FDA's Cardiovascular & Renal Drugs Advisory Committee will consider the clinical benefit of reducing the need for blood transfusion, as part of its evaluation of Bayer's Trasylol , at its Sept. 21 meeting.

Although the meeting was convened as a follow-up to a Public Health Advisory on safety issues, committee members will also be asked for their "perspectives regarding the clinical benefit associated with a reduction in the need for blood transfusion among certain patients undergoing coronary artery bypass grafting, especially in light of current surgical procedures and transfusion practices," according to FDA briefing material.

Originally approved in 1993, aprotinin injection received a broadened indication in 1998 for "prophylactic use to reduce perioperative blood loss and the need for blood transfusion in patients undergoing cardiopulmonary bypass in the course of coronary bypass graft surgery."

[Editor's note: To ¹ watch a webcast or order a video/DVD of this meeting, visit FDAAdvisoryCommittee.com.]

FDA issued a Public Health Advisory in February on the risk of renal dysfunction and myocardial infarction associated with Trasylol (² Also see "Trasylol Public Health Advisory Cites Kidney, Heart Attack, Stroke Risks" - Pink Sheet, 8 February, 2006.).

The committee will assess "the clinical meaningfulness of the findings from the two published observational clinical studies," which prompted the advisory. The data will be presented to the committee by the publication authors, the agency notes.

The committee will also review reports of hypersensitivity reactions. A summary of Trasylol-related hypersensitivity reports submitted by Bayer estimates 284 cases of hypersensitivity associated with the drug, 51 of which were fatal.

"FDA has special concerns regarding the findings from the sponsor's summary of hypersensitivity reactions. These concerns relate specifically to the occurrence of fatal hypersensitivity reactions as well as to concerns regarding the utility of the 'test' Trasylol dose procedure in light of the apparent failure to predict fatal hypersensitivity reactions," FDA states.

Labeling calls for a "test" dose to be administered 10 minutes prior to the loading dose. Nineteen of the 51 reported hypersensitivity fatalities were a result of the test dose alone.

Bayer has proposed a risk minimization plan emphasizing physician education and more in-depth history taking in response to reports of hypersensitivity. The sponsor has also proposed the development of a blood test to detect prior exposure to aprotinin; 28 cases of the hypersensitivity fatalities occurred in patients who had been previously exposed.

The committee will further be asked to consider potential label alterations to address safety and efficacy concerns.

-Mary Bruce (m.bruce@elsevier.com)

Trasylol Clinical Benefit To Be Reviewed By FDA Advisory Committee

More from Archive

More from Pink Sheet