From O post-marketing experience, patients treated with O with hypersensitivity reactions are real patient safety issues. Per CHMP/EMA report, Through 12 February 2013, O has been a total of 59 (reporting rate 0.2%) patients who have experienced hypersensitivity reactions. Of these 59 cases, 23 cases (reporting rate 0.1%) were considered serious. In 5 cases (reporting rate 0.02%) the outcome was fatal. In another 6 cases, the case was considered to be life-threatening.
From MedWatch (CIOMS) reports, we see the chaotic & error treatments by medical staffs for patients treated with O with hypersensitivity reactions - administered Benedryl. Using Epinephrine or autoinjectable epinephrine (eg, EpiPens) or others, we should expect that one of Takeda tasks is to elaborate on the immediate hypersensitivity reactions treatment & management system being put in place to mitigate the risk of serious hypersensitivity reactions, in patients treated with O.
That's right. Blame the nurses and dialysis centers and not O. Kind of reminds me of Maxdad when he stated that nurses should go to jail for O deaths. Recall the PEARL studies, and O's rate of "sudden death", among other disasters insofar as patient safety is concerned. Here are the PEARL statistics:
Sudden death - 2.1% O, 0.3% Epo [O 7x more]
Death from unknown cause- 2.4% O, 1.2% Epo [O 2x more]
Unstable angina - 2.4% O, 0.9% Epo [O 2.6x more]
Arrythmia - 5.6% O, 4.0% Epo [O 1.4x more]
Acute Renal Failure - 8.5% O, 4.3% Epo [O 2x more]
Convulsions - 1.2% O, 0.3% [O 4x more]
Treatment Failure - 3.5% O, 1.5% Epo [O 2.3x more]