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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.

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