Label Changes for:

Fragmin (dalteparin sodium) injection

October 2010

Changes have been made to the WARNINGS and PRECAUTIONS sections of the safety label.

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – October 2010

 

WARNINGS AND PRECAUTIONS

Increased Risk of Hemorrhage
  • Spinal or epidural hematomas can occur with the associated use of low molecular weight heparins or heparinoids and neuraxial (spinal/epidural) anesthesia or spinal puncture..The risk of these events is higher with the use of post-operative indwelling epidural catheters with the concomitant use of additional drugs affecting hemostasis such as NSAIDs, with traumatic or repeated epidural or spinal puncture, or in patients with a history of spinal surgery or spinal deformity
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