Cinacalcet Does Not Up Risk for Severe Gastrointestinal Bleeding in Hemodialysis
Study is the largest to explore this potential safety issue to date.
Bleeding Disorders
FDA Issues Safety Alert Regarding Use of Hydroxyethyl Starch Products
There are currently 4 FDA-approved hydroxyethyl starch products on the market.
Vonvendi Under Review for Prophylactic Use in von Willebrand Disease
The sBLA submission is supported by data from a phase 3 study that assessed the efficacy and safety of prophylactic treatment with Vonvendi in adults with severe VWD over a period of 12 months.
Oral, IV Tranexamic Acid Compared for Joint Replacement Surgery
Interim results of a randomized study indicate that oral and IV TXA are equally effective in reducing perioperative blood loss
BeneFIX Label Updated to Remove Routine Prophylaxis in Children With Hemophilia B
The Agency stated that it “erred in approving the indication for routine prophylaxis in children with hemophilia B” due to the Orphan Drug exclusivity.
Anavip Approval Expanded to Include Copperhead, Cottonmouth/Water Moccasin Envenomations
Anavip contains venom-specific F(ab’)2 fragments of immunoglobulin G that bind and neutralize venom toxins.
Pediatric Data Added to Octaplas, Fibryga Labeling
The updated labeling for Octaplas and fibryga includes new pediatric data.
Antidepressants Not Tied to Increased Intracerebral Hemorrhage Risk
Selective serotonin reuptake inhibitors are not associated with higher risk for intracerebral hemorrhage
EndoClot PHS Approved to Control Bleeding During GI Procedures
EndoClot PHS is a single-use device consisting of a starch-based powder hemostat to control bleeding in the GI tract.
Patient With Gaucher Disease and ITP Effectively Treated With Eltrombopag
The patient, who was initially diagnosed with Gaucher disease type 1 during her first pregnancy 20 years prior, presented with bleeding, hematomas, and thrombocytopenia, in addition to hepatomegaly, splenomegaly, and bone marrow infiltration.
