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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Rabies Immune Globulin (Human), Imogam Rabies-HT and Rabies Vaccine, Imovax Rabies

February 24, 2004

VIA FASCIMILE AND CERTIFIED MAIL
RETURN RECEIPT REQUESTED

Luc Kuykens, MD, MPH, DTM
Vice President, Regulatory Affairs
North America
Aventis Pasteur Inc.
Discover Drive
Swiftwater, PA 18370

Re: BLA STN #103932 / 103931

Imogam Rabies-HT [Rabies Immune Globulin (Human) USP, Heat Treated] and
Imovax Rabies [Rabies Vaccine]

Dear Dr. Kuykens:

The Advertising and Promotional Labeling Branch (APLB) in the Food and Drug Administration's Center for Biologics Evaluation and Research (CBER) has identified a rabies poster (MKT7840-2), for Imogam Rabies-HT [Rabies Immune Globulin (Human) USP, Heat Treated] and Imovax Rabies [Rabies Vaccine]. The poster is false or misleading under section 502(a) of the Federal Food, Drug, and Cosmetic Act (the Act) (21 U.S.C. §352(a)) because it omits important risk information and contains a false or misleading statement.

Background

Imogam is a sterile solution of antirabies immunoglobulin for intramuscular administration. According to the approved labeling (PI), Imogam is indicated for individuals suspected of exposure to rabies.

Imovax is a freeze-dried suspension of rabies virus prepared from strain PM 1503-3M. According to the PI, Imovax is indicated for possible rabies exposure, and for pre-and post-exposure treatment of rabies.

Omission of Important Risk Information

The poster shows a raccoon and bears the caption "Rabies is on the Prowl." It contains statements identifying a number of people as being at risk for rabies and the statement: "If left untreated, rabies is almost always fatal." The poster bears the proprietary and established names of Imogam and Imovax.

The poster contains no risk information for either product. The PI for Imogam contains a warning that Imogam is made from human plasma and may carry a risk of transmitting infectious agents. In addition, Imogam is associated with systemic adverse reactions, such as headache and malaise, and local adverse reactions, such as pain and tenderness at the injection site. Imovax is associated with headache, nausea, abdominal pain, muscle aches, and dizziness, and also presents risks of pain, erythema, and swelling or itching at the injection site with Imovax. The poster thus minimizes the risks of Imogam and Imovax and misleadingly suggests that these drugs are safer than has been demonstrated by substantial evidence or substantial clinical experience.

False or Misleading Statement

The poster states, "Your single source for rabies protection." This implies that no other manufacturers supply products that protect against rabies.

Your statement is false or misleading because there are other sources for rabies protection. For example, Chiron Behring makes RabAvert, a rabies vaccine indicated for pre- exposure immunization and for post-exposure prophylaxis against rabies. Bayer Corporation makes BayRab, Rabies Immune Globulin (Human), which is indicated for use with rabies vaccine for post-exposure protection (except for previously-vaccinated individuals).

Conclusion and Requested Actions

The poster misbrands Imogam and Imovax within the meaning of section 502(a) of the Act (21 U.S.C. §352(a)) because it represents that Imogam and Imovax are safer than has been demonstrated by substantial evidence or substantial clinical experience, and because it contains a false or misleading statement.

APLB requests that Aventis Pasteur immediately cease disseminating promotional materials for Imogam and Imovax that contain claims the same as, or similar to, those described above. Please submit a written response to this letter within 10 business days of the date of this letter, describing your intent to comply with this request, listing all promotional materials for Imogam and Imovax that contain claims the same as or similar to those described above, and explaining your plan for discontinuing use of such materials.

Please direct your response to Mr. Glenn N. Byrd, Chief, APLB, at the following address:

Center for Biologics Evaluation and Research
Office of Compliance and Biologics Quality
Division of Case Management
Advertising and Promotional Labeling Branch, HFM-602
1401 Rockville Pike
Rockville, MD 20852-1448.

In all future correspondence regarding this matter, please refer to the BLA number. We remind you that only written communications are considered official. Should you have any questions or concerns involving this matter, please contact CDR Nancy Chamberlin, Regulatory Review Officer at 301-827-3028.

This letter is not intended to be an all-inclusive list of deficiencies associated with your promotion of the above product. It is your responsibility to ensure that all materials distributed within the United States comply with each applicable requirement of the Act and FDA regulations. If you choose to revise your promotional materials, APLB is willing to assist you in assuring that your revised materials comply with applicable provisions of the Act by reviewing your revisions before you use them in promotion.

Sincerely,

----- signature -----

Mary A. Malarkey, Director
Division of Case Management
Office of Compliance and Biologics Quality
Center for Biologics Evaluation and Research

Enclosure