Late last month the Food and Drug Administration (FDA) issued warnings to healthcare providers about the dangers associated with a popular anti-anemia drug commonly used in dialysis centers across the country. The warning came on the heels of a nationwide Omontys recall issued by the manufacturers, Affymax (Palo Alto, CA) and Takeda Pharmaceuticals (Deerfield, IL). The manufacturers pulled the plug on the drug after it came to their attention that a number of patients using Omontys had suffered severe reactions including death after being exposed to the drug.
Omontys was previously used to combat anemia during and after kidney dialysis treatments at non-hospital centers across the country. The drug, a copyrighted form of peginesatide delivered via intravenous injection, caused deadly anaphylaxis reactions within 30 minutes in .02 percent of 25,000 patients to whom the drug was administered for the first time. Anaphylaxis can cause extreme swelling of the tongue and throat, which can lead to difficulty swallowing and breathing. Affymax notified the FDA of 19 reports of anaphylaxis from dialysis centers across the country. Three of those cases resulted in death.
After the FDA was notified of the danger, the agency sent out a nationwide alert to dialysis centers, hospitals, and doctors’ offices. The director of the FDA’s office of compliance, Howard Sklamberg, said in a statement that “due to the severity of the public health risk, we want to be certain that healthcare providers stop using Omontys.”
News of the Omontys recall hit Affymax hard. Stock prices dropped as much as 85% immediately after the announcement. An FDA investigation is ongoing. The personal injury lawyers at Girard Gibbs LLP have also begun their own investigations into the Omontys recall.