• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Safety

  • Print
  • Share
  • E-mail

Arixtra, Fragmin, Innohep, and Lovenox injection

  • Arixtra (fondaparinux sodium) Solution for subcutaneous injection
  • Fragmin (dalteparin sodium injection) for Subcutaneous Use - (label converted to new PLR format additional changes reflected in label)
  • Innohep (tinzaparin sodium) injection
  • Lovenox (enoxaparin sodium) injection for subcutaneous and intravenous use

 

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – December 2009

 

Summary View

 

BOXED WARNING

Revised

WARNING: SPINAL/EPIDURAL HEMATOMAS
  • Epidural or spinal hematomas may occur in patients who are anticoagulated with low molecular weight heparins (LMWH) or heparinoids and are receiving neuraxial anesthesia or undergoing spinal puncture. These hematomas may result in long-term or permanent paralysis. Consider these risks when scheduling patients for spinal procedures. Factors that can increase the risk of developing epidural or spinal hematomas in these patients include:
    • Use of indwelling epidural catheters
    • Concomitant use of other drugs that affect hemostasis, such as non-steroidal anti-inflammatory drugs (NSAIDs), platelet inhibitors, other anticoagulants.
    • A history of traumatic or repeated epidural or spinal punctures
    • A history of spinal deformity or spinal surgery
  • Monitor patients frequently for signs and symptoms of neurological impairment. If neurological compromise is noted, urgent treatment is necessary.
  • Consider the benefits and risks before neuraxial intervention in patients anticoagulated or to be anticoagulated for thromboprophylaxis