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. 2020 Jun 25;15(6):e0234541. doi: 10.1371/journal.pone.0234541

Table 1. Chronicle of regulatory actions and safety information related to ESAs.

1989–2002 2003–2006 2007 2010 2017
In 1989, Epogen (epoetin) was approved by the FDA for anemic renal failure patients. In 1993, Procrit (epoetin) was approved for anemic cancer under chemotherapy patients. In 2002, Aranesp (darbepoetin) was approved for both anemic renal failure and anemic cancer patients under chemotherapy. A majority of evidence from RCTs on increased risks of tumor progression, blood clotting, stroke, heart attacks, and/or mortality associated with the use of ESAs began to emerge. In March, the FDA issued a black box warning on ESAs used for renal failure and some types of cancer. Immediately thereafter, CMS issued new coverage and reimbursement policies for ESAs. In March, the FDA issued the ESA REMS for cancer patients with concomitant chemotherapy, mandating medication guides, communication plans, elements to assure safe use, and a monitoring plan. In April, the FDA removed ESA from the REMS program, citing manufacturer data and additional FDA analyses showing appropriate use of ESAs.