Drugmakers Takeda and Affymax recently announced a recall of their anemia drug Omontys. The drug has caused anaphylaxis in some patients, which has caused some patients to die.
The Mayo Clinic describes anaphylaxis as a severe allergic reaction which is caused by the immune system releasing dangerous amounts of chemicals into a patient’s system in response to an allergen such as a drug. Patients suffering from anaphylaxis can go into shock and suffer a serious drop in blood pressure that blocks breathing.Omontys (peginesatide) was marketed to treat anemic kidney dialysis patients. Many doctors have stopped prescribing this defective pharmaceutical because it is more dangerous than the alternative drug, called Epogen.
“Since launch, more than 25,000 patients have received Omontys in the postmarketing setting,” the FDA recall notice states.
“To date, fatal reactions have been reported in approximately 0.02% of patients following the first dose of intravenous administration. The reported serious hypersensitivity reactions have occurred within 30 minutes after such administration of Omontys.”
“Two in 10,000 deaths on first exposure is unacceptable, compared to nothing like this with Epogen,” one doctor said.Forbes reporter Agustino Fontevecchi is speculating that the recall might spell the end of Affymax, Inc. The drug makes up most of Affymax’s revenues and there are no other known projects in the works.
The company’s stock reportedly dropped 80 percent today on the recall news.