[Posted 11/06/2013]ISSUE:The U.S. Food and Drug Administration (FDA) is recommending that health care professionals carefully consider the timing of spinal catheter placement and removal in patients taking anticoagulant drugs, such as enoxaparin, and delay dosing of anticoagulant medications for some time interval after catheter removal to decrease the risk of spinal column bleeding and subsequent paralysis after spinal injections, including epidural procedures and lumbar punctures. These new timing recommendations, which can decrease the risk of epidural or spinal hematoma, will be added to the labels of anticoagulant drugs known as low molecular weight heparins, including Lovenox and generic enoxaparin products and similar products.
BACKGROUND:Epidural or spinal hematomas are a known risk of enoxaparin in the setting of spinal procedures and are already described in the Boxed Warning and the Warnings and Precautions sections of the labels for Lovenox and generic enoxaparin products. However, these serious adverse events continue to occur (see Data Summary). To address this safety concern, FDA worked with the manufacturer of Lovenox, Sanofi-Aventis, to further evaluate this risk and to update the Warnings and Precautions section of the Lovenox label with these additional timing recommendations. The labels for generic enoxaparin products will also be revised accordingly, as will those of other low molecular weight heparin-type products.
It is important to note that all anticoagulants carry the risk of causing spinal bleeding when used in conjunction with epidural/spinal anesthesia or spinal puncture. We are continuing to evaluate the safety of other anticoagulants to determine if additional label changes are needed.
RECOMMENDATION:Health care professionals and institutions involved in performing spinal/epidural anesthesia or spinal punctures should determine, as part of a preprocedure checklist, whether a patient is receiving anticoagulants and identify the appropriate timing of enoxaparin dosing in relation to catheter placement or removal. To reduce the potential risk of bleeding, consider both the dose and the elimination half-life of the anticoagulant:
- For enoxaparin, placement or removal of a spinal catheter should be delayed for at least 12 hours after administration of prophylactic doses such as those used for prevention of deep vein thrombosis. Longer delays (24 hours) are appropriate to consider for patients receiving higher therapeutic doses of enoxaparin (1 mg/kg twice daily or 1.5 mg/kg once daily).
- A postprocedure dose of enoxaparin should usually be given no sooner than 4 hours after catheter removal.
- In all cases, a benefit-risk assessment should consider both the risk for thrombosis and the risk for bleeding in the context of the procedure and patient risk factors.
For more information visit the FDA website at: Web Siteand Web Site.
If you have epidural or spinal anesthesia or a spinal puncture while taking a 'blood thinner' such as enoxaparin, you are at risk for having a blood clot form in or around your spine that could cause you to become paralyzed. Tell your doctor if you are taking other anticoagulants ('blood thinners') such as warfarin (Coumadin), anagrelide (Agrylin), aspirin or nonsteroidal anti-inflammatory drugs (ibuprofen, naproxen), cilostazol (Pletal), clopidogrel (Plavix), dipyridamole (Persantine), eptifibatide (Integrilin), prasugrel (Effient), sulfinpyrazone (Anturane), ticlopidine (Ticlid), and tirofiban (Aggrastat).
If you experience any of the following symptoms, call your doctor immediately: numbness, tingling, leg weakness or paralysis, and loss of control over your bladder or bowels.
Talk to your doctor about the risk of taking enoxaparin. Keep all appointments with your doctor.
Enoxaparin is used to prevent blood clots in the leg in patients who are on bedrest or who are having hip replacement, knee replacement, or stomach surgery. It is used in combination with aspirin to prevent complications from angina (chest pain) and heart attacks. It is also used in combination with warfarin to treat blood clots in the leg. Enoxaparin is in a class of medications called low molecular weight heparins. It works by stopping the formation of substances that cause clots.
Enoxaparin comes as an injection in a syringe to be injected just under the skin (subcutaneously) but not into your muscle. It is usually given twice a day. You will probably begin using the drug while you are in the hospital and then use it for a total of 10–14 days. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Use enoxaparin exactly as directed. Do not inject more or less of it or inject it more often than prescribed by your doctor.
Continue to use enoxaparin even if you feel well. Do not stop taking enoxaparin without talking to your doctor.
Your healthcare provider will teach you how to give yourself the shot or arrangements will be made for someone else to give you the shot. Enoxaparin is usually injected in the stomach area. You must use a different area of the stomach each time you give the shot. If you have questions about where to give the shot, ask your healthcare provider. Each syringe has enough drug in it for one shot. Do not use the syringe and needle more than one time. Your doctor, pharmacist, or health care provider will tell you how to throw away used needles and syringes to avoid accidental injury. Keep syringes and needles out of reach of children.
To inject enoxaparin, follow these instructions:
- Wash your hands and the area of skin where you will give the shot.
- Look at the syringe to be sure the drug is clear and colorless or pale yellow.
- Take the cap off the needle. Do not push any air or drug out of the syringe before giving the shot unless your healthcare provider tells you to.
- Lie down and pinch a fold of skin between your finger and thumb. Push the entire needle into the skin and then press down on the syringe plunger to inject the drug. Hold onto the skin the entire time you give the shot. Do not rub the site after you give the shot.
This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.
Before taking enoxaparin,
- tell your doctor and pharmacist if you are allergic to enoxaparin, heparin, any other drugs, or pork products.
- tell your doctor and pharmacist what prescription and nonprescription medications you are taking, especially those listed in the IMPORTANT WARNING section and vitamins.
- tell your doctor if you have an artificial heart valve and if you have or have ever had kidney disease, an infection in your heart, a stroke, a bleeding disorder, ulcers, or a low platelet count.
- tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking enoxaparin, call your doctor.
- if you are having surgery, including dental surgery, tell the doctor or dentist that you are taking enoxaparin.
Inject the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not inject a double dose to make up for a missed one.
Enoxaparin may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:
- upset stomach
- irritation or burning at site of injection
If you experience any of the following symptoms or those listed in the IMPORTANT WARNING section, call your doctor immediately:
- unusual bleeding or bruising
- black or bloody stools
- blood in urine
- swollen ankles and/or feet
If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online [at Web Site] or by phone [1-800-332-1088].
Keep this medication out of reach of children. Store the syringes at room temperature and away from excess heat and moisture (not in the bathroom). Do not use the syringe if it leaks or if the fluid is dark or contains particles. Throw away any medication that is outdated or no longer needed. Talk to your pharmacist about the proper disposal of your medication.
In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.
Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests to monitor your enoxaparin therapy.
Enoxaparin prevents blood from clotting so it may take longer than usual for you to stop bleeding if you are cut or injured. Avoid activities that have a high risk of causing injury. Call your doctor if bleeding is unusual.
Do not let anyone else use your medication. Your prescription is probably not refillable.
It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.
AHFS® Consumer Medication Information. © Copyright, The American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland. All Rights Reserved. Duplication for commercial use must be authorized by ASHP.
Selected Revisions: November 15, 2013.