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
