Omontys Allergic Reaction Problems Appeared Soon After Drug Approved

Within months after the FDA approved Omontys early last year, troubling adverse event reports about serious and lethal allergic reactions began to surface, which ultimately caused the anemia drug to be recalled from market earlier this year. 

Omontys (peginesatide) was first released in April 2012 as a joint effort between Takeda Pharmaceuticals and Affymax for treatment of anemia in dialysis patients.

According to a recent report by the Wall Street Journal, by August 2012, the FDA was receiving information about severe and sometimes deadly anaphylaxis reactions during a pilot program at Fresenius dialysis centers.

An Omontys recall was issued by February 2013, after it was determined that the potential risks outweighed the benefits. About 25,000 patients were treated with the Omontys before it was removed from the market, most of which received the anemia drugs during treatment at Fresenius dialysis centers.

At least 98 adverse event reports were received by the FDA between the release of Omontys and the recall.

Information about the Omontys allergic reaction problems reported to the FDA were revealed through Freedom of Information Act requests, highlighting for the first time how quickly the side effect began to emerge.

There were at least 12 deaths among Omontys patients where the drug may have been a factor, but the causes of death were not specified. The drug makers said they looked at five deaths before making the decision to recall the drug. At the time of the recall, only three deaths were disclosed, and 19 cases of serious side effects.

It appears that the drug makers were aware there was a risk of serious problems with Omontys by fall 2012. Affymax officials say they contacted the FDA about adding an updated warning label to the drug once the adverse event reports began to come in.

Allergic reactions on Omontys appeared to occur within 30 minutes of the first injection, which is designed to be given once per month. According to Affymax and Takeda, the reactions occurred in about 0.2% of cases, with about a third of those being serious and sometimes including anaphylaxis that requires prompt medical intervention and hospitalization. Fatal reactions occur in about 0.02% of all cases, according to the manufacturers.

Affymax Inc.’s share prices tumbled after the recall and the company announced in a press release last month that  is considering bankruptcy after laying off 75% of its workforce late last month, including its chief commercial officer. The company says the downsizing was so that it could focus on an ongoing investigation into whether Omontys was still a usable product.