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Dear Healthcare Professional,
This letter describes important modifications to the Rezulin(R) prescribing information. These changes include the following:
Limitation on Use as Single Agent Therapy
Because of rare cases of severe hepatotoxicity that have occurred in patients treated with Rezulin, Parke-Davis and FDA agreed that Rezulin will no longer be indicated as initial single agent therapy in patients with type 2 diabetes mellitus. Despite the fact that Rezulin is no longer indicated for initial single agent therapy, you may consider it appropriate, based on your clinical judgment of the risk benefit profile in an individual patient, to continue Rezulin in some patients who are currently receiving Rezulin as single agent therapy. Such patients might include those who have been able to eliminate the need for insulin or sulfonylurea following addition of Rezulin or patients who have responded well to Rezulin single agent therapy, and who have tolerated the drug without any evidence of hepatotoxicity. In all such cases, the risk of hepatotoxicity that may be associated with continuation of Rezulin therapy in an individual patient should be weighed carefully against the expected benefits of continued therapy in that individual patient and the risk benefit profile of other available therapies.
Modification to the Liver Function Monitoring Schedule
The recommendations for monitoring of liver enzymes have been modified. Serum transaminase levels should be tested before starting therapy, then monthly during the first year of therapy (rather than the ten tests previously recommended). Thereafter, liver enzymes should be tested quarterly while on Rezulin therapy (rather than periodically as previously recommended).
New Patient Information Sheet
Within the next several weeks, Parke-Davis will publish a Patient Information Sheet that will be available for distribution by pharmacists to patients with each Rezulin prescription. The Patient Information Sheet has been approved by the FDA and will provide information on the safe and effective use of Rezulin. It will also remind patients of the importance of liver enzyme monitoring in accordance with the labeling. The revised prescribing information contains the full text of the Patient Information Sheet.
New Triple Therapy Indication
Despite the use of different combination therapies, many patients do not achieve adequate glycemic control. Rezulin has been shown to be effective in helping some patients to achieve glycemic control when used in combination with metformin and a sulfonylurea. Accordingly, the product labeling will be revised to add a new indication for use of Rezulin in combination with a sulfonylurea and metformin for patients who are not adequately controlled on a combination of the two agents.
Please see accompanying full prescribing information. Additional information on the risks and benefits of Rezulin is available from your Parke-Davis and Sankyo Parke Davis representatives and at our web site Rezulinnews.com.
Parke-Davis encourages healthcare providers to report any new cases of adverse events to Parke-Davis at 1-800-223-0432 or to the FDA MedWatch program at 1-800-FDA-1088, by fax at 1-800-FDA-0178, via the MedWatch website at www.fda.gov/medwatch, or by mail (using postage-paid form) at MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787.
Sincerely,
William R. Sigmund II, M.D., M.H.S., F.A.C.C.
Vice President, Medical and Scientific Affairs
Parke-Davis
201 Tabor Road
Morris Plains, NJ 07950
1-800-223-0432
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