FDA Drug Information That Never Reaches Clinicians

To the Editor: In their recent Perspective article (Oct. 29 issue), 1 Schwartz and Woloshin state that critical safety data were omitted from the first Zometa (zoledronic acid, Novartis) label, and they make several misleading statements that require clarification. Zometa was first approved for hypercalcemia of malignancy at a “maximum recommended” dose of 4 mg. 2 Although an 8-mg dose was tested in trials, clinical development of Zometa at this dose was discontinued when concerns arose about renal toxicity. The Food and Drug Administration (FDA) never approved the 8-mg dose. The authors incorrectly suggest that the first label's warnings about the 8-mg . . .