Omontys injection probably caused anaphylaxis in the patients that died. This type of hypersensitivity reaction can be prevented by skin testing patients or injecting a very small quantity prior to full dose administration. Also patients likely can be desensitized to the drug using protocols similar to what immunologist use for patients with severe penicillin allergies. Also, coadministration with steroids might prevent the problem. Either way, there's alot more clinical use for this drug than shorts such as Adam Fakestein will have you believe. 99.8% of patients have no issues with this drug. It was recalled to further study the cause and to prevent the 0.2% who it adversely affects.
Agreed, the overall convenience of Omontys administration is huge compared to a one time, simple screening test prior to initial dosing. Advantages of patient compliance and much lower medical labor cost will drive this to its potential. If they haven't offered already, Amgen will be keen to acquire this product and maintain their monopoly. Price back to where it was and then some. Just a matter of time.
First, the company will have to supply data to the FDA to determine the type of hypersensitivity reaction drug causes. Suspect Type I given anaphylaxis as the likely cause of death. Skin testing can then be proposed as the way to identify patients at risk. It will take the company time to obtain the medical records of the deceased. It will also take more time to meet with the FDA and satisfy their reviewers regarding the adverse events and prevention protocol. Look for company to release data analysis of adverse events in the coming weeks.
Dude nobody in a busy dialysis unit has time to skin test patients and giving prednisone to dialysis patients rather than just have them take epo is ridiculous...they are going bankrupt, I just can not figure out how to profit from it.
Yes, a one-time skin test would be too much hassle to get on a drug which needs to be administered once per month instead of epo's twelve. Please think a little.
The Dialysis RN usually has adequate time to monitor the patient. it's one of the least busy areas of nursing, not that it is not specific to certain complications. A SQ test could more than certainly be done to identify potential reactions. jmo
It only takes 1 test to determine if you are hypersensitive to Omontys or not. This saves at least a dozen injections a month for the patient and the dialysis center. If you do the math, it is much more convenient to administer Omontys than to give epo/procrit every time you get dialysis. Also, what about the 99.8% of patients who benefited without any side effects. I am sure they are bummed that the drug was pulled for further research. Anyways, it will be pretty easy for AFFY to demonstrate who the at risk patients are and to come up with a plan to prevent future events. This kind of stuff happens all the time in pharmaceuticals. Patients have died from taking plavix with omeprazole, so doctors don't use the same combination. Plenty of patients develop anaphylaxis from various drugs, most commonly antibiotics, but they are still used every single minute. Look, the shorts are having a field day today. It will only be a matter of time before this drug is used again with tighter control. Remember when Metformin was banned because of lactic acidosis? Well, almost every diabetic is now on it. What about thalidomide. Just saying, the medical industry will have use for a drug that they have spent $billions in developing.