ClotCare: Blood Clots, Stroke, Heart Attack
Thursday, November 21, 2024
Home   |   DVT/PE   |   Blood Clots   |   Coumadin/Warfarin   |   New Patients   |   Self Testing   |   Email List   |   Donate

Pick a Topic:

Find info on a:

We subscribe to the HONcode principles of the HON Foundation. Click to verify.
ClotCare complies with the HONcode standard for trustworthy health
information:
verify here.

ClotCare is a member of the Coalition to Prevent Deep Vein Thrombosis (DVT Coalition)  ClotCare is a member organization of the Coalition to Prevent Deep Vein Thrombosis. Click here to learn more about the Coalition to Prevent Deep Vein Thrombosis and DVT Awareness Month, which is held each March.

FDA Approves a New Generic Low Molecular Weight Heparin as Equivalent to - and Interchangeable with - Lovenox

Henry I. Bussey, Pharm.D.
July, 2010

Over the objections of several experts and professional organizations involved in anticoagulation and patient safety, the FDA issued a surprising decision today to approve a new low molecular weight heparin (LMWH) product as being the generic equivalent of, and interchangeable with, Lovenox (enoxaparin). Readers can learn more about this decision at fda.gov/Drugs/DrugSafety/
PostmarketDrugSafetyInformationforPatientsandProviders/
ucm220037.htm

ClotCare anticipates posting additional commentary and information on this issue but wanted to get this breaking news out as soon as possible. Much of the controversy on this issue centered around:

  • how different methods used to turn unfractionated hepain (UFH) into a LMWH product can produce different LMWHs with different effects
  • the recent problems with contaminated UFH
  • the complexity of the components of the various LMWHs
  • the multiple actions of the components of the LMWHs
  • the potential for differences in risk of immune-mediated adverse effects

It is entirely feasible, therefore, that different LMWHs produced from different sources of UFH through different production methods may yield products that have different efficacy, safety, and immunogenicity profiles. That is not to say that the new products WILL be different; but rather that the new product has the potential to act differently in ways that could prove harmful to patients. In fact, the new LMWHs could prove to be superior in safety, efficacy, and immunogenicity to the established products; but expert opinion indicates that such differences can not be determined prior to approval in the absence of clinical trials.

Ask a question about blood clots or anticoagulant medications Have questions? Ask ClotCare. Send questions by email to webmaster@clotcare.org.
ClotCare is a 501(c)(3) non-profit organization generously supported by your tax-deductible donations and grants from our industry supporters.
Blood Clot Activities Calendar

New Postings:

Click here to view full list of new postings
ClotCare Home | New Postings | Patient Postings | Clinician Postings | Join Our Email List | Useful Web Links
CE Opportunities | Training Programs | DVT & PE Stories | Editorial Board | Financial Support
About ClotCare | DVT Coalition | Donate to ClotCare | Contact Us
Key topics discussed on ClotCare include: Blood Clots | Deep Vein Thrombosis (DVT) | Pulmonary Embolism (PE) | Atrial Fibrillation (A. Fib or AF) | Heart Attack | Stroke | Transient Ischemic Attack (TIA) | Mini Stroke | Bleeding Complications | Vascular Surgery | Surgical Blood Clot Removal | Warfarin | Coumadin | Lovenox | Low Molecular Weight Heparin (LMWH) | Heparin | Anticoagulants | Plavix | Aspirin | Antiplatelets | Blood Thinners
Copyright 2000-2018 by ClotCare. All rights reserved.
Terms, Conditions, & Privacy | Image Copyright Information
19260 Stone Oak Parkway, Suite 101 | San Antonio, TX 78258 | 210-860-0487
Send comments to webmaster@clotcare.org.
Thursday, November 21, 2024