FDA Strengthens Warning Label on Feraheme
The U.S. Food and Drug Administration (FDA) is strengthening an existing warning on the anemia drug Feraheme (ferumoxytol) to reduce the risk of serious, potentially fatal allergic reactions. According to an FDA Safety Announcement dated March 30th, the agency has approved a boxed warning, which is the most serious type of warning, … [Read more...] about FDA Strengthens Warning Label on Feraheme
CellCept Anemia Risk
CellCept Associated with Anemia CellCept has been associated with a severe type of anemia, the Food & Drug Administration (FDA) warned today. CellCept's label has been revised to warn doctors about the condition, called pure red cell aplasia (PRCA). CellCept—generically known as mycophenolate mofetil—is part of a class of … [Read more...] about CellCept Anemia Risk
Aranesp Black Box Warning
Aranesp, Epogen, Procrit Black Box Warning. Aranesp, Epogen and Procrit, drugs used to treat anemia in patients undergoing chemotherapy, will soon bear new black box warnings that they may shorten survival time in patients with certain types of tumors. Amgen's Aranesp and Epogen, and Johnson & Johnson's Procrit, have … [Read more...] about Aranesp Black Box Warning
FDA panel wants more anemia drug studies
Two months after federal regulators ordered additional warnings be added to the labels of blockbuster anemia drugs, government advisers said Thursday Amgen Inc. and Johnson & Johnson should be required to add more warnings and conduct additional safety studies. The Food and Drug Administration's outside panel of experts voted … [Read more...] about FDA panel wants more anemia drug studies
Raptiva Label to Include Hemolytic Anemia Warning
Raptiva May Cause Hemolytic Anemia. The FDA announced today new warnings on the Genentech psoriasis drug Raptiva (efalizumab) following reports of four cases of hemolytic anemia diagnosed four to six months after patients started on the monoclonal antibody. Two of the cases occurred in clinical trials of Raptiva, and two … [Read more...] about Raptiva Label to Include Hemolytic Anemia Warning
