Brand Name(s):

  • Fragmin®

IMPORTANT WARNING:

[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.

IMPORTANT WARNING

If you have epidural or spinal anesthesia or a spinal puncture while taking a 'blood thinner' such as dalteparin, you are at risk for internal bleeding that could cause you to become paralyzed.

Tell your doctor if you are taking abciximab (ReoPro); anagrelide (Agrylin); other anticoagulants ('blood thinners') such as warfarin (Coumadin); aspirin, ibuprofen (Advil, Motrin, or Nuprin), indomethacin (Indocin), ketoprofen (Actron, Orudis), naproxen (Aleve, Anaprox, Naprosyn), or other nonsteroidal anti-inflammatory drugs (NSAIDs); cilostazol (Pletal); clopidogrel (Plavix); dipyridamole (Persantine); eptifibatide (Integrilin); 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 dalteparin.

WHY is this medicine prescribed?

Your doctor has ordered dalteparin sodium, an anticoagulant ('blood thinner'), to prevent harmful blood clots from forming. The drug will be injected under the skin (subcutaneously) once a day. This medication is sometimes prescribed for other uses; ask your doctor or pharmacist for more information.

Your health care provider (doctor, nurse, or pharmacist) may measure the effectiveness and side effects of your treatment using laboratory tests and physical examinations. It is important to keep all appointments with your doctor and the laboratory. The length of treatment depends on how you respond to the medication.

What SPECIAL PRECAUTIONS should I follow?

Before administering dalteparin,

  • tell your doctor and pharmacist if you are allergic to dalteparin, heparin, enoxaparin (Lovenox), 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 or have ever had liver or kidney disease or diabetes.
  • tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking dalteparin, call your doctor.

HOW should this medicine be used?

Before you administer dalteparin, look at the solution closely. It should be clear and free of floating material. Observe the solution container to make sure there are no leaks. Do not use the solution if it is discolored, if it contains particles, or if the container leaks. Use a new solution, but show the damaged one to your health care provider.

It is important that you use your medication exactly as directed. Do not change your dosing schedule without talking to your health care provider.

What SIDE EFFECTS can this medicine cause?

Dalteparin may cause side effects. Tell your health care provider if the following symptom is severe or does not go away:

  • upset stomach

If you experience any of the following symptoms or those listed in the IMPORTANT WARNING section, call your doctor or health care provider immediately:

  • unusual bleeding
  • vomiting or spitting up blood or brown material that resembles coffee grounds
  • bloody or black, tarry stools
  • blood in urine
  • red or dark-brown urine
  • easy bruising
  • excessive menstrual bleeding
  • fever
  • dizziness or lightheadedness

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].

What should I know about STORAGE and DISPOSAL of this medication?

  • Your health care provider will probably give you several days supply of dalteparin at a time. You will be told to store it at room temperature.

Store your medication only as directed. Make sure you understand what you need to store your medication properly.

Keep your supplies in a clean, dry place when you are not using them, and keep all medications and supplies out of reach of children. Your health care provider will tell you how to throw away used needles, syringes, tubing, and containers to avoid accidental injury.

What should I do in case of OVERDOSE?

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.

If you are receiving dalteparin under your skin, you need to know the symptoms of a catheter-related infection (an infection where the needle enters your skin). If you experience any of these effects near the infusion site, tell your health care provider as soon as possible:

  • tenderness
  • warmth
  • irritation
  • drainage
  • redness
  • swelling
  • pain

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.