Bleeding Disorders

Antidepressants and Bleeding Risk: What's the Link?

By August 08, 2018

Results showed an increased risk of bleeding with SRIs by 1.16-2.36 times with an even higher 3.17- to 10.9-fold risk with concomitant NSAIDs.

Mulpleta Approved for Thrombocytopenia in Patients With Chronic Liver Disease

By July 31, 2018

The approval was based on data from 2 randomized, double-blind, placebo-controlled trials (L-PLUS 1 [N=97] and L-PLUS 2 [N=215]) involving patients with chronic liver disease who were undergoing an invasive procedure and had a platelet count <50 x 109/L.

Most Bleeding Events in Non-CVD Patients Are GI-Related

June 28, 2018

The risk of a nonfatal GI bleeding event was 2.19 per 1,000 person-years in the baseline cohort, 1.77 in the non-high-risk cohort, and 1.61 in the nonmedication cohort.

Clotting Time in Transfemoral PCI Linked to Bleeding Risk

June 27, 2018

Researchers related maximal ACT to the risk of major bleeding in 14,634 patients undergoing TR or TF PCI with unfractionated heparin monotherapy.

Isolated mild/moderate thrombocytopenia may not require intervention

June 11, 2018

In a review of children who presented to a specialist hematology clinic with isolated mild or moderate low platelet counts, though causes were variable, most required no interventions.

Doptelet Now Available for Thrombocytopenia in Chronic Liver Disease

By May 31, 2018

The drug works by stimulating the proliferation and differentiation of megakaryocytes from bone marrow progenitor cells resulting in an increased production of platelets.

Larger Vial Size Approved for Hemophilia B Treatment Idelvion

By May 31, 2018

The new 3500 IU vial size will help shorten the reconstitution time needed to prepare multiple vials for a similar dose.

Tavalisse Now Available for Chronic Immune Thrombocytopenia

By May 29, 2018

Treatment with Tavalisse should be discontinued after 12 weeks if the platelet count does not increase to a level sufficient to avoid clinically important bleeding.

Extended INR Test Intervals Safe for Warfarin-Treated Patients

May 23, 2018

Similar number of out-of-range next INR values for patients with, without extended testing interval

Doptelet Approved for Chronic Liver Disease Patients With Thrombocytopenia

By May 21, 2018

The approval of Doptelet was based on results from the ADAPT-1 (N=231) and ADAPT-2 trials (N=204), 2 identically-designed multicenter, randomized, double-blind, placebo-controlled studies.

First Generic Alternative for Mephyton Now Available

By May 15, 2018

Amneal's generic product is available in a 5mg strength tablet supplied in 100-count bottles.

FDA Approves Hemospray to Treat Non-Variceal GI Bleeds

By May 09, 2018

The product is a single-use device that delivers hemostatic powder through the channel of an endoscope.

Andexxa Approved for Reversing Anticoagulant Activity of Rivaroxaban, Apixaban

By May 04, 2018

Andexxa, a recombinant modified human Factor Xa (FXa) protein, was approved under the FDA's Accelerated Approval pathway.

Gene Therapy Looks Promising for Transfusion-Dependent β-Thalassemia

By April 19, 2018

The safety and efficacy of LentiGlobin were evaluated in 2 independent 2-year clinical studies: HGB-204 (Northstar, N=18), an open-label, single-dose, nonrandomized, multicenter Phase 1/2 study in patients with TDT, and HGB-205, an ongoing open-label, single-dose, nonrandomized, single-center Phase 1/2 study in patients with TDT and severe sickle cell disease.

First-in-Class Treatment Approved for Chronic Immune Thrombocytopenia

By April 18, 2018

Tavalisse is an oral spleen tyrosine kinase (SYK) inhibitor.

Hemlibra Gets Breakthrough Tx Status for Hemophilia A Without Inhibitors

By April 18, 2018

The trial enrolled 152 patients with hemophilia A who were previously treated, either on-demand or as prophylaxis, with factor VIII therapy.

Praxbind Gains Full FDA Approval as Pradaxa Reversal Agent

By April 17, 2018

Complete reversal was seen within 4 hours in the majority of patients, as measured by ecarin clotting time (ECT 82%) or diluted thrombin time (dTT 99%). In addition, there was a low late of thrombotic events and no new safety events were reported.

Vonvendi Approved for Peri-Operative Management of Bleeding in VWD Patients

By April 17, 2018

Safety and efficacy of Vonvendi with or without recombinant factor VIII (FVIII) treatment in elective surgical procedures in patients aged ≥18 years diagnosed with severe von Willebrand disease, was established in the Phase 3 trial.

Certain Lots of Kcentra Recalled Due to Potential Risk of Vial Breakage

By April 06, 2018

The recall notification is due to a potential risk of breakage of the glass vials during transport because of a change in the secondary packaging configuration.

Comparative Safety of NSAIDs Among Clopidogrel Users Investigated

By March 15, 2018

Using Medicaid claims from 5 states (1999-2010) and Medicare claims for dual-enrollees, study authors analyzed the first concomitant use of clopidogrel and 1 of 10 selected NSAIDs (ibuprofen, celecoxib, naproxen, rofecoxib, meloxicam, diclofenac, indomethacin, valdecoxib, nabumetone, etodolac) after a 1-year baseline period.

Interim Data Show Andexanet Alfa Rapidly Reverses Anti-Factor Xa Activity

By March 13, 2018

ANNEXA-4 is a global, single-arm, open-label clinical trial designed to evaluate andexanet alfa in patients who present with an acute major bleed while receiving apixaban, rivaroxaban, edoxaban or enoxaparin.

Pharmacokinetic Dosing Software for Hemophilia A Treatment Now Available

By March 05, 2018

The myPKFiT software can be used to generate Advate dosage amount and frequency recommendations for routine prophylaxis for an individual patient 16yrs of age and older and body weight of 45kg or greater.

BLA for Extended Half-Life Factor VIII Hemophilia A Tx Filed With FDA

By February 27, 2018

N8-GP (turoctocog alfa pegol) is a glycopegylated form of turoctocog alfa designed for prolonged half-life.

Lusutrombopag Under Priority Review for Thrombocytopenia in Liver Disease

By February 26, 2018

The primary endpoint was the number of patients who required no platelet transfusion priory to primary invasive procedure and no rescue therapy for bleeding for 7 days post-procedure.

Rebinyn Now Available for the Treatment of Hemophilia B

By February 08, 2018

Rebinyn, a recombinant DNA-derived coagulation Factor IX concentrate with an extended half-life, was approved by the Food and Drug Administration (FDA) in May 2017.

Results Released in Multi-Year IV Bevacizumab Study for HHT-Related Bleeding

February 05, 2018

After completion of the initial bevacizumab treatment cycle, there was a significant reduction in epistaxis severity scores and RBC transfusion requirements.

FDA Lifts Hold on Potential Hemophilia Treatment

By December 15, 2017

Fitusiran, an RNAi therapeutic targeting antithrombin (AT), is designed to lower levels of AT in order to further sufficient thrombin generation to restore hemostasis and prevent bleeding.

Gene Therapy Shows Promise in Factor IX Coagulant Activity for Hemophilia B

December 07, 2017

In all participants, vector-derived factor IX coagulant activity was sustained, with a mean steady-state factor IX coagulant activity of 33.7 ± 18.5%.

ACC: New Guidance on Managing Bleeding in Patients on Oral Anticoagulants

December 04, 2017

At each step, patient specific factors should be considered.

Hemophilic Arthropathy Treatment Gets Orphan Drug Designation

By November 27, 2017

TRM-201 (rofecoxib) is a highly potent COX-2 selective non-steroidal anti-inflammatory drug (NSAID) with a well-established efficacy profile.