Here is the actual text from FDA site. 50 People had (.2% of 25000) reactions.
Withdrawal was due to suspicion of Manufacturing issues, since the Mfg issues are not reported, the product will be coming back along with an Enhanced first day administration. Of course Takeda is doing to evaluation, so one should know what is expected.
Omontys (peginesatide) Injection by Affymax and Takeda: Recall of All Lots - Serious Hypersensitivity Reactions
ISSUE: Affymax, Inc. and Takeda Pharmaceutical Company Limited along with the U.S. Food and Drug Administration (FDA) are informing the public of a voluntary recall of all lots of OMONTYS® (peginesatide) Injection to the user level as a result of new postmarketing reports regarding serious hypersensitivity reactions, including anaphylaxis, which can be life-threatening or fatal.
To date, fatal reactions have been reported in approximately 0.02% of patients following the first dose of intravenous administration. The reported serious hypersensitivity reactions have occurred within 30 minutes after such administration of Omontys. There have been no reports of such reactions following subsequent dosing, or in patients who have completed their dialysis session. Since launch, more than 25,000 patients have received Omontys in the postmarketing setting. The rate of overall hypersensitivity reactions reported is approximately 0.2% with approximately a third of these being serious in nature including anaphylaxis requiring prompt medical intervention and in some cases hospitalization.
Yes. You should be ashamed of yourself jagan for your mindless, incessant cheer leading with no substance behind them. You repeat the same old pumper lullaby about O's recall and allergic reactions being attributable to manufacturing issues which has been thoroughly debunked.
In the AFFY CC following O's recall, Orwin admitted that the allergic reactions were geographically diverse and not limited to a specific lot or lots of Omontys. Likewise, in the recent Fresenius CC, it was reported that Takeda was looking to a DNA type test to see if it could learn if there was something about the patients that made them allergic to the drug.
Here is an allegation from the amended complaint in securities class action that is also instructive:
Defendant Orwin admitted that he knew as of the fall of the adverse events related to the drug, but that he was investigating whether the adverse reactions were a result of a “manufacturing flaw” versus the drug itself. However, a Confidential Witness, a former field educator at Affymax in Dallas, TX(“CW 1”) stated that the problem was not a manufacturing flaw because if Affymax could have shown that the problem with OMONTYS was due to a manufacturing flaw, the Company could have just pulled that particular lot rather than a total recall.
RIGHT THERE CONMAN...You made the point PERFECTLY...Allergic (Anaphylactic) reaction which happens to be experienced by 100's of drugs on the market, where Omontys will be as well once this investigation is over. In the meanwhile, unlike your countless prediction, Affymax is still alive and well (albeit dormant with hardly any expenses) and awaiting the investigation results.
IF ALLERGIC REACTIONS WERE CAUSE TO REMOVE A DRUG PERMANENTLY, we would have literally HUNDREDS OF DRUGS taken off the market...Surely you must know this particularly since only 3 had such severe anaphylactic reactions (WHICH WERE OBVIOUSLY NOT PROPERLY HANDLED, THOUGH THAT IS A SIMPLE THING TO DO), that there would have to be something TOTALLY OTHER THAN ANAPHYLAXIS for Omontys to be permanently cancelled. BUT you wouldn't be here 24/7 bashing your brains out if you actually believed that it was something OTHER than an allergic/anaphylactic reaction resulting in insufficient medical care by Fresenius personnel.