FDA questions labeling of blood drug therapy

Tainted Heparin, a blood thinner medication, manufactured by Baxter International has been directly linked to the deaths of three people as reported previously on this Baxter heparin recall blog.

Most recently, the FDA criticized Baxter International for misleading doctors about FEIBA VH's safety. FEIBA VH is a bleeding treatment drug therapy for people with hemophilia.

The FDA criticized the statement:

"FEIBA is well tolerated in 96%-100% of infusions with a low thrombotic event incidence (0.008%)"

According to the FDA, this is exaggerated.

The FDA requested that Baxter immediately cease the dissemination of the offending email letter as well as any same as or similar violative promotional materials for FEIBA VH.