports. 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 as well
as the mandatory reporting of adverse events by Fort Dodge Animal
Health. The actual incidence of adverse events is likely to be even
higher than reported, because studies show that only a fraction of
actual adverse reactions are reported. FDA is requesting that Fort Dodge
Animal Health conduct research to determine the cause of the adverse
reactions and develop a strategy to help prevent such problems before
the product is marketed again.
We consistently encourage veterinarians to report adverse events through
the product sponsor. Sponsors are then obligated to submit their reports
to CVM. Adverse events may also be reported directly to CVM by
submission of Form 1932a (
http://www.fda.gov/opacom/morechoices/f ... -1932a.pdf ) or by
use of our hotline:
1-888-FDA-VETS. Adverse events for veterinary patients submitted to the
FDA are routinely updated on the CVM web site (
http://www.fda.gov/cvm/index/ade/ADEReport.htm ).
We will continue to serve veterinarians and their clients by providing
updated, accurate, and unbiased information with respect to the safe and
effective use of veterinary pharmaceuticals.

Sincerely,
Stephen F. Sundlof, D.V.M., Ph.D.
Director
FDA Center for Veterinary Medicine
CVM Home Page | CVM A-Z Index | Contact CVM | SIte Map
FDA Home Page | Search FDA Site | FDA A-Z Index | Contact FDA | HHS Home
Page
FDA/Center for Veterinary Medicine
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Lawsuit Filed against ft dodge Manufacturer of ProHeart

Postby malernee » Wed Sep 29, 2004 6:57 pm

NEWS RELEASE Contact: Deborah Howard: 970-223-3800
Dennis Dill:
405-359-0600
NEWS RELEASE Contact: Deborah Howard: 970-223-3800
Dennis Dill:
405-359-0600
Lawsuit Filed against Manufacturer of ProHeart®6 Heartworm Medication
Complaint Alleges Fort Dodge Animal Health, a Division of Wyeth, Failed to
Warn Consumers of Possible Serious Adverse Reactions, including Death, to Dogs
from Sustained-Release Preventative Shot


EDMOND, Oklahoma - September 27, 2004 - Dennis Dill, an attorney with Chris
Harper, Inc., a multi-practice law firm in Edmond, Oklahoma filed a lawsuit
against American Home Products, Wyeth and Fort Dodge Animal Health in Tulsa,
Oklahoma District Court on September 22, 2004.

The lawsuit alleges that American Home Products, Wyeth and Fort Dodge Animal
Health recklessly introduced ProHeart®6, an injectable heartworm preventative
medication, to the market without giving consumers proper warning that their
product could cause serious health risks or even death to canines.

On September 3, 2004, the FDA recalled ProHeart®6. This recall received
extensive media coverage. Fort Dodge, at the request of the FDA, is also ceasing
production while continuing to conduct research to determine the cause of
related adverse reactions. The FDA also instructed the company to 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.

Chris Harper, Inc. has asked the Court for a class action status due to the
numerous complaints that have been filed with the FDA Center for Veterinary
Care, which is estimated at over 5,000 throughout the United States (around 10
percent are deaths).

The Plaintiff in this lawsuit is June Dill, an 80-year-old grandmother who
took her companion, "Baby," an 8-year-old Yorkshire Terrier, to a local
veterinarian for a preventative check-up. After being told that ProHeart®6 was a
safe, preventative heartworm medication, she allowed the vet to inject "Baby" with
ProHeart®6. It is alleged in the Petition that due to the injection of
ProHeart®6, in just a few short weeks, "Baby" died as a result of complications
caused by ProHeart®6.

Chris Harper, Inc. has filed this Petition to assist pet owners, such as June
Dill, who have either had their companions injured or watched them pass away
due to the complications of ProHeart®6.

To date, the Companion Animal Protection Society (CAPS), a national animal
protection organization based in Fort Collins, Colorado, has gathered around 90
complaints from people whose dogs have become very ill or died after receiving
a ProHeart®6 shot. The most common reactions listed in these complaints are
seizures, liver problems, Immune Mediated Hemolytic Anemia (IMHA), Hemorrhagic
Gastroenteritis (HGE) and Thrombocytopenia Vasculitis. CAPS has been
generating news stories around the country that feature consumers whose dogs suffered
adverse reactions, including death, after receiving ProHeart®6. You can read
more about ProHeart®6 on the CAPS website: www.caps-web.org.
END QUOTE

See also: http://www.caps-web.org/images/Proheart ... elease.pdf
Heartworm Medication
Complaint Alleges Fort Dodge Animal Health, a Division of Wyeth, Failed to
Warn Consumers of Possible Serious Adverse Reactions, including Death, to Dogs
from Sustained-Release Preventative Shot


EDMOND, Oklahoma - September 27, 2004 - Dennis Dill, an attorney with Chris
Harper, Inc., a multi-practice law firm in Edmond, Oklahoma filed a lawsuit
against American Home Products, Wyeth and Fort Dodge Animal Health in Tulsa,
Oklahoma District Court on September 22, 2004.

The lawsuit alleges that American Home Products, Wyeth and Fort Dodge Animal
Health recklessly introduced ProHeart®6, an injectable heartworm preventative
medication, to the market without giving consumers proper warning that their
product could cause serious health risks or even death to canines.

On September 3, 2004, the FDA recalled ProHeart®6. This recall received
extensive media coverage. Fort Dodge, at the request of the FDA, is also ceasing
production while continuing to conduct research to determine the cause of
related adverse reactions. The FDA also instructed the company to 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.

Chris Harper, Inc. has asked the Court for a class action status due to the
numerous complaints that have been filed with the FDA Center for Veterinary
Care, which is estimated at over 5,000 throughout the United States (around 10
percent are deaths).

The Plaintiff in this lawsuit is June Dill, an 80-year-old grandmother who
took her companion, "Baby," an 8-year-old Yorkshire Terrier, to a local
veterinarian for a preventative check-up. After being told that ProHeart®6 was a
safe, preventative heartworm medication, she allowed the vet to inject "Baby" with
ProHeart®6. It is alleged in the Petition that due to the injection of
ProHeart®6, in just a few short weeks, "Baby" died as a result of complications
caused by ProHeart®6.

Chris Harper, Inc. has filed this Petition to assist pet owners, such as June
Dill, who have either had their companions injured or watched them pass away
due to the complications of ProHeart®6.

To date, the Companion Animal Protection Society (CAPS), a national animal
protection organization based in Fort Collins, Colorado, has gathered around 90
complaints from people whose dogs have become very ill or died after receiving
a ProHeart®6 shot. The most common reactions listed in these complaints are
seizures, liver problems, Immune Mediated Hemolytic Anemia (IMHA), Hemorrhagic
Gastroenteritis (HGE) and Thrombocytopenia Vasculitis. CAPS has been
generating news stories around the country that feature consumers whose dogs suffered
adverse reactions, including death, after receiving ProHeart®6. You can read
more about ProHeart®6 on the CAPS website: www.caps-web.org.
END QUOTE

See also: http://www.caps-web.org/images/Proheart ... elease.pdf
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Long-term delivery of ivermectin microparticles in dogs

Postby malernee » Tue Oct 19, 2004 12:47 pm

1: Am J Vet Res. 2004 Jun;65(6):752-7.Related Articles, Links Long-term
delivery of ivermectin by use of
poly(D,L-lactic-co-glycolic)acid microparticles in dogs. Clark SL,
Crowley AJ, Schmidt PG, Donoghue AR, Piche CA. PR Pharmaceuticals Inc,
1716 Heath Pkwy, Fort Collins, CO 80525, USA. OBJECTIVE: To evaluate the
potential utility of poly(D,L-lactic-co-glycolic)acid (PLGA) as a
long-acting biodegradable drug delivery matrix for ivermectin used in
the prevention of heartworm disease in dogs. ANIMALS: 30 adult female
dogs. PROCEDURE: Microparticle formulations containing 25 weight percent
(wt%), 35 wt%, and 50 wt% ivermectin were prepared by an oil-in-water
emulsion technique with solvent extraction into excess water. A fourth
formulation, consisting of a mixture of 15 wt% and 50 wt% ivermectin
microparticles, was blended in a 1:1 ratio to result in a 32.5 wt%
ivermectin formulation. Formulations were administered once on Day 0 to
groups of 6 dogs at a dose of 0.5 mg of ivermectin/kg, s.c. Half of the
dogs in each treatment group and 3 untreated control dogs were infected
with Dirofilaria immitis larvae 121 and 170 days after treatment. Six
months after infection, dogs were euthanatized and necropsies were
performed. Pharmacokinetics and efficacy were investigated. RESULTS:
Analysis of pharmacokinetic data revealed sustained release of
ivermectin during at least 287 days in 3 distinct phases: a small
initial peak, followed by release of drug through diffusion, and polymer
degradation. Untreated control dogs were all infected with heartworms.
Heartworms were not found in any of the dogs in the ivermectin-PLGA
treated groups. Adverse clinical signs were not observed. CONCLUSIONS
AND CLINICAL RELEVANCE: All formulations were 100% effective in
preventing development of adult heartworms. Results indicate that PLGA
microparticles are a promising drug delivery matrix for use with
ivermectin for the prevention of heartworm disease for at least 6 months
after treatment.
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moxidectin neurotoxicosis

Postby guest » Sun May 01, 2005 7:33 am

Development of a PCR-based diagnostic test detecting a nt230(del4) MDR1 mutation in dogs: verification in a moxidectin-sensitive Australian Shepherd.
J Vet Pharmacol Ther 28[1]:95-9 2005 Feb

Geyer J, Doring B, Godoy JR, Moritz A, Petzinger E
Institute of Pharmacology and Toxicology, Faculty of Veterinary Medicine, Justus-Liebig-University of Giessen, Giessen, Germany.
A subpopulation of dogs of the Collie and Australian Shepherd breeds show increased sensitivity to central nervous actions of ivermectin, doramectin, loperamide, and probably several other drugs. The molecular background for this greater sensitivity is a nonsense mutation in the MDR1 efflux pump, which is part of the functional blood-brain barrier and normally limits drug penetration into the brain. This report describes a rapid PCR-based method for detection of this nt230(del4) MDR1 mutation using a small amount of genomic DNA from blood cells. Thereby, homozygous intact, homozygous mutated, and heterozygous mutated MDR1 genotypes can be clearly differentiated by high resolution polyacrylamide gel electrophoresis. Using this diagnostic test two Collies and one Australian Shepherd were screened for the nt230(del4) MDR1 mutation. The Collies had no history of altered drug sensitivity and showed homozygous intact and heterozygous mutated MDR1 alleles, respectively. However, the Australian Shepherd developed clear signs of neurotoxicity including ataxia, crawling, acoustic and tactile hyperexcitability, and miosis after a single dose of moxidectin (400 mug/kg). For this dog two mutated MDR1 alleles were detected. This report describes for the first time moxidectin neurotoxicosis in a dog with a homozygous MDR1 mutation.
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Efficacy of sustained-release formulation of moxidectin

Postby malernee » Mon Jul 25, 2005 8:28 am

Efficacy of an injectable, sustained-release formulation of moxidectin in preventing experimental heartworm infection in mongrel dogs challenged 12 months after administration.
Vet Parasitol 128[1-2]:129-35 2005 Mar 10

Lok JB, Knight DH, Nolan TJ, Grubbs ST, Cleale RM, Heaney K
Department of Pathobiology, School of Veterinary Medicine, University of Pennsylvania, Philadelphia, PA 19104-6050, USA. jlok@vet.upenn.edu
The objective of this study was to ascertain the ability of a single subcutaneous injection of a sustained-release (SR) formulation of moxidectin to protect dogs against challenge inoculation with infective Dirofilaria immitis larvae 364 days after administration. Twenty four purpose-bred adult mixed-breed dogs were grouped into three blocks of eight based on weight and sex. Saline solution (0.9% NaCl) or a moxidectin SR formulation at volumes designed to deliver 0.17 or 0.27 mg moxidectin/kg b.w. was injected subcutaneously on day 0. Throughout the post-treatment period, injection sites of all dogs were periodically examined visually and by palpation. Palpable swellings were characterized as to size, consistency and the presence of associated pain or erythema. On day 364, each dog was inoculated subcutaneously with 50 D. immitis L3. On days 510 and 511, dogs were euthanatized, and their hearts, lungs and thoracic cavities were inspected for the presence of adult heartworms. number, sex and viability of recovered heartworms were determined. The mean number of heartworms recovered from dogs that had received the saline control injection was 35.7. No heartworms were recovered from any dog treated with either 0.17 or 0.27 mg moxidectin/kg b.w. For variable periods of time following treatment, small (1-4 mm diameter), firm, subcutaneous swellings could be palpated at the injection sites of dogs treated with 0.17 or 0.27 mg moxidectin/kg b.w. These swellings contracted progressively and eventually disappeared except for the case of one animal treated with 0.27 mg/kg, in which the swelling persisted for the entire study period. At no time during the study was pain or erythema noted at the injection site of any dog, and no dog exhibited any adverse systemic reaction related to treatment. We conclude that under conditions pertaining in this study, a single subcutaneous injection of a moxidectin SR formulation at dosing rates of either 0.17 or 0.27 mg/kg b.w. can safely protect adult dogs against experimental challenge inoculation with infective heartworm larvae for a period of 12 months.
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FDA and Wyeth Misconduct of Dr. Hampshire prohart6

Postby guest » Sat Nov 19, 2005 5:29 pm

Senator Grassley Investigates Charges of FDA and Wyeth Misconduct
November 18, 2005


FOR IMMEDIATE RELEASE
Contact: Dylan Blaylock, Communications Director
Phone: 202.408.0034 ext. 137, cell 202.236.3733
Email: dylanb@whistleblower.org


Senator Grassley Investigates Charges of FDA and Wyeth Misconduct
Investigation Stems From FDA Veterinarian/GAP Client’s Removal from Case

Washington, D.C. – Yesterday on the Senate floor, Senate Finance Committee Chairman Charles Grassley (R-Iowa) announced that he is investigating charges that Wyeth Pharmaceuticals smeared an FDA safety officer who negatively reviewed one of Wyeth’s animal care products, and that the FDA subsequently removed her from that product’s review. Dr. Victoria Hampshire, the safety officer, “concluded that Wyeth’s drug (ProHeart6) was killing hundreds of dogs,” according to Sen. Grassley.

ProHeart6 is a heartworm disease prevention drug for canines. Sen. Grassley was marking the one-year anniversary of pharmaceutical giant Merck’s removal of its arthritis drug Vioxx from the market after it was found to substantially increase the risk of heart attacks. Dr. Hampshire is represented by the Government Accountability Project, the same nonprofit law firm that represents Dr. David Graham, the FDA scientist whose Senate testimony prompted the Vioxx removal.

You can read Sen. Grassley entire floor speech on GAP’s Web site at http://www.whistleblower.org/template/p ... age_id=140.

Sen. Grassley also announced that he sent a letter to Wyeth Pharmaceuticals, which at one point states “Information and documents reviewed by the Committee appear to support allegations that Wyeth investigated an employee of the FDA involved in the safety review of ProHeart6. It appears that the express purpose of the investigation was to discredit the employee and have the employee reassigned. Further, following the investigation conducted by Wyeth, the FDA initiated an internal criminal investigation into the same FDA employee. The Committee’s review of these allegations raises serious questions regarding, among other things, the appropriateness of the actions taken by both the FDA and Wyeth.”

You can read Grassley’s entire letter in full on GAP’s Web site at http://www.whistleblower.org/template/p ... age_id=141.

GAP Food & Drug Safety Director Mark Cohen, Hampshire’s attorney, stated “Senator Grassley’s investigation shows that Wyeth went into the gutter to smear Dr. Hampshire and the FDA buckled. Dr. Hampshire is a team player and all she wants is to be allowed to do her job with integrity.”

Dr. Hampshire is not making any statements until she receives approval from the FDA to speak publicly regarding the matter.
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Who is Victoria Hampshire? Issues Regarding Informed Consent

Postby guest » Wed Nov 23, 2005 4:24 pm

For your information: Please contact Senator Grassley and the FDA CVM in support of Victoria Hampshire if you see fit to do so, and pass this on.
http://grassley.senate.gov/webform.htm
http://www.fda.gov/comments.html

Who is Victoria Hampshire?

Hampshire, Victoria. Emerging Issues Regarding Informed Consent. javma News, 01/15/2004. http://www.avma.org/onlnews/javma/jan04/040115f.asp

Hampshire, Victoria. How CVM Uses Adverse Drug Experience Reports System. FDA Veterinarian, 2004 October; Vol. XIX, No. V. http://www.fda.gov/cvm/Documents/Sep-Oct04.pdf

FDA CVM Fort Dodge Document. Report of FDA Center for Veterinary Medicine to the Veterinary Medicine Advisory Committee (VMAC) concerning the Heartworm Preventative ProHeart6®. http://www.fda.gov/cvm/Documents/cvmFor ... cument.pdf

Public Record - Please crosspost widely!
Floor Statement of U.S. Senator Chuck Grassley of Iowa - One-Year
Anniversary of the Finance Committee’s Hearing on the FDA and Vioxx

WASHINGTON, November 17, 2005 - Mr. President, I rise today on the
anniversary of the hearing on the worldwide withdrawal of Vioxx, the blockbuster
drug
that became a blockbuster disaster. As chairman of the Committee on Finance, I
called for this hearing a year ago. The Vioxx hearing turned the spotlight on a
troubled agency in denial. The type of problems exposed during the hearing
have proven to be not isolated but systemic.



Over the past year, my Committee staff have investigated allegations coming
from within and without the agency. Brave whistleblowers – such as Doctors
Andrew Mosholder, David Graham and others – have come forward to expose the
too
cozy relationship between the agency and the drug industry. I can tell you today

that problems exist not only within the Center for drugs, but extend to the
Centers for devices, biologics and even to veterinary medicines. I am concerned
and every other member of this Senate should also be concerned.

To further illustrate this problem, I am sending today a letter to another
drug company that appears too cozy with the Food and Drug Administration. Last
year, just two days after the Vioxx hearing, the drug company Wyeth met with
former Commissioner Crawford. Why did Wyeth’s CEO want to talk with the
Commissioner? Because Wyeth recently had to remove one of its most profitable
veterinary drugs from the market.

So what did Wyeth do? They launched an investigation of an FDA employee, Dr.
Victoria Hampshire. You see, it was Dr. Hampshire who concluded that Wyeth’s
drug was killing hundreds of dogs. I have in my hand what Wyeth presented to
former Commissioner Crawford. It’s a 29-page power point with 10 pages of back

up materials, dated November 19, 2004. It’s marked “confidentialâ€
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