ParagonRx® | Minimize Risk and Optimize Use

Add three more drugs whose commercial availability is contingent on a risk evaluation and mitigation strategy: Aranesp, Epogen and Procrit. All three are erythropoiesis-stimulating agents (ESAs) made by Amgen and Centocor Ortho Biotech Products. We reported earlier this week that Auxilium's just-approved biologic for a progressive hand disease also requires one.

The FDA says ESAs can increase the risk of tumor growth and shorten survival in patients with cancer. They can also increase the risk of heart attack, heart failure, stroke or blood clots in those using the drugs to treat other conditions. [Full Story]