Canadian review of Upjohn’s Depo-Provera
Executive Summary
On June 7, Upjohn will appeal Canadian Health Protection Branch's decision not to approve the application for Depo- Provera's use as a contraceptive until HPB's concerns about the drug's long-term safety are satisfied. In December, Canada issued a "notice of noncompliance" because it wants further information on the slight increase in risk of breast cancer in women under 35 that was seen in WHO's study of Depo-Provera. WHO said the risk was similar to that of oral contraceptives. HPB also wants more information on a decrease in bone density seen in a small study. To start the appeal, Upjohn will submit answers to these questions to the HPB. The Depo-Provera submission has been pending since 1983.