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FDA Orders Updated Label for Lovenox

Destiny Baker3 years ago

The U.S. Food and Drug Administration (FDA) is updating warning labels for the blood thinner Lovenox following continued cases of spinal and epidural bleeding resulting in paralysis.

Lovenox’s New Warning Label

  • Reuters reports that the FDA is updating the warning label for Sanofi’s anticoagulant Lovenox as well as the warning label for the drug’s generic version, enoxaparin.
  • Both Lovenox and its generic counterpart already contain warnings detailing serious risks of developing spinal or epidural bleeds which can result in paralysis, but continued occurrences have led the FDA to add timing recommendations.
  • New warning labels will advise that placement or removal of spinal catheters should not occur until at least 12 hours after a patient receives a dose of Lovenox or enoxaparin– 24 hours for higher doses.
  • The FDA also recommends that physician wait at least four hours after the removal of spinal catheters before treating a patient with Lovenox or enoxaparin.

Lovenox Side Effects

  • According to the article, Sanofi reported 170 instances of patients developing hematomas (spinal and epidural bleeds) between July 20, 1992 and January 31, 2013.
  • Other adverse events reported by include:

    • Thrombocytopenia
    • Hemorrhage
    • Anemia
    • Renal Failure
    • Cardiac Arrest
    • Deep Vein Thrombosis
    • Death
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