FDA Warns Of Omontys Injection Health Risks; Recall Issued

Posted on February 25, 2013

The Food and Drug Administration is warning consumers and healthcare professionals of the dangers posed by a drug meant to treat anemia in those adult persons going through dialysis.  If you fall into this category, then it’s imperative that you read on to learn more about the hazard posed by the drug.

The recall being issued concerns Omontys Injection.  The Deerfield, Illinois-based Takeda Pharmaceuticals and the Palo Alto, California-based Affymax are responsible for the distribution of the drug, and the former is who consumers should send the item back to.

Dialysis centers across the country have reported 19 incidents of anaphylaxis to the FDA.  The companies explain that these serious hypersensitivity issues take place within a half hour of a person receiving Omontys intravenously.  In some of the reported cases, immediate hospitalization and the assistance of medical officials was required, and resuscitation even had to be carried out in a few instances.  However, three persons still died after experiencing this anaphylaxis.

The serious threat has prompted the FDA to caution all medical facilities against using the drug, which was only approved this past March.  The FDA has vowed to conduct an investigation into the drug and the facilities in which it was made and processed.  Anyone who suffers from these severe side effects should consult a doctor immediately and then report the incident to MedWatch.

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