New Anemia Drug Omontys Recalled Following Deaths, Allergic Reactions Among Dialysis PatientsFeb 26, 2013
Already facing legal troubles for its dangerous diabetes drug, Takeda Pharmaceuticals is now recalling its new anemia drug Omontys, dispensed to patients undergoing kidney dialysis, after several fatal reactions were reported.
According to a New York Times report, Takeda and Affymax, another company marketing this new anemia drug, ordered all shipments of Omontys back on Saturday because of the risk of more life-threatening allergic reactions among dialysis patients treated with it.
The Food and Drug Administration added that it has 19 reports of people who suffered anaphylaxis after receiving a course of Omontys as part of their dialysis treatment. Among those, three people have died as a result of their allergic reactions. The other 16 cases of anaphylaxis required emergency treatment and hospitalization to prevent more harm.
Omontys was only approved in March 2012 and broke onto the market as an alternative to Epogen, another anemia drug that appeared to have that market cornered despite its own link to dangerous side effects.
The drug companies responsible for Omontys say that about 25,000 people nationwide receive this drug in conjunction with their dialysis treatment to prevent anemia. They also reported that fatal reactions have been reported in two one-hundredths percent of those patients. The Times notes that that figure would make the total deaths five, not three, but no explanation for that difference has been given. The risk of a severe allergic reaction, according to the drug companies’ estimates, is about 2-in-1,000 patients.
If a patient treated with Omontys is going to suffer a severe allergic reaction it is likely to occur within the first half-hour after receiving the first IV treatment they receive of the drug. Omontys is prescribed once a month after the first dose. No allergic reactions have been reported among any patients who received the drug after that telltale first dose.
Despite that profile, the companies along with the FDA have ordered all shipments of the drug recalled, even if patients undergoing dialysis appear to accept the drug without complication. Whether or not Omontys remains on the market will be determined by future studies that determine whether it is the drug or specific dialysis centers that may be the source of the allergic reactions brought on after the drug is delivered.
A trial involving Omontys was halted by Fresenius Medical Care earlier in February after patients treated with the drug at the company’s many dialysis treatment centers had developed severe allergic reactions.