HEALTH ADVISORY FOR CERTAIN ANTICOAGULANT DRUGS

[FDA]

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 Broadcast Media: 301-827-3434
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:
* Fragmin (dalteparin sodium injection); Phamacia & Upjohn;
1-800-253-8600 ext 38244.
* Lovenox (enoxaparin sodium) Injection; Rhone-Poulenc Rorer
Pharmaceuticals Inc.; 1-800-340-7502.
* Normiflo (ardeparin sodium) Injection; Wyeth Laboratories Inc.
1-800-934-5556;
* Orgaran (danaparoid sodium) Injection; Organon Inc.;
1-800-631-1253.

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