Baxter get FDA warning for Feiba VH claims

The FDA have warned Baxter for making misleading claims for Feiba VH. There are many points made such as :
"the following adverse events, but not limited to, that are reported in the referenced studies1-5 to support the safety claim are inconsistent with the term “well-tolerated”:
“Seven minor adverse reactions, including minor chest pain and tightness, drowsiness, and discomfort in breathing” and “evidence of liver dysfunction was seen in three patients.”2
“chills, fever, nausea, dizziness, and an unusual taste in the mouth” 3
“Three patients contracted clinically overt hepatitis.”4
“For FEIBA there were 40 total reports [MedWatch Reports], of which 11 [>25%] were thrombotic events.” 1
“…a myocardial infarction occurred one hour after the second infusion of FEIBA in a 41-year-old hemophilia B patient…The second dose …increased the circulating Factor IX level until 58%. The combination between this increase in plasma coagulant activity and pre-existing risk factors…might have been responsible for the thrombotic complication.” 5
As a result, the above statements promote the potential unsafe administration and use of FEIBA. If you have adequate and well controlled data to support such claims, please submit the data to FDA to review."

The full letter is posted on the FDA website HERE
BackgroundAccording to the FDA-approved prescribing information (PI), FEIBA VH is a freeze-dried sterile human plasma fraction with Factor VIII inhibitor bypassing activity and is indicated for the control of spontaneous bleeding episodes or to cover surgical interventions in hemophilia A and hemophilia B patients with inhibitors. FEIBA VH is contraindicated in patients who are known to have normal coagulation mechanism.