FDA alerts health care providers of recall of anemia drug Omontys.
The U.S. Food and Drug Administration is alerting health care providers and patients of a voluntary nationwide recall of all lots of Omontys Injection by Affymax, Inc., of Palo Alto, Calif., and Takeda Pharmaceuticals Company Limited, of Deerfield, Ill. The recall is due to reports of anaphylaxis, a serious and life-threatening allergic reaction. Omontys is used to treat anemia in adult dialysis patients.
Until further notice, health care providers should stop using Omontys and return the product to Takeda Pharmaceuticals.
According to the companies, serious and fatal hypersensitivity reactions have been reported in some patients receiving their first dose of Omontys, given by intravenous injection. The reactions have occurred within 30 minutes following the dose. There have been no reports of reactions following subsequent dosing, or in patients who have completed their dialysis session.
The FDA has been notified by Affymax of 19 reports of anaphylaxis from dialysis centers in the United States. Three of the anaphylaxis cases resulted in death. Other patients required prompt medical intervention and in some cases hospitalization. Some of the reports included patients who were able to be resuscitated by doctors. However, anaphylaxis is life-threatening and resuscitation efforts are not always successful.
BTW... Anaphylaxis is a serious allergic reaction that is rapid in onset and may cause death. It typically causes a number of symptoms including an itchy rash, throat swelling, and low blood pressure. Common causes include insect bites/stings, foods, and medications.
On a pathophysiologic level, anaphylaxis is caused by the release of mediators from certain types of white blood cells triggered either by immunologic or non-immunologic mechanisms. It is diagnosed based on the presenting symptoms and signs. The primary treatment is injection of epinephrine, with other measures being complementary.
Worldwide 0.05–2% of people are estimated to have anaphylaxis at some point in their life and rates appear to be increasing. The term comes from the Greek words ἀνά ana, against, and φύλαξις phylaxis, protection.
From Wikipedia, the free encyclopedia
Folks, this post and the subsequent one from Maxdad are exactly the precise wording that comprises the greatest part of our DD. This is an enhancement that, once digested, will bring in some additional buyers. I believe that the FDA has in mind the language it would like to see relative to minimizing going forward human errors. Now the question is "Can Fresenius bite the bullet, sign off on corrective action, and allow O to be administered once again?" I am sure that Takeda is working with Fresenius as an assist but most likely at arm's length.
Sentiment: Strong Buy
I hear ya Max, but for whatever reason investors are staying away at $1.60. If a good portion of the investment community had your conviction of a Omonty return, the stock would be trading much higher.
Maybe they believe the big pharma conspiracy of being able to keep competing drugs off the market? We know there is lots goin on between the fda and big pharma.
I just hope the bet you have made on a return is one you can swallow if things dont turn out well.
Poker - If "a good portion of the investment community had (Maxdad's) conviction" then we most likely wouldn't be looking at AFFY as it would be priced higher and the risk/reward favorability would be less. There are plenty of diamonds that the crowds overlook.
What is going on between FDA and big pharma has nothing to do with us. The O recall was not an FDA call. They are involved as a matter of courtesy and good business sense.
Lastly, why are you questioning MD's ability to "swallow" that which he has bitten into? That is his business, just as the amount I and others have bitten is our business. Don't worry, none of us will choke, and we will not be pointing any fingers at each other. We have done our DD in a systematic manner, shared with each other when we have something useful to offer, and are awaiting the results. Your input, if it is not soft bash, is at best amateurish as you are mixing apples with oranges with your "If"s and your words of hope are faint. Please cease, sit back, and observe patience, prudence, and experience at work. Jim
Sentiment: Strong Buy