The prescribing information for Adzynma, the only approved enzyme replacement therapy for an ultra-rare and potentially fatal clotting disorder, now carries the FDA's most serious form of warning. The label states that neutralizing antibodies against ADAMTS13, with serious outcomes including death, have been reported in patients treated with the drug.
The warning arrived through an unusual route. Federal documents show the agency and the manufacturer could not agree on the language, and the FDA ultimately issued a formal order compelling the change.
