Released by FDA: 6/28/01.  Posted by FDA:  7/31/01

Sharon W. Shapowal, R.Ph. 
Director, Avandia
U.S. Regulatory Affairs 
GlaxoSmithKline
One Franklin Plaza 
PO Box 7929 
Philadelphia, PA 19101

RE:   Avandia® (rosiglitazone maleate) Tablets 
         NDA 21-071
         MACMIS ID#10171

Dear Ms. Shapowal:

This letter objects to GlaxoSmithKline's (GSK) dissemination of violative promotional materials for Avandia (rosiglitazone maleate) tablets.  As part of its monitoring program, the Division of Drug Marketing, Advertising and Communications (DDMAC) has become aware of direct-to-consumer (DTC) broadcast and print advertisements for Avandia that are false or misleading, in violation of the Federal Food, Drug, and Cosmetic Act (Act) and its implementing regulations.  The DTC broadcast ("Real Stories") and print (AV8580B and AV9117) advertisements submitted on Form FDA 2253, are violative for the reasons described below.

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Avandia's approved product labeling (PI) includes a bolded warning that "The use of Avandia (rosiglitazone maleate) in combination therapy with insulin is not indicated."   You present the statement "Avandia is not indicated for use with insulin" in the audio portion of your "Real Stories" broadcast advertisement simultaneously with the super "Avandia-Help use the natural insulin in you."   This presentation minimizes the communication of the risk of the Bolded Warning by presenting consumers with conflicting messages about the use of Avandia and insulin.   Moreover, your statement "Avandia is not indicated for use with insulin" also minimizes the bolded warning because it is not in consumer-friendly language and therefore unlikely to be understood by consumers.   In addition, your broadcast advertisement is misleading because you fail to present the precaution from your PI concerning weight gain caused by Avandia.

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Similarly, the statements in your print advertisements (AV8580B and AV9117) that "In some people, Avandia may cause fluid retention, or swelling.   This could lead to or worsen congestive heart failure, particularly in people taking insulin, so tell your doctor if you have a history of these conditions." are misleading because they minimize the Bolded Warning.

Moreover, your print advertisement is misleading because the risk information is presented under the header "Strengthen your body's own ability to help control blood sugar."   This presentation of the risk information under such a header relating to Avandia's efficacy minimizes the risks associated with Avandia treatment.

Requested Action

GSK should immediately discontinue these and all other promotional materials and activities for Avandia that contain the same or similar claims or presentations.   We request that GSK respond, in writing, with its intent to comply with the above. DDMAC should receive your written response no later than July 13, 2001.  This response should list similarly violative materials with a description of the method for discontinuation and the discontinuation date.

If you have any questions or comments, please contact me 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.

In all future correspondence regarding this particular matter, please refer to MACMIS ID #10171 in addition to the NDA number.

Sincerely,

 

Barbara S. Chong, Pharm.D., BCPS 
Regulatory Review Officer 
Division of Drug Marketing, 
   Advertising and Communications