Market Minute: Affymax, Takeda Recall Anemia Drug Omontys After Deaths

TOKYO/WASHINGTON -- U.S.-based Affymax Inc (AFFY) and Japan's Takeda Pharmaceutical Co (TKPYY) said they are voluntarily recalling all lots of anemia treatment Omontys (peginesatide) in the United States due to reports of serious hypersensitivity reactions, including some deaths.

As of Sunday, fatal reactions to the injection have been reported in about 0.02 percent of 25,000 patients after receiving their initial injection of the treatment, Affymax said in a statement.

pillsThe drug is used to treat anemia in adult dialysis patients, and has resulted in reports of serious allergic reactions known as anaphylaxis in some recipients.

The U.S. Food and Drug Administration on Sunday alerted healthcare providers about the recall, and said it had received 19 reports of anaphylaxis from dialysis centers in the United States.

"Due to the severity of the public health risk, we want to be certain that healthcare providers stop using Omontys," said Howard Sklamberg, who heads the compliance office at the FDA's Center for Drug Evaluation and Research.

Sklamberg said the agency is investigating the products and facilities related to the recall and will provide updates once it receives more information.

(Reporting by James Topham in Tokyo and Aruna Viswanatha in Washington; Editing by Nick Macfie and Dale Hudson)

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Rumor has it the FDA is supposed to verify the safety of pharmaceuticals BEFORE the public is subjected to them, but they may function like the FAA that approved the Boeing 787 as air worthy or the Homeland Security/Boarder Patrol/ICE bureaucracy that let those 11,000,000 million undocumented immigrants in or maybe the DEA that did such a great job with the "War on Drugs" that politicians are pushing legalization.

February 25 2013 at 5:27 PM Report abuse rate up rate down Reply
Bob Mull

aspirin probably causes as many deaths

February 25 2013 at 3:38 PM Report abuse rate up rate down Reply
Bob Swintosky

0.02% is 1 in 5000, or about twice your chance of dying on the roadways of this fine country (2011 33,000 fatalities in a country of 310 million). I know math and statistics are hardly strong points for most of our fellow citizens, but try to have some vague idea before making comments about how Big Pharma is slaughtering its patients right and left.

February 25 2013 at 3:28 PM Report abuse rate up rate down Reply
crazy ray

Well, I guess that's one cure for anemia: killl the patient.

February 25 2013 at 2:23 PM Report abuse rate up rate down Reply

still nothing bout gas prices.....gee,wonder why

February 25 2013 at 12:08 PM Report abuse rate up rate down Reply
1 reply to greatonenonly's comment

It's because this story is not about gas.

February 25 2013 at 2:57 PM Report abuse rate up rate down Reply

.02% of 25K is 5 people. I know it's tragic but what about the 24995 people the drug has helped? There is no way to make a drug that is 100% effective on all people or 100% safe for all people, especially people who are compromised by illness. All you do when you pull a drug after such a small sampling of people are impacted is remove a drug that helps others.

February 25 2013 at 10:04 AM Report abuse -3 rate up rate down Reply
2 replies to bree_zee's comment

there are other pharmaceuticals proven to work without this number of deaths due to a severe allergic reaction.

February 25 2013 at 10:19 AM Report abuse +4 rate up rate down Reply
crazy ray

Actually, the normal statistics onf 25K give a standard deviation of less that 0.07%, so, statistically, nobody really died.

February 25 2013 at 2:25 PM Report abuse rate up rate down Reply