September 2002

Jane S. Ricciuti, RPh, MS

September 20, 2002

Introduction

Medscape's "Food and Drug Administration Approvals" column begins this month. It will post as a regular monthly column covering recent FDA drug and biological product approvals and significant product labeling changes.

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Cite this: September 2002 - Medscape - Sep 01, 2002.

Table 1. Number (%) of patients with Prespecified Adverse Events in ATAC Trial
Adverse Reaction	Arimidex n = 3092 (%)	Tamoxifen n = 3093 (%)
All Fractures	224 (7)	145 (5)
Fractures of spine, hip, wrist	89 (3)	62 (2)
Musculoskeletal disorders^*	940 (30)	737 (24)
Ischemic cardiovascular disease	92 (3)	74 (2)
Asthenia	513 (17)	491 (16)
Nausea and vomiting	348 (11)	342 (11)
Mood disturbances	521 (17)	511 (17)
Cataracts	128 (4)	140 (5)
Hot flashes	1082 (35)	1246 (40)
Deep venous thromboembolic events	40 (1)	60 (2)
Venous thromboembolic events	73 (2)	120(4)
Ischemic cerebrovascular events	40 (1)	74 (2)
Vaginal bleeding	147 (5)	270 (9)
Vaginal discharge	94 (3)	378 (12)
Endometrial cancer	3 (0.1)	15 (0.5)

^*Refers to joint symptoms, including arthritis, arthrosis, and arthralgia.

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September 2002

Introduction

Tables

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Authors and Disclosures

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