By Sarah Mirando  |  April 1, 2013

Category: Pharmaceuticals
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Anemia Drug Recalled Over Fatal Reactions

By Scott Ringwelski

 

Omontys anemia drug recallLess than a year after the new anemia drug Omontys (peginesatide) came to market it is in full recall due to reports of fatal hypersensitivity reactions, including anaphylaxis.  

Anaphylaxis is a serious allergic reaction that can occur rapidly and may cause death. Victims of Omontys allergic reactions reported suffering symptoms within 30 minutes of receiving their initial dose of the drug. Symptoms of anaphylaxis include an itchy rash, swollen throat and eyes, and low blood pressure.

In February 2013, the two companies behind Omontys, Takeda and Affymax, issued a statement on the Omontys recall that said approximately 0.02% of the 25,000 who had received the anemia drug after approval had died from anaphylactic reactions. The rate of overall hypersensitivity reactions reported was 0.2% with approximately a third of these being serious in nature, including anaphylaxis requiring immediate medical care and in some cases hospitalization.

The FDA quickly came out with a statement of its own indicating it had received 19 reports of anaphylaxis occurring after peginesatide administration in dialysis centers, including three fatalities. The drug had been approved for anemia in adult patients undergoing dialysis for chronic kidney disease.

All lots of Omontys, sold in 10 milligram and 20 milligram vials, have been recalled and all health-care professionals have been told not to administer the medication.

Are you currently or were you taking Omontys? If so, and if you suffered any adverse reaction, you should consult with qualified legal counsel about your situation and your options. Visit the Omontys Recall Class Action Lawsuit Investigation to receive a free review of your claims. If eligible, you’ll receive a no-cost, obligation-free consultation with a qualified drug injury attorney who can walk you through the process of seeking the compensation you deserve.


 

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Updated April 1st, 2013

 

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