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Injuries and Deaths Linked to Omontys

Thomas J. Henry is currently investigating the anemia drug Omontys (peginesatide). Omontys was recalled in February 2013 after reports of serious hypersensitivity reactions, some of which resulted in death after just one dose.


“Due to the severity of the public health risk, we want to be certain that healthcare providers stop using Omontys.” – Howard Sklamberg, FDA Center for Drug Evaluation and Research as published by Reuters.

  • Omontys is an injection used to treat anemia in adult dialysis patients.
  • It was approved by the U.S. Food and Drug Administration (FDA) in March, 2012.
  • Omontys is manufactured by the Takeda Pharmaceutical Company Ltd. and Affymax Inc.
  • According to news releases, the FDA alerted health care providers in February 2013 after receiving 19 reports from U.S. dialysis centers of serious allergic reactions requiring immediate medical attention.
  • Reports allege that at least three of these incidents resulted in death.
  • Takeda and Affymax responded by pulling the drug from the market on February 23, 2013.

Hypersensitivity occurs when the body’s immune system produces excessive and/or undesirable reactions. The hypersensitivity reported in connection to Omontys is classified as Type 1 (anaphylactic) hypersensitivity.  This means the onset is immediate and results in inflammatory reactions that can cause rash, shortness of breath, wheezing, and death.

OTHER ADVERSE EFFECTS LINKED TO OMONTYS provides a complete list of Omontys side effects. Click here to view.

  • Increased Risk of Heart Attack
  • Increased Risk of Stroke
  • Hypotension
  • Hypertension
  • Upper Respiratory Infection
  • Seizure
  • Anaphylaxis
  • Death


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