MultiDose Vials only problem! Somebody tampered the content...Investigation on
Pharmafile reported On a conference call, Affymax chief medical officer Anne-Marie Duliege noted that 25,000 patients have been treated with Omontys since launch, with hypersensitivity reactions seen in 0.2% of cases. This was about the same rate as seen in clinical trials, but the seriousness of the reactions was considerably less during testing, she added.
Clinical testing was carried out on single-dose vials, and the reactions have occurred among patients treated with Omontys taken from multidose vials, but Affymax stressed on the call that it is too early to speculate on possible manufacturing issues or other causes.