Lovenox FDA Alerts
The FDA Alert(s) below may be specifically about Lovenox or relate to a group or class of drugs which include Lovenox (enoxaparin).
MedWatch Safety Alerts are distributed by the FDA and published by Drugs.com. Following is a list of possible medication recalls, market withdrawals, alerts and warnings. For the latest FDA MedWatch alerts, go here.
Recent FDA Alert(s) for enoxaparin
Low Molecular Weight Heparins: Drug Safety Communication - Recommendations to Decrease Risk of Spinal Column Bleeding and Paralysis
Nov 6, 2013
Audience: Pharmacy, Cardiology, Anesthesiology
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.
[11/06/2013 - Drug Safety Communication - FDA]
Lovenox (enoxaparin sodium injection)
Aug 17, 2004
Audience: Physicians, pharmacists, and other healthcare providersFDA and Aventis Pharmaceuticals revised the CLINICAL PHARMACOLOGY, PRECAUTIONS, and DOSAGE AND ADMINISTRATION sections of labeling, describing the need for a dosage adjustment for patients with severe renal impairment (creatinine clearance <30mL/min) who have increased exposure to enoxaparin. No specific dosage adjustment is required in patients with mild or moderate renal impairment and in low-weight patients. However, low-weight patients should be observed carefully for signs and symptoms of bleeding.
[March 2004 Letter - Aventis]
[July 2004 Label - Aventis]
Lovenox (enoxaparin sodium)
Apr 3, 2002
Audience: Healthcare ProfessionalsFDA and Aventis strengthened the WARNINGS and PRECAUTIONS sections of the Lovenox prescribing information to inform healthcare professionals that the use of Lovenox Injection is not recommended for thromboprophylaxis in patients with prosthetic heart valves. New postmarketing safety information concerning congenital anomalies and non-teratogenic effects on pregnant women and fetuses are described.
[Feb 28, 2002 Letter - Aventis]
[July, 2001 Revised Label - Aventis] Changes highlighted