June A Busy Month For FDA Veterinary Warnings

Heartgard boxes

Over the last 12 months, the FDA’s Center for Veterinary Medicine has issued a total of 5 warning letters to pet drug manufacturers. Four of the five were issued in June — almost a fifth of all FDA warning letters for that month.

We notified you of the Bayer flea medication warning yesterday. Today, we’ll provide you with a summary of the other three warnings, including a repeat violation by the makers of the Tri-Heart Plus brand and Heartgard brand. Both brands have been flagged by the FDA for misleading statements.

Itchmo will continue to report on any new FDA warning on veterinary products. To stay informed, sign up for our safety alerts.

PS. Here’s yet another veterinary drug warning, this time on the Reconcile separation anxiety drug.

Heartgard warning summary

Merial, makers of Heartgard — a popular brand of heartworm prevention medication — has been warned twice in the last 12 months. The warning are similar to others and blame overzealous marketing and claims. Their latest warning in June is due to Heartgard claiming zoonosis control (zoonosis is any infectious disease that is transmitted from other animals to humans or from humans to animals). The FDA says there is insufficient evidence to claim that Heartgard will prevent transmission of warms from pets to humans.

Full warning letter is posted below.

Tri-Heart Pro warning summary

Heska and Schering-Plough Animal Health corporations, makers of the Tri-Heart Plus brand heartworm medication, was found in violation of FDA regulations for implying a guarantee and protection against whipworms. The violation was recorded in March of 2007, and the companies agreed to correct the language. However, the problem guarantee continued to persist, resulting in a warning letter in June.

As of this reporting, the whipworm references on their website have been removed. Full warning letter is posted below.

Heartgard warning

JUN 21 2002

WARNING LETTER

NWE-19-07W

Certified Mail
Return Receipt Requested

NADA 140-971 (L1328)

Liubov Skibo
Director, Regulatory Affairs
Merial Limited
3239 Satellite Boulevard
Duluth, GA 30096
RE: Heartgard® Plus (ivermectin/pyrantel) advertisement in the Journal of the American Veterinary Medical Association (4/1/07 & 4/15107 issues)

Dear Ms. Skibo:

We, the Division of Surveillance (DOS), Center for Veterinary Medicine, have reviewed your advertisement entitled “Unmatched” in the Journal of American Veterinary Medical Association (JAVMA) for Heartgard® Plus (ivermectin/pyrantel) Chewables for Dogs, NADA 140-971. This advertisement appeared in the April 1 and 15, 2007, JAVMA issues. This advertisement causes Heartgard® Plus to be misbranded within the meaning of section 502(n) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. 352(n)].

Background

Heartgard® Plus is an oral chewable formulation containing ivermectin and pyrantel. It is approved for the prevention of canine heartworm disease by eliminating the tissue stage of heartworm larvae (Diroflaria immitis) for a month (30 days) after infection and for the treatment and control of ascarids (Toxocara canis, Toxocaris leonina) and hookworms (Ancylostoma caninum, Uncinaria stenocephala, Ancylostoma brazillense). It is approved to be administered orally at monthly intervals

Unsubstantiated Claims of Effectiveness

The advertisement in JAVMA makes the claims “Heartworm and zoonosis control in a Real-Beef Chewable” and “Heartgard® Plus harnesses the irresistible power of real beef to make sure dogs get a full dose of heartworm prevention and zoonotic disease treatment and control.” These statements imply the drug is effective for controlling and treating zoonotic diseases generally, not only ascarids and hookworms. These statements thus overstate the demonstrated effectiveness of Heartgard® Plus. CVM is not aware of substantial evidence to support this broad range of conditions. If you have supporting data, please submit it to FDA for review. While we acknowledge that the advertisement also states that the drug provides “Both treatment and control of the most common zoonotic intestinal parasites,” which would include ascarids and hookworms, this is presented in significantly smaller print than the other two statements and is insufficient to correct the overall misleading impression created by the piece.

In addition, the advertisement includes a testimonial that implies use of the drug in dogs will prevent the zoonotic transmission of toxocariasis and subsequent ocular larval migrans in humans. The statements described in the previous paragraph are on a page showing a picture of a dog being given what appears to be Heartgard® Plus. The dog is linked by its leash to a photo on the opposite page that shows a woman and a child in a public park. Above the photo is the headline, “Never turn a blind eye to the threat of zoonotic disease.” The accompanying text details a mother’s testimonial of her four year old son who contracted toxocariasis and subsequent unilateral blindness due to ocular larval migrans. The testimonial includes statements linking the prevention of roundworms in dogs to the prevention of transmission to humans, such as:

“Before Christopher’s infection we’d heard of roundworms - and we knew that they could be transmitted to people. . . . I urge you, as veterinary professional, to tell pet owners about the risks of these diseases and how to avoid transmission. Talk to them about preventing roundworms and hookworms. “

The overall impression is that the use of Heartgard® Plus in dogs will prevent zoonotic transmission of toxocariasis and subsequent ocular larval migrans in humans. CVM is not aware of substantial evidence or substantial clinical experience to support the effectiveness of Heartgard® Plus for the prevention of toxocariasis, ocular larval migrans, or any other zoonotic disease in humans. Suggestions that the use of Heartgard® Plus in dogs prevents toxocariasis, ocular larval migrans, or any other zoonotic disease in humans, especially in children, is particularly troublesome because early diagnosis and treatment in humans may be delayed.

Conclusion and Requested Action

The advertisement described above overstates the effectiveness of Heartgard® Plus. Accordingly, the drug is misbranded within the meaning of section 502(n) of the Act [21 U.S.C. 352(n)] and FDA implementing regulations at 21 CFR 202.1 (e)(6)(i).

The violations discussed in this letter do not necessarily constitute an exhaustive list. It is your responsibility to ensure that your advertisements and promotional materials for Heartgard® Plus, as well as for your other products, comply with the requirements of the Act and its implementing regulations. Failure to correct the violations discussed above may result in FDA regulatory action without further notice such as seizure and/or injunction.

You should notify this office in writing within fifteen (15) working days of receiving this letter of the steps you have taken to bring your firm into compliance with the law. Your response should include each step that has been taken or will be taken to correct the violations and prevent their recurrence. If corrective action cannot be completed within fifteen (15) working days, state the reason for the delay and the time frame within which the corrections will be completed. Please include copies of any available documentation demonstrating that corrections have been made.

In addition, we request that you immediately cease the dissemination of violative advertisements for Heartgard0 Plus such as those described above. Specifically, you should cease the dissemination of the advertisements in the Journal of the American Veterinary Medical Association concerning Heartgard® Plus and any other materials that may contain similar information. Future advertisements and promotional materials should adequately address the claims for the prevention of heartworm and other intestinal parasites, described in the currently approved labeling, without overstating the effectiveness. Because the violations described above are serious, we request that your submission include a comprehensive plan of action to disseminate a truthful, non-misleading, and complete corrective message about the issues discussed in this letter to the audience(s) that received the violative advertisements.

Please send your written reply to the Food and Drug Administration, Attention: Lynn O. Post, 7519 Standish Place, Rockville, MD 20855. If you have questions regarding any issue in this letter, please contact Lynn O. Post at (240) 276-9062.

Sincerely yours,

/s/

Lynn O.Post, DVM, Ph.D. DABVT
Director, Division of Surveillance
HFV-210
Center for Veterinary Medicine

Tri-Heart Pro warning

JUN 5 2007
WARNING LETTER

Certified Mail
Return Receipt Requested

ANADA 200-338 (L-0177)

Marilyn M. Porter, DVM
Regulatory Affairs Associate/Animal Testing
Heska Corporation
2538 SE 43rd Street
Des Moines, Iowa 50327

Nancy Thompson-Brown
Senior Regulatory Compliance Specialist
Schering-Plough Animal Health Corporation
1095 Morris Avenue
Union, NJ 07083-1982

RE: ANADA 200-338 Tri-Heart® Plus (ivermectin/pyrantel); product web site: http://www.triheartplus.com/satisfaction_guaranteed.html;
http://www.triheartplus.com/parasites.html

Dear Dr. Porter and Ms. Thompson-Brown:

We, the Division of Surveillance (DOS), Center for Veterinary Medicine, have reviewed your web site for Tri-Heart® Plus (ivermectin/pyrantel), ANADA 200-338. This promotional piece is misleading because it presents an unsubstantiated claim regarding Tri-Heart Plus, misbranding the drug under sections 502(n) and 201(n) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. 352(n) and 321(n)) and FDA implementing regulations, 21 CFR 202.1(e)(6)(i).

Background

Tri-Heart® Plus is an oral antiparasitic medication for use in dogs indicated for prevention of heartworm disease by eliminating the tissue stage of heartworm larvae (Dirofilarfa immitis) for a month (30 days) after infection and for the treatment and control of ascarids (Toxocara canis, Toxocara leonina) and hookworms (Ancylostoma caninum, Uncinaria stenocephala, Ancylostoma braziliense).

On March 6, 2007, CVM sent an untitled letter to you objecting to promotional labeling piece spah-thp-27R2. The promotional labeling piece in question was a mailer entitled “The most Comprehensive Guarantee in Heartworm Prevention” which included a guarantee relating to whipworms. Schering-Plough Animal Health responded by letter dated April 6, 2007, agreeing that the claims presented in the piece were overstated, and agreeing to immediately cease dissemination of the piece and any others with the same language. The April 6, 2007, response letter stated that future promotions will read, “Tri-Heart® Plus is not approved or effective for removal or control of whipworms, but if you prescribe Tri-Heart® Plus to a whipworm negative dog and the animal is diagnosed with whipworms within the Tri-Heart® Plus use period, our guarantee will cover the cost of a remedial treatment.”

Unsubstantiated Claim of Effectiveness

As of the date of this letter, your web site page entitled “About Tri-Heart® Plus-100% Satisfaction Guaranteed” contains the following statement: “Our Guarantee Covers . . .Tri-Heart® Plus is not registered for removal and control of whipworms, but if you prescribe Tri-Heart® Plus to a whipworm negative dog and the animal is diagnosed with whipworms within the Tri-Heart® Plus use period, our guarantee will cover the cost of a remedial treatment.” Despite your agreement to immediately cease dissemination of the mailer piece spah-thp-27R piece and any others with the same language, your web site continues to include the exact statement we objected to in our letter dated March 6, 2007.

Additionally, the web page entitled “Heartworm and Other Parasites” states “Many heartworm preventive medicines for pets do eliminate other parasites such as hookworms, whipworms and roundworms . . .” The page then offers a description of hookworm, roundworm, and whipworm infections in dogs. These statements suggest Tri-Heart® Plus is among the referenced heartworm preventative products that are effective for the prevention, removal and/or control of whipworms. These indications, however, are not permitted under the product’s approved labeling and CVM is not aware of substantial evidence to support a claim of effectiveness against whipworms for your product. If you have supporting data, please submit it to FDA for review.

In addition, the suggested revised statement in your April 6, 2007, letter continues to imply effectiveness of Tri-Heart® Plus for the prevention of whipworms. Despite the disclaimer that the product is not approved or effective for removal and control of whipworms, the guarantee still suggests that Tri-Heart® Plus is effective for the prevention of whipworms. The statement thus continues to be misleading by overstating the product’s demonstrated effectiveness.

Conclusion and Requested Action

The violations discussed in this letter do not necessarily constitute an exhaustive list. It is your responsibility to ensure that your promotional materials for Tri-Heart® Plus, as well as for your other products, comply with the requirements of the Act and its implementing regulations. Failure to correct the violations discussed above may result in FDA regulatory action without further notice such as seizure and/or injunction.

You should notify this office in writing of the steps you have taken-to bring your firm into compliance with the law within fifteen (15) working days of receiving this letter. Your response should include each step that has been taken or will be taken to correct the violations and prevent their recurrence. If corrective action cannot be completed within fifteen (15) working days, state the reason for the delay and the time frame within which the corrections will be completed. Please include copies of any available documentation demonstrating that corrections have been made.

In addition, we request that you immediately cease the dissemination of violative promotional materials for Tri-Heart® Plus such as those described above. Specifically, you should correct the promotional materials on your web site concerning Tri-Heart® Plus and any other materials that may contain similar information. Future promotional materials should adequately address the claims of heartworm and other intestinal parasite prevention, described in the currently approved labeling, without overstating the effectiveness. Because the violations described above are serious, we request that your submission include a comprehensive plan of action to disseminate a truthful, non-misleading, and complete corrective message about the issues discussed in this letter to the audience(s) that received the violative promotional materials.

Please send your written reply to the Food and Drug Administration, Attention: Martine Hartogensis, 7519 Standish Place, Rockville, MD 20855. If you have questions: Martine regarding any issue in this letter, you may contact us at (240) 276-9064.

Sincerely yours

/S/

Lynn O. Post, DVM, PhD, DABVT
Director, Division of Surveillance
HFV-210
Center for Veterinary Medicine

Table of FDA veterinary warning letters in the last 12 months

Company Name Date Warning Letter Issued Issuing Office Subject File
Bayer Health Care LLC
6/11/07
Center for Veterinary Medicine Promotional Claims/False & Misleading/Misbranded [PDF]
[HTML]
Elanco Animal Health
6/26/07
Center for Veterinary Medicine Veterinary Medicine [PDF]
[HTML]
Heska Corporation
6/05/07
Center for Veterinary Medicine Promotional Claims False & Misleading/Misbranded [PDF]
[HTML]
Merial Limited
6/21/07
Center for Veterinary Medicine Promotional Claims/New Drug/Misbranded [PDF]
[HTML]
Merial Limited
8/14/06
Center for Veterinary Medicine Promotional Claims/False & Misleading [PDF]
[HTML]

4 Responses to “June A Busy Month For FDA Veterinary Warnings”

  1. Roberto P. says:

    Sounds just like the pet food companies. They claim bird beaks, cow crap, carcinogenic additives are healthy for our pets. Vet meds are also making outlandish claims.

  2. Katie says:

    Itchmo, thank you for keeping us informed.

    Katie

  3. Tealcsmommy says:

    My vet encouraged me to give this to my chihuahua. When I did, he had a reaction to it that he has never had except when I tried the Frontline. He sort of heaved or something like that. Of course I stopped it and washed the Frontline off of him. I try everything else on him that is not a pesticide such as essential oils, homemade lemon spray, apple cidar vinegar, diotomaceous earth, neem oil, and on and on.

  4. loves cats says:

    please stop using essential oils on your precious doggie. They can be as bad as the Frontline!!!! Find a vet who practices western medicine in your area and she will help you with this……..


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