"• At the 200 mg/kg dose, of 10 animals 5 died acutely, and one additional female in the group showed LABORED BREATHING; …”
From the FDA brief...
"There was a case of study drug overdose in the fidaxomicin group followed by duodenal perforation (subject 003-137011).
The next day after the overdose, on study day 4, the patient developed hypotension, anuria, RESPIRATORY FAILURE and required mechanical ventilation...”
"The overall severity of GI hemorrhage appears to be somewhat greater in the fidaxomicin group. Two fidaxomicin patients stopped study drug due to GI hemorrhage and one patient in the fidaxomicin group died from GI hemorrhage.”
fidaxomicin- patient 025008 died of gastrointestinal perforation
fidaxomicin- patient 05022 died of RESPIRATORY FAILURE/megacolon (different patient that's mentioned above).
"Plasma levels of fidaxomicin and its metabolite OP-1118 were higher in subjects in phase 3 trials than in healthy volunteers. Phase 3 trial subjects had levels of fidaxomicin and OP-1118 up to 237 ng/mL and 871 ng/mL, respectively…”
"A possible explanation for these findings is that more severe CDAD may be associated with poor intestinal integrity and higher systemic absorption, leading to higher fidaxomicin plasma levels."
Some words highlighted for emphasis.
I see it now....
A CDI patient goes in the hosp with wife... ehhh, significant other... just wanna be politically correct. right professor, phaseiii?...
SO tells doctor, 'Hey doc can you give da one dat kills rats at 200 mg IV?... I'd like to see him rid of CDI forever...'
The troubling pattern Kamoa, is another big up day for OPTR on the way, and more red in your shrinking brokerage account.
Still a large amount of short shares on loan. Will be like huge shark feeding frenzy off the coast of Hawaii, to get some shares. Kamoa don't surf today.
We will miss your aloha messages after you are taken down off your surf board by great white OPTR.
SOS for Kamoa!!
goood morning! yesortoni!
you are right, i am not surfing today, had too much of it in the past few days...
thanks for looking out for me though...
i'll return the favor of warning you of the sharks plying here... they'll corrall the unsuspecting and uninformed and before you know it whooomp! blood in da water...
It is quite interesting that the rat study paralled the drug's adverse events in human patients. It was even more interesting that it was noted in the rat study in the first place!
There's no doubt fida caused the respiratory failure of the rat...
But is it the cause of respiratory failures of the two patients ending in one death? NOte; None was observed in the comparator drug.
Of importance also is the gastrointestinal hemmorhaging. There were several of this vs. the comparator drug.
Although not readily apparent to some (because they are blinded with blissful love for fida), 237 ng/mL fida and 871 ng/mL OP-118 is a tiny amount. If this is what caused the respiratory failure and gastrointestinal hemorraging of a mild to moderate CDI patient, what would it do to a patient with a severe to life threatening case of the disease? hmmmmm....