FDA
TALK PAPER

Food and Drug Administration
U.S. Department of Health and Human Services
Public Health Service 5600 Fishers Lane Rockville, MD 20857
FDA Talk Papers are prepared by the Press Office to guide FDA personnel in responding with consistency and accuracy to questions from the public on subjects of current interest. Talk Papers are subject to change as more information becomes available. 
 
T97-63                      Print Media:         301-827-6242
Dec. 15, 1997               
                            Consumer Inquiries:  800-532-4440

HEALTH ADVISORY FOR CERTAIN ANTICOAGULANT DRUGS (LOW MOLECULAR WEIGHT HEPARINS AND HEPARINOIDS)

The FDA is alerting doctors about a serious safety problem associated with the use of certain anticoagulant drugs used in patients undergoing certain types of surgery to prevent complications from blood clots that can form in the deep leg veins.

The drugs -- low molecular weight heparins and a heparinoid marketed as Lovenox, Fragmin, Normiflo, and Orgaran -- when used concurrently with spinal or epidural anesthesia, or spinal puncture may cause bleeding or hematomas (collection of blood) within the spinal column. When bleeding occurs in the spinal column, increased pressure on the spinal cord may result in permanent paralysis if not detected and treated immediately.

Because this may be a preventable problem, FDA is advising doctors to carefully monitor patients receiving low molecular weight heparins or heparinoids for possible spinal or epidural bleeding.

The risk for bleeding or hematomas is increased by use of catheters placed in the spinal canal to administer pain medication or by the use of other drugs that can affect blood clotting such as non steroidal anti-inflammatory drugs (NSAID's), platelet inhibitors, or other anticoagulants. The risk of adverse effects also appears to be increased by traumatic or repeated spinal or epidural punctures.

FDA's alert was prompted by more than 30 reports, received as of November l997, of patients who developed bleeding within the spinal column, some of which resulted in prolonged or permanent paralysis. These reports were associated with Lovenox used in conjunction with spinal or epidural anesthesia or spinal puncture.

To provide additional information on the safe use of these drugs, FDA has requested that the manufacturers add a boxed warning to the labeling discussing the risk of spinal or epidural hematomas and the importance of monitoring patients for signs or symptoms of neurologic injury.

Health care professionals should report any serious adverse events, including cases of epidural or spinal hematomas, occurring with the use of low molecular weight heparin, heparinoids, or other anticoagulants to the FDA's MEDWATCH program at 1-800-FDA-1088/fax 1-800-FDA-0178; or to the respective pharmaceutical manufacturers:

The public health advisory is being sent to general and orthopedic surgeons, anesthesiologists, pain management specialists, nurses, hematologists and other physician groups.

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