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U.S. Department of Health and Human Services

Safety

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Herceptin (trastuzumab) May 2000

Follow-up to May letter. Changes to BOXED WARNINGS, WARNINGS, and ADVERSE REACTIONS sections.

[October 6, 2000 - Letter - Genentech, Inc.]


Health professionals are notified of 62 postmarketing reports of serious adverse events related to the use of Herceptin. The serious adverse events are characterized by one or more of the following categories: hypersensitivity reactions, infusion reactions, and pulmonary reactions. Fifteen (15) patients died and nine (9) of these patients had onset of symptoms within 24 hours of infusion.

[May 3, 2000 - Letter - Genentech, Inc.]