Home » Drug Information » FDA-Approved Drugs » 1997
Medical Areas: Cardiology/Vascular Diseases
View By: Year Company Therapeutic Areas Drug Names
Drug Information
The following information is obtained from various newswires, published
medical journal articles, and medical conference presentations.
Company: Wyeth
Approval Status: Approved May 1997
Treatment Area: Deep venous thrombosis
Normiflo (andeparin sodium,)a low molecular weight heparin
cleared for use in prevention of deep venous thrombosis (DVT),
differs from others in its class by allowing the orthopedic surgeon
to determine dosing based on a patient’s weight. The new dosing
method eliminates the need for daily dosage adjustments and routine
coagulation laboratory monitoring. Venous thromboembolic disease
includes DVT, the formation of blood clots following surgery and
its complications such as pulmonary embolism, which can be sudden
and fatal.
In one study, dosing regimens of Normiflo were compared to
warfarin for preventing DVT in patients electing knee replacement
surgery, a procedure that puts patients at high risk of developing
the condition. Normiflo was found to be more effective than
warfarin in preventing venous thromboembolism. Investigators
concluded that ardeparin sodium was significantly more effective
than warfarin and had a comparable safety profile. In another
study, results showed that dosing based on body weight produced
constant plasma antiXa levels. No routine coagulation monitoring is
required during thromboprophylaxes with Normiflo. However,
monitoring of complete blood counts, including platelet counts,
urinalysis, and occult blood in stools, is recommended.
Normiflo should not be used in patients with active major
bleeding, hypersensitivity to the drug, or thombocytopenia
associate with a positive in vitro test for antiplatelet antibodies
in the presence of Normiflo. Patients with a known hypersensitivity
to ardeparin sodium or to pork products should not be treated with
Normiflo. Bleeding can occur at virtually any site. If problematic
bleeding occurs, Normiflo should be discontinued. Patients should
be observed closely for bleeding if Normiflo is administered during
or immediately following diagnostic lumbar puncture, epidural
anesthesia, or spinal anesthesia.
Venous thromboembolic disease is considered to be responsible
for more than 400,000 hospitalizations and up to 200,000 deaths in
the U.S. alone. In the absence of prophylaxis with any agent or
device, DVT is estimated to occur in 40% or 70% of patients
following major orthopedic procedures with death resulting in 1% of
knee replacement patients.