The Florida pharmaceutical defect attorneys at Farah & Farah have learned that the U.S. Food and Drug Administration (FDA) has announced that all lots of the anemia drug, Omontys, which is used in conjunction with kidney dialysis, have been recalled due to allergic reactions that have injured – and even killed – some patients.
The FDA says it received 19 reports of anaphylaxis, a severe allergic reaction, and that three patients had died as a result. The others required hospitalization or prompt medical intervention to save their lives.
Takeda Pharmaceutical and Affymax, which jointly market the drug, have claimed that “hypersensitive reactions” from the use of Omontys are rare and according to their findings occur in two out of every 1,000 patients. Strangely, the companies reported that five deaths had been linked to allergic reactions caused by the drug – a discrepancy from the three deaths reported by the FDA.
According to The New York Times, Fresnius Medical Care North America, which is the largest dialysis provider in the nation, stopped a pilot program it was conducting with Omontys due to allergic reactions that patients were experiencing.
Although Omontys has been recalled, the Times reports that it is still unclear whether the drug will be completely withdrawn from the market. One kidney specialist interviewed by the Times said that other drugs could be used to replace Omontys in the interim and that it may prove difficult for Takeda and Affymax to prove the drug is safe without conducting a large study.
Have you or a loved one been harmed due to the side effects of a drug? You may be entitled to compensation for medical bills, pain and suffering, and other damages. It is a pharmaceutical manufacturer’s obligation and duty to assure that its drugs are safe for the public. If you believe you have a case, call Farah & Farah at (800) 533-3555 or contact us online. The review of your case is free and there is no obligation on your part.