Fda Eyes Anemia Drugs' Blight Accident Afresh
The FDA today appear that it's reviewing added abstracts on cancer risks angry to the anemia drugs Aranesp, Epogen, and Procrit.
Those drugs are erythropoiesis-stimulating agents (ESAs). They boost production of red claret beef and already bear a "black box warning" (the FDA's toughest warning) about blight risk.
That warning, launched in March 2007 and revised in November 2007, is based on six studies. Now, the FDA is reviewing two more studies from Amgen, the aggregation that makes all three ESAs.
An FDA advising board will altercate the abstracts and revisit the drugs' risks and allowances in the next few months.
Meanwhile, the FDA advises doctors and patients to analysis and altercate the risks and allowances of ESAs categorical in the artefact label.
The new studies accommodate "further evidence" of the drugs' risks, states an FDA account release.
The FDA addendum that together, all eight studies (including the two new studies) appearance that tumors grew faster and adaptation ante were worse among patients with breast, non-small-cell lung, arch and neck, lymphoid, or cervical cancers who took ESAs compared with those who weren't demography those drugs.
An FDA advising board will altercate the abstracts and revisit the drugs' risks and allowances in the next few months.
Amgen provided the two new studies to the FDA in backward November and early December 2007, according to the FDA. While Amgen makes all three ESAs, Procrit is marketed and broadcast by Ortho Biotech LP, a accessory of Johnson & Johnson.