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MASAC Recommendation #157- MASAC RESOLUTION ON THROMBOGENICITY OF BYPASSING AGEN
 

MASAC Document #157

MASAC RESOLUTION ON THROMBOGENICITY OF BYPASSING AGENTS FOR MANAGEMENT OF HEMOPHILIA COMPLICATED BY INHIBITORS

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The following recommendations were approved by the Medical and Scientific Advisory Council (MASAC) of the National Hemophilia Foundation on November 6, 2004, and adopted by the NHF Board of Directors on November 7, 2004.

Whereas MASAC is concerned about the safety and efficacy of all replacement therapies prescribed for individuals with hemophilia;

Whereas thrombosis is a rare but well recognized potential complication of bypassing agents used in the treatment of hemophilia complicated by inhibitors and acquired hemophilia;

Whereas the incidence of thrombotic events associated with the use of these bypassing agents remains difficult to determine; and

Whereas the concerns regarding the thrombotic potential of these agents have been heightened by recently published, peer-reviewed articles in the medical literature which have described thrombotic adverse events,

Be it resolved:

That MASAC, as an independent advisory group, evaluate the various data bases that may include information on the incidence of thrombotic adverse events associated with the use of bypassing agents;

That MASAC accomplish this task in conjunction with the FDA and the manufacturers and distributors of these products (Baxter-Immuno, NABI, NovoNordisk), as well as with the Hemophilia and Thrombosis Research Society (HTRS) and the CDC, which maintain active data bases for the hemophilia community; and

That the Chair of MASAC appoint a subcommittee to complete this task in an urgent time frame and then to disseminate this analysis throughout the hemophilia community and in the medical literature.