EMA Recommends Lifting Suspension of Aprotinin
The EMA has concluded that aprotinin’s benefits in preventing blood loss outweigh its risks in patients undergoing isolated heart bypass surgery who are at high risk of major blood loss.
The European Medicines Agency has recommended that the suspension of the marketing authorisations for aprotinin-containing medicines in the European Union (EU) be lifted.
This follows a full review of the benefits and risks of all antifibrinolytic medicines, which found that the results of the BART study on which the suspension was based are unreliable.
Aprotinin is an antifibrinolytic medicine, which prevents excessive blood loss. It works by preventing the breakdown of fibrin, a protein found in blood clots. Prior to its suspension in 2008, aprotinin was authorised for patients undergoing heart bypass surgery.
The Agency’s Committee for Medicinal Products for Human Use (CHMP
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