FDA: Omontys injection pulled from market

February 26, 2013
FDA: omontys injection pulled from market
Affymax Inc. of Palo Alto, Calif., and Takeda Pharmaceuticals Company Limited of Deerfield, Ill., have voluntarily recalled all lots of Omontys Injection, used to treat anemia in adult dialysis patients, following reports of serious and fatal hypersensitivity reactions, according to a safety recall issued by the U.S. Food and Drug Administration.

(HealthDay)—Affymax Inc. of Palo Alto, Calif., and Takeda Pharmaceuticals Company Limited of Deerfield, Ill., have voluntarily recalled all lots of Omontys Injection, used to treat anemia in adult dialysis patients, following reports of serious and fatal hypersensitivity reactions, according to a safety recall issued by the U.S. Food and Drug Administration.

The recall comes after reports of some patients experiencing serious and fatal hypersensitivity reactions following receipt of a first dose of Omontys, given by intravenous injection. The reactions, which occured within 30 minutes following the dose, were not reported following subsequent dosing or in patents who had completed their dialysis session.

The FDA has received 19 reports of anaphylaxis from dialysis centers around the United States, three of which resulted in death. Other patients required rapid medical intervention or hospitalization. Reports included patients who were able to be resuscitated.

"Due to the severity of the , we want to be certain that stop using Omontys," Howard Sklamberg, J.D., director of the Office of Compliance at the FDA's Center for Drug Evaluation and Research, said in a statement. "Americans deserve medications that are safe, effective, and of the highest quality. We are investigating the products and facilities associated with this recall and will provide updates as we learn more."

Explore further: Baxter issues urgent recall of Heparin

More information: More Information

Related Stories

Baxter issues urgent recall of Heparin

January 26, 2008

Baxter Healthcare has issued an urgent U.S. recall of nine lots of the injectable blood thinner heparin after reports of adverse patient reactions.

FDA: Ameridose issues voluntary recall of all products

November 2, 2012

(HealthDay)—Ameridose, a Massachusetts-based manufacturer of sterile injectable products and oral syringes, is undergoing a voluntary recall of all unexpired products in circulation, according to an Oct. 31 news release ...

FDA: Zofran 32-mg dose pulled from market

December 6, 2012

(HealthDay)—The 32-mg, single intravenous dose of Zofran (ondansetron), an anti-nausea drug, is being removed from the market due to its potential to cause serious, even fatal, cardiac damage, according to a Drug Safety ...

Recommended for you

Treatment options for opioid addiction are expanding

August 10, 2016

In the past two decades, the devastation associated with opioid addiction has escaped the relative confines of the inner city and extended to suburban and rural America. Due in large part to the proliferation of prescription ...

Can exercise be replaced with a pill?

October 2, 2015

Everyone knows that exercise improves health, and ongoing research continues to uncover increasingly detailed information on its benefits for metabolism, circulation, and improved functioning of organs such as the heart, ...

0 comments

Please sign in to add a comment. Registration is free, and takes less than a minute. Read more

Click here to reset your password.
Sign in to get notified via email when new comments are made.