Ortho modifies Procrit Rxing info

Ortho Biotech Products, a Johnson & Johnson company, has modified prescribing information for Procrit (epoetin alfa), following guidance from the US Food and Drug Administration to revise labeling for all drugs within the erythropoiesis-stimulating agent class.

The firm says that modifications to the label were based on an unplanned interim analysis of IS biotechnology major Amgen's PREPARE study in women with breast cancer receiving preoperative chemotherapy, and from GOG-191, a study of advanced cervical cancer patients conducted by the Gynecologic Oncology Group with support from Ortho Biotech (Marketletters passim). Both investigational studies were designed to evaluate the efficacy of maintaining hemoglobin levels greater than 12g per deciliter of blood (g/dL) and observed lower survival in patients being treated with ESAs. However, neither study showed a statistically-significant effect on survival or tumor outcomes.

The Boxed Warnings have been modified to now read: "Warnings; increased mortality, serious cardiovascular and thromboembolic events and tumor progression."