FDA Adverse Event Report For Omontys Reveals Affymax And Takeda May Have Downplayed Magnitude Of Problems
When the dialysis - anemia medication Omontys was recalled in February 2013 it was reported that five patients had died due to intravenous use. Since then, there has not been much information about these Omontys associated deaths from the responsible drug companies, Affymax and Takeda, nor the FDA.
We now have an update on the Omontys situation from a financial web site, SeekingAlpha.com, which published this article on October 15, 2013: "New Data Show Omontys At Least 4x Worse Than Reported: Now 22 Suspected Deaths".
From this SeekingAlpha article about the Omontys recall situation we get these excerpts:
- In our effort to get to the bottom of the Omontys saga, we asked the FDA to send us the Adverse Event report for Omontys, which can be found in its entirety here (107 pages long). The data shows there have been 22 deaths in which Omontys was reported to be the most likely cause of death!Furthermore, the report shows there has been at least one death (multiple additional cases of adverse events) reported as a result of subcutaneous administration of Omontys.
- We were surprised at the sheer volume of serious adverse events reported in relation to Omontys, and were reminded of something Dr. Steven Nissen said about the risks vs. benefits of Omontys at a 2011 FDA ODAC meeting: "So what I'm fearful will happen is that…you're going to be back here in front of this committee in the future, as you have been in the past, with this drug [Omontys], as you have with other drugs, with some surprises down the road."
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To bring you up to speed, if previously unfamiliar with this Omontys drug safety issue, we refer you to our two previous articles:
Fate Of Affymax Anemia Drug Omontys Remains Uncertain As FDA And Drug Company Continue To Study Cause Of Drug Reactions (4/1/13)
We will continue to monitor this relatively small-scale but serious drug safety issue concerning Omontys.
Further, we are currently working on some drug injury lawsuits involving Omontys.