The U.S. Food and Drug Administration announced a recall of all lots of Omontys (pegniesatide) after serious hypersensitivity reactions occurred.
Omontys injection is produced by Affymax and Takeda and is used in the treatment of anemia due to chronic kidney disease in adult patients on dialysis. It was approved the FDA in March 2012.
Fatal reactions have occurred in approximately 0.02% of patients and the reaction has occurred within 20 minutes of administration of the injection. More than 25,000 patients have received Omontys since its release.
Diaylysis organizations have been instructed to discontinue use of Omontys immediately. If you are a dialysis patient, it is worth it to confirm your center has discarded this medication.
Furthermore, if you are a patient that had a serious reaction and required medical intervention after receiving dialysis, report this information to the FDA. In addition, you may have legal rights and should consider talking to a lawyer.
The Legal Examiner and our Affiliate Network strive to be the place you look to for news, context, and more, wherever your life intersects with the law.
Comments for this article are closed.