The drug Omontys, which is used to treat anemia in kidney dialysis patients,
has been recalled by the Food and Drug Administration (FDA) and its manufacturers,
Affymax and Takeda Pharmaceuticals. According to a recent article in
The New York Times, there had been reports that three patients suffered severe allergic reactions
to Omontys, which resulted in their deaths.
According to the FDA, nineteen reports of anaphylaxis, a severe allergic
reaction, have been linked to the drug. The patients who were affected
required immediate medical treatment or hospitalization, and three of
them suffered death due to the reaction. Although the manufacturers state
that initial allergic reactions can be controlled and that they don’t
tend to re-occur with subsequent doses of the medication, the FDA has
required a recall until questions related to the drug’s use and
risks can be resolved.
Omontys (peginesatide) was approved by the FDA in March 2012 for the treatment
of anemia related to kidney dialysis. It was only the second such medication
on the market, following Amgen’s Epogen, which has been available
since 1989. Fresenius Medical Care North America, the country’s
single largest provider of dialysis services, stopped treating its own
patients with Omontys earlier this year due to concerns about allergic
reactions and other side effects.
If you’ve suffered a serious illness or injury related to a drug
that was later recalled, please don’t hesitate to contact the experienced
San Jose recall injury attorneys at Caputo & Van Der Walde LLP. For a free and confidential consultation,
contact us today at (800) 900-0863.