Recalled Omontys Side Effects Now Linked to 22 Deaths

The side effects of the anemia drug Omontys, recalled after less than a year on the market, may have been far worse than what was initially reported, according to a new analysis.  

An Omontys recall was announced earlier this year after an investigation into five deaths that appeared to be caused by lethal allergic reactions. Since then, with the exception of a Wall Street Journal report in March 2013, there has been little word on the drug’s side effects during its short run.

The investment website Seeking Alpha began to raise questions after Omontys was recalled in February of this year, as there were no further reports from the manufacturers, Affymax and Takeda Pharmaceuticals, or the FDA.

Probing into the FDA’s adverse event reports, Seeking Alpha reports that it has identified at least 22 deaths that may be related to Omontys side effects, which is substantially more than prior estimates.

The report, published on October 14, looked at 107 pages of adverse event reports submitted to the FDA.

Omontys Risk of Allergic Reactions

Omontys (peginesatide) was introduced in April 2012 for the treatment of anemia in dialysis patients. It was used primarily at Fresenius dialysis centers as part of a pilot program. By August 2012, the FDA was receiving reports of severe and sometimes deadly anaphylaxis reactions to the drug.

By February 2013, the manufacturers recalled Omontys after it was determined that the risks outweighed the potential benefits. Initially, only three deaths were announced, but that number was later increased to five. Later reports suggested 12 Omontys deaths may have occurred before the recall. That number has now been increased to 22 deaths. 

About 25,000 patients were exposed to the drug before the recall. However, adverse event reports submitted to the FDA typically only represent about 1% to 10% of all adverse events actually associated with prescription medications.

Among the deaths identified, at least one involved a patient who received a subcutaneous injection, as well as several nonfatal adverse event reports. This is noteworthy because Affymax ex-CEO John Orwin previously denied any such reports existed and claimed the company hoped to reintroduce Omontys as subcutaneous-only drug.

Omontys allergic reactions typically began to appear within 30 minutes of the first injection, which is designed to be given once per month.

According to information previously released by Affymax and Takeda, the Omontys problems 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.