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U.S. Department of Health and Human Services

Safety

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Lovenox (enoxaparin sodium injection) for Subcutaneous and Intravenous Use July 2008


Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) -- July 2008

 

The detailed view includes drug products with safety labeling changes to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, or PATIENT PACKAGE INSERT/MEDICATION GUIDE sections. Deletions or editorial revisions made to these sections are not included in this summary.


Summary View

 

Sections Modified Summary of Changes to Contraindications and Warnings

WARNINGS AND PRECAUTIONS

  • Use of Lovenox with Concomitant Medical Conditions

ADVERSE REACTIONS

  • Postmarketing Experience
    • ...Skin necrosis (occurring at either the injection site or distant from the injection site)...
    • ...Cases of hyperkalemia have been reported. Most of these reports occurred in patients who also had conditions that tend toward the development of hyperkalemia (e.g., renal dysfunction, concomitant potassium-sparing drugs, administration of potassium, hematoma in body tissues)...

USE IN SPECIFIC POPULATIONS

  • Renal Impairment
    • ...In patients with renal failure, treatment with enoxaparin has been associated with the development of hyperkalemia [see Adverse Reactions (6.2)].

WARNINGS AND PRECAUTIONS

Use of Lovenox with Concomitant Medical Conditions

Lovenox should be used with care in patients with a bleeding diathesis, uncontrolled arterial hypertension or a history of recent gastrointestinal ulceration, diabetic retinopathy, renal dysfunction and hemorrhage.