Released by FDA: 10/11/00.  Posted by FDA:  10/17/00

Nanette E. Holston 
Manager, U.S. Regulatory Affairs 
Wyeth-Ayerst 
P.O. Box 8299 
Philadelphia, PA 19101-8299

RE:   NDA#20-699 
        Effexor XR (venlafaxine) Extended Release Capsules 
        MACMIS #8741

Dear Ms. Holston:

Through routine monitoring and surveillance, the Division of Drug Marketing, Advertising, and Communications (DDMAC) has become aware of a promotional campaign for Effexor XR (venlafaxine) Extended Release Capsules that is false, misleading, or otherwise in violation of the Federal Food, Drug, and Cosmetic Act and its regulations.  Promotional materials that comprise this campaign include, but are not limited to, journal advertisements (ID#s 79347-00, 79396-00), sales aids, (ID#s 79368-00, 79457-00), mailers (lD#s 79524-00, 79364-00, 79520-00, 79521-00) and brochures (lD#s 79366-00, 79349-00, 79539-00).

More specifically, these materials are misleading because they directly claim or imply that Effexor XR can get patients “beyond better to well” and can “bring patients to true weliness.”  “Well” is a broad category that implies a cure or freedom from a disease or illness, not simply that its symptoms are alleviated.  Control of one’s disease or condition does not necessarily make one “well.”  “Beyond better” and “true wellness” implies the ultimate response that anyone who had the condition has been cured and is no different than a person who never had the condition.  These claims further imply that it will be unlikely that the condition will return.  DDMAC has reviewed Wyeth-Ayerst’s (Wyeth) data to support these claims.  The data fail to demonstrate that Effexor has cured depression (i.e., after treatment with Effexor, drug therapy can be terminated and depression will no longer occur).  In addition, the data fail to demonstrate that Effexor has caused a “remission” of depression.  Therefore, DDMAC has determined that there is no adequate substantiation for the claims in question.

In addition to the issues described above, the promotional materials that depict children are misleading because the disclaimer that the efficacy and safety of Effexor XR for pediatric use has not been established is not prominent.

To address these objections, DDMAC recommends that Wyeth do the following:

1. Immediately discontinue the use of these materials and any other promotional materials with the same or similar issues.
   
   
2. Respond to this letter, in writing, within 10 days.  Wyeth-Ayerst’s response should include a statement of its intent to comply with the above, a list of all violative promotional materials with the same or similar issues, and Wyeth’s methods for discontinuing the materials.

In all future correspondence regarding this particular matter, please refer to MACMIS ID # 8741 in addition to the NDA number.

If you have any questions or comments, please contact Dr. Lisa L. Stockbridge by facsimile at (301) 594-6771, or at the Food and Drug Administration, Division of Drug Marketing, Advertising and Communications, HFD-42, rm. 17B-20, 5600 Fishers Lane, Rockville, MD 20857.  DDMAC reminds you that only written communications are considered official.

Sincerely,

Lisa L. Stockbridge, Ph.D. 
Regulatory Review Officer 
Division of Drug Marketing, 
    Advertising and Communications