
(Reuters) -The U.S. Food and Drug Administration is probing the death of a patient who developed harmful antibodies after taking Takeda Pharmaceuticals' blood disorder therapy, the health regulator said on Friday.
The pediatric patient died about 10 months after starting Takeda's drug Adzynma as a preventive therapy, the agency said.
The child had congenital thrombotic thrombocytopenic purpura (cTTP), an inherited condition that causes blood clots in small vessels and can lead to organ damage.
The FDA said the child developed antibodies that blocked the activity of ADAMTS13, an enzyme critical for blood clotting.
Takeda did not immediately respond to Reuters request for comment.
Adzynma, approved in 2023 as the first therapy for cTTP, replaces the ADAMTS13 protein to help prevent dangerous blood clots.
The agency added it has received multiple postmarketing reports of patients developing neutralizing antibodies to ADAMTS13 after treatment with Adzynma.
(Reporting by Kamal Choudhury in Bengaluru; Editing by Vijay Kishore)
LATEST POSTS
- 1
'Seditious behavior': Trump accuses Democrats who made video reminding the military not to follow illegal orders of a crime — but is it? - 2
‘The White Lotus’ sparked online interest in risky anxiety pills, study says - 3
Elite Execution Wall televisions for Film Darlings - 4
Can scientists detect life without knowing what it looks like? Research using machine learning offers a new way - 5
Pick Your Favored kind of sandwich
US EPA will reassess safety of herbicide paraquat, says its chief
Germany's Bundestag extends two armed forces missions abroad
6 Popular Ladies' Aromas On the planet
Instructions to Upgrade the Mechanical Highlights of Your Shrewd Bed for a Superior Night's Rest
6 Famous Urban communities for Shopping on the planet
Knesset FADC extends emergency draft for 280,000 IDF reservists until January 1
If evolution is real, then why isn’t it happening now? An anthropologist explains that humans actually are still evolving
Bondi Beach survivor criticizes police for inaction during terror attack
The most effective method to Engage in Local area Making arrangements for 5G Pinnacle Establishments













