FDA Talk Paper
September 3, 2004
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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.


http://www.fda.gov/bbs/topics/ANSWERS/2 ... 01312.html
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US senator says Wyeth targeted FDA reviewer on dog meds
17 Nov 2005 22:46:16 GMT

Source: Reuters

By Lisa Richwine

WASHINGTON, Nov 17 (Reuters) - Drugmaker Wyeth <WYE.N> tried to discredit a Food and Drug Administration scientist who linked the company's withdrawn heartworm treatment to the deaths of hundreds of dogs, a U.S. Republican senator charged on Thursday.

Senate Finance Committee Chairman Charles Grassley said the FDA employee, Victoria Hampshire, approached his staff "because she was scared and felt unfairly targeted by Wyeth and her agency for simply doing her job."

Wyeth staff met with then-FDA Commissioner Lester Crawford a year ago and alleged that Hampshire had "personal and financial conflicts of interest" related to her review of the heartworm drug Proheart 6, Grassley said in a Senate floor speech.

The Iowa Republican said Wyeth "succeeded in having Dr. Hampshire removed from reviewing its drug."

The FDA launched a criminal investigation of Hampshire but took no action and eventually rewarded her for her work on the drug, Grassley said, adding that agency staff had briefed his committee on the matter.

A Wyeth spokesman had no immediate comment, and an FDA spokeswoman did not immediately respond to a request for a response to Grassley's charges.

Hampshire did not reply to an e-mail asking for comment, and she could not be reached by phone.

Grassley said he sent Wyeth a letter on Thursday asking the company for information and documents related to its investigation of Hampshire and comments by a Wyeth salesperson who "attempted to discredit Dr. Hampshire in the veterinary community."

Wyeth voluntarily pulled Proheart 6 from the U.S. market in September 2004, after thousands of reports of serious side effects, and the death of 600 dogs.

Grassley has been a vocal critic of the FDA and its relationship with the pharmaceutical industry. His committee has investigated the agency's oversight of several medicines, including Merck & Co. Inc.'s <MRK.N> withdrawn arthritis pill Vioxx.

He said the Wyeth case is another example of a company "that appears too cozy with the FDA."

I don't know why Senator Grassley comes to that conclusion: After reading that article, it appears that the FDA investigated the charges, found them to be baseless, and in fact gave an award to the person that Wyeth accused of impropieties.

What would Senator Grassley have the FDA do, ignore the charges?

Maybe the article was poorly written, and there's more than what meets the eye.
http://www.washingtonpost.com/wp-dyn/co ... 01883.html

"Hampshires difficulties were documented on the
Senate floor last winter by Sen. Charles E.
Grassley (R-Iowa).

Wyeth maintains that it
simply gave the FDA potentially troubling
information it found on a Web site about a
possible conflict of interest involving
Hampshire." She was selling competitors

Grassley continues to turn us into a police
state with his witch hunt at Wyeth for
reporting Hampshire's web site to the
FDA as a possible conflict of interest.

She was SELLING a competive product of the
one she was investigating???

FDA's investigative procedure is a joke,
it is based on the number of dog deaths, no
consideration of the number of doses given.
In the case of Proheart 500 deaths out of
18,000,000 doses? penicillin caused more
deaths per dose among humans, but FDA took
proheart off the market.

I think we have the best Politicians money
can buy.

Question is who is paying Grassley to help turn us to a police state???.

Proheart was easy and safe, my dog was
fine, no pills every day to forget, just
One shot every 6 months."death has been
reported in approximately 0.0025 percent of
the doses sold in veterinary clinics
(approximately 2.5 per 100,000 doses"

http://evidencebasedvet.com/forum/viewt ... t=proheart

"It's a very low reaction rate in terms of
millions and millions of doses that have
gone into protect dogs against heartworm,"
http://www.cafepharma.com/ubbthreads/sh ... t=all&vc=1

millions of doses and 500 deaths , grow up,
its safer than penicillin for humans,

Penicillin: Adverse Reactions
Severe penicillin hypersensitivity with
anaphylactic shock is very rare and occurs
mostly in connection with parenteral
administration (5 to 10 cases on 10000
treated subjects). The emergency treatment
is based primarily on adrenaline (and, in
addition, maybe intravenous
corticosteroids, aminophylline).

However, hypersensitive skin reactions
(skin rashes, urticaria) are frequent (1 to
7% of the treated subjects). High
concentrations of cerebrospinal fluid are
neurotoxic (lethargy, confusion, myoclonia,
convulsions). A sterile abscess can occur
at the area of the i.m. injection.

Hemolytic anemia, nephritis and liver
granuloma are very rare complications.
Massive i.v. doses are associated with a
risk of an electrolyte and volume overload.

penicillin causes more deaths than proheart [hurled epithet removed]

[name removed from an anonymous post]
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