Lovenox (enoxaparin sodium) Dear Healthcare Professional Letter Feb 2002
This is the retyped text of a letter from Aventis Laboratories. Contact the company for a copy of any referenced enclosures.
IMPORTANT PRESCRIBING INFORMATION
Dear Health Care Professional:
This letter is to inform you about recent changes to the Lovenox (enoxaparin sodium) Injection product labeling. Please note the following additions to the WARNINGS and PRECAUTIONS sections of the Lovenox prescribing information.
In the WARNINGS section the following subsection has been added:
Prosthetic Heart Valves: The use of Lovenox Injection is not recommended for thromboprophylaxis in patients with prosthetic heart valves. Cases of prosthetic heart valve thrombosis have been reported in patients with prosthetic valves who have received enoxaparin for thromboprophylaxis. Some of these cases were pregnant women in whom thrombosis led to maternal deaths and fetal deaths. Pregnant women with prosthetic heart valves may be at higher risk for thromboembolism (see PRECAUTIONS: Pregnancy).
In the PRECAUTIONS section, Pregnancy subsection a new paragraph has been added to the Teratogenic Effects subsection regarding congenital anomalies:
There have been reports of congenital anomalies in infants born to women who received enoxaparin during pregnancy including cerebral anomalies, limb anomalies, hypospadias, peripheral vascular malformation, fibrotic dysplasia, and cardiac defect. A cause and effect relationship has not been established nor has the incidence been shown to be higher than in the general population.
The Non-teratogenic Effects subsection has been revised:
Non-teratogenic Effects: There have been post-marketing reports of fetal death when pregnant women received Lovenox Injection. Causality for these cases has not been determined. Pregnant women receiving anti-coagulants, including enoxaparin, are at increased risk for bleeding. Hemorrhage can occur at any site and may lead to death of mother and/or fetus. Pregnant women receiving enoxaparin should be carefully monitored. Pregnant women and women of child-bearing potential should be apprised of the potential hazard to the fetus and the mother if enoxaparin is administered during pregnancy.
In a clinical study of pregnant women with prosthetic heart valves given enoxaparin (l mg/kg bid) to reduce the risk of thromboembolism, 2 of 7 women developed clots resulting in blockage of the valve and leading to maternal and fetal death. There are postmarketing reports of prosthetic valve thrombosis in pregnant women with prosthetic heart valves while receiving enoxaparin for thromboprophylaxis. These events resulted in maternal death or surgical interventions. The use of Lovenox Injection is not recommended for thromboprophylaxis in pregnant women with prosthetic heart valves (see WARNINGS: Prosthetic Heart Valves).
We hope this information will be helpful to you in caring for your patients. Please see the enclosed full prescribing information. For more information about Lovenox or the updated prescribing information please contact your Aventis Pharmaceuticals sales representative or Aventis Pharmaceuticals Medical Informatics Department at 1-800-633-1610.
Please report all adverse events to Aventis Pharmaceuticals Product Surveillance at 1-800--633-1610 or to the FDA MedWatch program: by phone at 1-800-FDA-1088; by Fax at 1-800-FDA-0178; via the MedWatch Website at www.fda.gov/medwatch; or by mail (using postage paid form) at MedWatch, 5600 Fishers Lane, Rockville, MD 20857-9787.
Francois Nader, MD
Senior Vice President
North American Regulatory and Medical Affairs
300 Somerset Corporate Blvd
Bridgewater, NJ 08807-2854