An Evaluation of the Biological Response to Fraxiparine, (A Low Molecular Weight Heparin) in the Healthy Individual

Abstract

The tolerance of a low molecular weight heparin (Fraxiparine, Choay, Paris, France) in normal individuals was determined using a two part investigation. Study 1 consisted of administering escalating doses of Fraxiparine in a single blinded, placebo controlled, rising dose tolerance evaluation. The daily doses tested were 3750 U AXA IC, 7500 U AXa IC, 11250 U AXa IC, 15000 U AXa IC, and 22500 U AXa IC Fraxiparine subcutaneously for 5 consecutive days. In study 2, we compared the tolerance of unfractionated heparin (UH) administered as 5000 IU every 8 hours, to that of 7500 U AXa IC/day or 15000 U AXa IC/day of Fraxiparine administered once daily. Our results indicated very good tolerance to this low molecular weight heparin (LMWH) at doses up to and including 22500 U AXa IC/day. We observed significantly elevated increases in transaminases following LMWH administration. In our second study we observed that the increase in serum transaminases seen after 15000 U AXa IC/day Fraxiparine was without significant difference from that observed following UH (5000 IU every 8 hours). AXa examination revealed an accumulation of AXa effect after 5 days of administration at doses greater than 15000 U AXa IC, and there was good correlation between AXa and APTT at Fraxiparine doses greater than 15000 U AXa IC/day. No thrombocytopenia was associated with Fraxiparine. We conclude that Fraxiparine is relatively well tolerated and shows accumulation after daily dosing with greater than 15000 U AXa IC.

Enoxaparin-Induced Liver Injury: Case Report and Review of the Literature and FDA Adverse Event Reporting System (FAERS)

“…Such direct injury is confirmed by the frequency of enoxaparin-related ALT and AST as shown by Harrill et al, where more than 50 % of healthy subjects started on enoxaparin developed DILI within 1 week and all were affected by day 12 [26]. As the frequency and dosing of enoxaparin increases, so too does the magnitude of aminotransferase elevations [40, 41], raising the possibility of dose-related injury.…”

Bone marrow transplantation and intensive care unit admission: What really matters? *

“…Humidification of inspiratory gases is widely accepted to be an essential practice for patients receiving mechanical ventilation through an endotracheal tube or tracheostomy tube. However, HMEs may substantially increase the instrumental deadspace volume of the patientventilator circuit and both inspiratory and expiratory resistance, at a variable degree, depending on the device's characteristics (12,13). HME are cheap, safe, and easy to use and require neither external power nor water supply as heated hot water humidifiers do.…”

“…Rello et al (12) in a review of outcomes and reimbursement patterns, determined that the development of VAP resulted in nearly $40,000 in excess costs. Rello et al (12) in a review of outcomes and reimbursement patterns, determined that the development of VAP resulted in nearly $40,000 in excess costs.…”

“…Few studies have systematically examined the mechanisms, risk factors, and incidence of infections associated with PACs, which have similar rates of BSI as CVCs (6,7,10,12,13). PAC-related colonization varies from 2 to 20% and depends on duration of catheter placement and criteria for the definition of colonization (6,14,15).…”

The effects of intraperitoneal piroxicam and low molecular weight heparin in prevention of adhesion reformation in rat uterine horn

“…Harris et al [15] reported that, in the rat model, an agent that remained on injured surfaces for at least 36 h after injury appeared to be more effective in reducing adhesion formation than an agent with a shorter residence time. The half-life of LMWH is about 2-4 h [4], but it has a fibrinolytic effect which lasts about 24 h at the application area [10]. One of the studies, which investigated pharmacokinetics of piroxicam, found that piroxicam had a 40.8 h half-life in female rats [22].…”