If you are receiving epidural or spinal anesthesia or undergoing spinal puncture,
and taking LOVENOX® (enoxaparin sodium injection), you may be at increased risk
of developing a blood clot in or around the spine, which can result in long-term
paralysis. Your risk may be further increased if you:
- Take nonsteroidal anti-inflammatory drugs (NSAIDs), platelet inhibitors, or
other anticoagulants, such as aspirin or blood thinners
- Have an indwelling epidural catheter
- Have a history of spinal trauma, or repeated spinal anesthesia or punctures
- Have a history of spinal deformities or spinal surgery
It is important to contact your doctor immediately if you experience symptoms such
as tingling, numbness (especially in the lower limbs), and muscular weakness.
LOVENOX® should not be used in patients who are actively bleeding or who have
a low count of blood cells called platelets, which aid in clotting. This is a condition
called "thrombocytopenia." LOVENOX® also should not be used in patients who
are allergic or sensitive to LOVENOX® or enoxaparin, heparin, or pork products.
LOVENOX® must be used with care in patients who have any of the following: problems
with clotting, uncontrolled high blood pressure, a recent ulcer, impaired vision
due to diabetes, kidney problems, and excessive bleeding. Pregnant women with mechanical
prosthetic (artificial) heart valves may be at higher risk for blood clots. These
patients who are treated with LOVENOX® must be carefully monitored by their
doctor.
Some patients on LOVENOX® can experience drops in their platelet counts, a condition
called "thrombocytopenia." Also, a serious but rare condition called "heparin-induced
thrombocytopenia" can occur with LOVENOX®. If you have had this condition, you
must notify your healthcare professional.
LOVENOX® alters the blood’s ability to clot. Excessive bleeding (hemorrhage),
leading to death, has occurred with LOVENOX®. Bleeding can occur at any site
with LOVENOX® use. The use of aspirin and other NSAIDs may enhance the risk
of excessive bleeding. Be sure to tell all your doctors and dentist about all of
the medications you are taking, including those you are taking without a prescription,
such as aspirin or other NSAIDs. Also be sure to tell your doctor or dentist you
are taking LOVENOX® before any surgery is scheduled and before any new drug
is taken.
All patients should be carefully monitored by their doctor while taking LOVENOX®.
Your doctor is likely to obtain blood tests that measure your blood count and check
for signs of hidden bleeding while you are on LOVENOX®.
You should call your doctor immediately if you notice any of the following: unusual
bleeding or bleeding that lasts a long time, unusual bruising, signs of thrombocytopenia
(such as a rash or dark spots under the skin), tingling or numbness (especially
in the lower limbs), and muscular weakness.
The most common side effects from the use of LOVENOX® are mild pain, irritation,
bruising, or redness of the skin at the site of injection. Other common side effects
include bleeding, anemia, diarrhea, and nausea.
Do not stop taking LOVENOX® without first talking to the doctor who prescribed
it for you.
For specific questions about your health, you should always consult your doctor
or a qualified healthcare professional who is responsible for your care.
For more information, call sanofi-aventis U.S. Medical Information Services at 1-800-633-1610.
Please see Full Prescribing Information, including boxed
WARNING, for additional important information.