Medication Information - Antithrombotics
A new Factor Xa inhibitor is in development. It looks promising up through Phase II testing. In a safety study, oral BAY 59-7939 in single doses up to 80 mg was safe and well tolerated and was not associated with an increased risk of bleeding compared with placebo. Pharmacodynamic effects (inhibition of factor Xa activity, prothrombin time, activated partial thromboplastin time, and Hep Test) and plasma concentration profiles were dose-dependent. Maximum inhibition of factor Xa activity was achieved 1 to 4 hours after administration of BAY 59-7939 and ranged from 20% to 61% for the 5- to 80-mg doses. Last updated April 8, 2007
The American Journal of Medicine. Volume 120, Issue 1 , January 2007, Pages 72-82.e3. Conclusion: Our study shows that LMWH is similar in effectiveness to the usual-care vitamin K antagonist treatment for preventing recurrent venous thromboembolism in a broad spectrum of patients. It causes less harm and enhances the clinicians' therapeutic options for patients with proximal deep vein thrombosis. Our findings reported here suggest the possibility of a broader role for long-term LMWH in selected patients.
Alternative Pharmacologic Agents for Prophylactic & Therapeutic Anticoagulation in Patients with Heparin-induced Thrombocytopenia
Links to heparin sites.
Prescribing Information - April 2007
Thrombosis Journal 2005, 3:14 doi:10.1186/1477-9560-3-14
Annals of Internal Medicine; 15 October 2002, Volune 137, Number 8, Pages 649-659
IT MUST BE NOTED THAT THE US FDA HAS NEVER GIVEN APPROVAL TO USING ANY HEPARIN OR LOW MOLECULAR WEIGHT HEPARIN AS A BRIDGE THERAPY WHEN WARFARIN MUST BE STOPPED. Last reviewed July 8, 2005
Prescribing Information - October 2005
Blood, 1 November 2006, Vol. 108, No. 9, pp. 2884-2885.
Enoxaparin sodium (LMW Heparin). Official manufacturer's site.
This information has been developed and provided by an independent third-party source. Merck & Co., Inc. does not endorse and is not responsible for the accuracy of the content, or for practices or standards of non-Merck sources.
The advantage that is being sought among this class of drugs is lowered bleeding risk compared to warfarin. If this proves true, this class of drugs will be very advantageous. When otamixaban was administered IV to healthy, male subjects, it was found to have rapid plasma distribution and elimination, low intersubject variability and was excreted by both the liver and the kidney. Last updated April 8, 2007
Tinzaparin sodium (LMW Heparin). Official manufacturer's site.
Fondaparinux is a type of "blood thinner" medication (heparinoids) used to help prevent the formation of blood clots following abdominal, hip or knee surgery.
Last Updated: 3/13/2007. Neither low molecular weight heparins (LMWH; in the U.S.: Fragmin┬«, Lovenox┬«, or Innnohep┬«) nor Fondaparinux (=Arixtra┬«) have FDA approval to be used in pregnancy. This reflects that neither one has been tested in any larger trials in pregnant women. Thus, it is not known whether one is more or less effective as a blood thinner during pregnancy than the other, or more or less safe. Both, low molecular weight heparins and Arixtra┬«, are categorized as "class B" drugs during pregnancy, meaning that "animal studies show no risk or adverse fetal effects, but controlled human 1st trimester studies are not available; there is no evidence of 2nd or 3rd trimester risk; fetal harm is possible but unlikely". In pregnant women who need blood thinners, most physicians probably use LMWH and not Arixtra┬«, because LMWHs have been in use much longer and there is much more clinical experience with them during pregnancy. While there are a large number of publications reporting the use of LMWH during pregnancy, for Arixtra┬« there are only a few case reports (references 1-4). Arixtra┬« is, therefore, typically only used in the pregnant woman with a history or heparin allergy, called "HIT" (or heparin induced thrombocytopenia).
enoxaparin sodium injection. Rx only. Rev. (c) 2007
Exanta (ximelagatran) had been touted as the replacement for warfarin. However, an FDA Advisory Committee recommended against approval in September 2004. Since that time, dabigatran etexilate has become the rising star of the oral, direct thrombin inhibitor world. Like ximelagatran, dabigatran etexilate is an orally active prodrug. This means that it is not active in the form that is given by mouth, but it is metabolized to the active form dabigatran. For purposes of this review the drug will be simply referred to as dabigatran. Last updated April 8, 2007
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