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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Enforcement Actions

Bayer Health Care LLC 03-Sep-08

Department of Health and Human Services' logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration

 

Rockville MD 20857


SEP 3 2008

WARNING LETTER

Certified Mail
Return Receipt Requested

NADA 141-007 (L0291)

Greg Babe
President and Chief Executive Officer
Bayer Corporation
Bayer HealthCare LLC, Animal Health Division
P.O. Box 390
Shawnee Mission, Kansas 66201

RE: Drontal® Plus (praziquantel/pyrantel pamoate/febantel) Tablets, Broad
Spectrum Anthelmintic for Dogs and Drontal® Plus Taste Tabs®, Broad Spectrum
Chewable Anthelmintic Tablets for Dogs Master Detailer

Dear Mr. Babe:

The Center for Veterinary Medicine (CVM) has reviewed a promotional piece (master detailer (D08181)) for Drontal® Plus (praziquantel/pyrantel pamoate/febantel) Tablets Broad Spectrum Anthelmintic for Dogs and Drontal® Plus Taste Tabs® Broad Spectrum Chewable Anthelmintic Tablets for Dogs, NADA 141-007, submitted by your firm as promotional material in a special Drug Experience Report (DER) submission on June 11, 2008. This master detailer contains suggestions, not approved or permitted for use in labeling, that Drontal® Plus Tablets Broad Spectrum Anthelmintic for Dogs and Drontal® Plus Taste Tabs® Broad Spectrum Chewable Anthelmintic Tablets for Dogs are more effective than has been demonstrated by substantial evidence or substantial clinical experience and thus misbrands these products within the meaning of section 502(n) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. 352(n)].

Background
Drontal® Plus Tablets Broad Spectrum Anthelmintic Tablets for Dogs and Drontal® Plus Taste Tabs® Broad Spectrum Chewable Anthelmintic Tablets for Dogs are oral tablet formulations containing praziquantel, pyrantel pamoate, and febantel. Both products are approved for the removal of tapeworms (Dipylidium caninum, Taenia pisiformis, Echinococcus granulosus, and removal and control of Echinococcus multiocularis) and for removal of hookworms (Ancylostoma caninum, Uncinaria stenocephala), ascarids (Toxocara canis, Toxacaris leonina), and whipworms (Trichuris vulpis) in dogs.

Unsubstantiated Claim of Effectiveness
The master detailer submitted in the DER states, "Over 13% of the United States population is infected with Toxocara, a parasite of dogs and cats that can be passed from animals to humans" and that, "A deworming program with Drontal® Plus Tablets or Drontal® Plus Taste Tabs® can help reduce the risk of parasitic zoonosis to your clients and staff." These statements suggest that Drontal® Plus Tablets and Drontal® Plus Taste Tabs® are effective for reducing the risk of parasitic zoonosis in humans when the products are not approved for this use. This suggestion has not been approved or permitted for use in the labeling of Drontal® Plus Tablets or Drontal® Plus Taste Tabs®. In addition, CVM is not aware of substantial evidence or substantial clinical experience to support the effectiveness of Drontal® Plus Tablets or Drontal® Plus Taste Tabs® for the prevention of toxocariasis or any other zoonotic disease in humans. The master detailer thus contains suggestions, not approved or permitted for use in the labeling, that Drontal® Plus Tablets and Drontal® Plus Taste Tabs® are more effective than has been demonstrated by substantial evidence or substantial clinical experience. Suggestions that the use of Drontal® Plus Tablets or Drontal® Plus Taste Tabs® in dogs reduces the risk of toxocariasis or any other zoonotic disease in humans is particularly troublesome because early diagnosis and treatment in humans may be delayed.

Conclusion and Requested Action
As described above, the master detailer (D08181) overstates the effectiveness of Drontal® Plus Tablets and Drontal® Plus Taste Tabs® in violation of 21 CFR 202.1(e)(6)(1). Accordingly, the drug praziquantel/pyrantel pamoate/febantel is deemed to be misbranded within the meaning of section 502(n) of the Act [21 U.S.C. 352(n)].

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 Drontal® Plus Tablets and Drontal® Plus Taste Tabs®, 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 promotional material for Drontal® Plus Tablets and Drontal® Plus Taste Tabs® such as those described above. Specifically, you should cease the dissemination of the master detailer for Drontal® Plus Tablets and Drontal® Plus Taste Tabs® and any other materials that may contain similar information. Future advertisements and promotional materials should adequately address the claims for the prevention and treatment of the appropriate 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, PhD, DABVT
Director, Division of Surveillance
HFV-210
Center for Veterinary Medicine

cc:
Jan Cunningham
Director, US Regulatory Affairs
Bayer HealthCare LLC, Animal Health Division
P.O. Box 390
Shawnee Mission, Kansas 66201