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New Label Information Supports Dalteparin in Geriatric Patients

PEAPACK, NJ -- (INTERNET WIRE) -- 04/11/2003 -- Pharmacia Corporation announced that the U.S. Food and Drug Administration (FDA) has approved a supplemental new drug application (sNDA) for additional labeling information supporting the use of FRAGMIN® (dalteparin sodium injection) in geriatric patients. According to the new label, data from clinical studies have not revealed any differences in the efficacy of FRAGMIN among elderly and younger patients.

FRAGMIN, a low-molecular weight heparin (LMWH), was initially approved by the FDA in 1996. It is indicated for the prevention of deep vein thrombosis (potentially life-threatening blood clots in blood vessels) in patients undergoing hip replacement surgery or at-risk patients undergoing abdominal surgery. FRAGMIN also is approved for the prevention of ischemic cardiac complications in unstable angina (constant chest pain) and non-Q wave myocardial infarction (heart attack) when concurrently administered with aspirin.

"Geriatric patients generally are at greater risk for potentially life-threatening blood clots and cardiac complications than younger patients. It is important that they have access to treatments, such as FRAGMIN," said Ellen Gudewill, global vice president, hospital products, global prescription business, Pharmacia Corporation.

Blood clots are a significant health threat for geriatric patients because the risk of developing them increases as people age. In addition, the American Academy of Orthopaedic Surgeons reports that 67 percent of all total hip replacement surgeries are performed on patients aged 65 and older, a procedure that increases this population's risk for clots.[1]

Blood clots affect nearly 2 million patients each year and lead to death in approximately 60,000 to 100,000 of them.[2] Findings from a recent national survey show that 74 percent of Americans are unaware of the condition of deep vein thrombosis, and 95 percent have never discussed clots with their physicians.[3]

The new label information for FRAGMIN also is important because according to the American Heart Association, many cases of unstable angina and myocardial infarction in the United States occur in patients 65 years and older.

The geriatric sNDA was based on a review of FRAGMIN clinical studies and post-marketing reports on the drug's use. The clinical studies involved 2,765 patients who were 65 or older and 897 patients who were 75 or older. Data from these studies and post-marketing reports showed no overall differences in the safety of FRAGMIN when used in elderly patients. Careful attention to dosing intervals and concomitant medications is advised, especially in geriatric patients with low body weight and those with decreased kidney function.

To date, more than 50 million patients worldwide have been treated with FRAGMIN, which is available in 40 countries.

FRAGMIN, like other anticoagulants, should be used with extreme caution in patients who have an increased risk of hemorrhage; bleeding can occur at any site during therapy. An unexpected drop in hematocrit or blood pressure should lead to a search for a bleeding site. Spinal or epidural hematomas can occur with the associated use of low molecular weight heparins or heparinoids and neuraxial (spinal/epidural) anesthesia or spinal puncture, which can result in long-term or permanent paralysis.

The risk of these events is higher with the use of indwelling epidural catheters or concomitant use of additional drugs affecting hemostasis such as NSAIDs. Patients should be frequently monitored for signs and symptoms of neurological impairment.

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