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# FDA Airs Daprodustat Safety Concerns
- URL: https://www.fdaweb.com/fda-airs-daprodustat-safety-concerns/
- Published: 2022-10-25T12:00:00.000Z
- Updated: 2026-09-14T18:04:06.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5153051

In advance of a 10/26 meeting of the FDA Cardiovascular and Renal Drugs Advisory Committee meeting to consider GlaxoSmithKline’s anemia drug daprodustat, FDA medical reviewers are raising safety concerns about the drug. The company is seeking an indication to treat anemia due to chronic kidney disease in adult patients on dialysis and not on dialysis.

In a [briefing document](https://www.fda.gov/media/162521/download?ref=fdaweb.com), the medical reviewers say the drug’s efficacy in raising hemoglobin levels is not in question. However, they raise safety issues both in patients on dialysis and not on dialysis.

In the dialysis-dependent group in clinical trials, the paper says, risks included hospitalization for heart failure and bleeding gastric erosions. In the non-dialysis-dependent patients, it appeared to have several additional risks, including elevated estimated risks for heart attack and stroke, and other potential issues.

The briefing paper has points for the advisory committee to consider and discuss for both patient groups in determining whether the drug’s benefits outweigh its risks.