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| |  Lovenox Cleared By FDA To Prevent Blood Clots In Abdominal Surgery COLLEGEVILLE, Pa., May 12, 1997 -- Rhone-Poulenc Rorer Inc. announced today that Lovenox(R) (enoxaparin sodium) Injection was cleared by the U.S. Food and Drug Administration (FDA) for the prevention of deep vein thrombosis (DVT) which may lead to pulmonary embolism (blood clots in the lung) in patients undergoing abdominal surgery who are at risk for thromboembolic complications. Patients at risk include those who are over 40 years of age, obese, undergoing surgery with general anesthesia longer than 30 minutes, or who have additional risk factors such as a malignant tumor or a history of deep vein thrombosis or pulmonary embolism. The FDA's action was based on pivotal trials in patients undergoing elective cancer surgery of the gastrointestinal, urological or gynecological tract and those undergoing colorectal surgery. "For physicians who use standard heparin, the availability of enoxaparin for use in abdominal surgery is an important new treatment option," said Joseph Caprini, MD, professor of surgery at Northwestern University Medical School, director of surgical research at Evanston Hospital, and a practicing general surgeon. "Overall, this compound is certainly as effective as standard heparin, plus it has the distinct advantage of once-daily dosing and eliminates the need for frequent laboratory testing." Deep vein thrombosis is the formation of blood clots which may lead to pulmonary embolism. Pulmonary embolism occurs when a clot circulates and lodges in the lungs, and can cause sudden death. Venous thromboembolic disease is responsible for more than 400,000 hospitalizations and up to 200,000 deaths each year in the U.S. Lovenox is now the only low-molecular-weight heparin cleared in the U.S. for the prevention of deep vein thrombosis in hip and knee replacement and abdominal surgery. Because of its unique pharmacological properties and predictable anticoagulant response, Lovenox eliminates the need for routine monitoring of coagulation times and is administered without adjustment for body weight. However, periodic CBCs (complete blood count), stool occult blood tests and In patients undergoing abdominal surgery, the recommended dose of Lovenox is 40 mg once daily administered by subcutaneous injection with an initial dose two hours before surgery. The usual duration of administration is seven to 10 days; up to 12days administration has been well tolerated in clinical trials. "Recent studies emphasize the importance of thrombosis prophylaxis following hospital discharge," said Dr. Caprini. "Enoxaparin maintains efficacy while providing a simple approach for the patient and healthcare professionals." Enoxaparin sodium, a unique chemical entity in a distinct class of antithrombotic agents known as low-molecular-weight heparins, is obtained by alkaline degradation of heparin benzyl ester and is about one-third the molecular size of standard heparin.
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