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Obstetrics and Gynecology Publishes Data From Pivotal Phase 3 LYSTEDA Study
Date:10/6/2010

from binding to fibrin.  This allows the clot to stay in place longer, preserving and stabilizing the fibrin's matrix structure, and helps reduce bleeding.

About LYSTEDA™

LYSTEDA (tranexamic acid) tablets are indicated for the treatment of cyclic heavy menstrual bleeding.  Prior to prescribing LYSTEDA, exclude endometrial pathology that can be associated with heavy menstrual bleeding.  For more information, visit www.lysteda.com.

Important Safety Information

LYSTEDA is contraindicated in women with active thromboembolic disease or a history or intrinsic risk of thrombosis or thromboembolism, including retinal vein or artery occlusion; or known hypersensitivity to tranexamic acid.

Concomitant therapy with hormonal contraceptives may further increase the risk of blood clots, stroke, and myocardial infarction.  Women using hormonal contraception should use LYSTEDA only if there is a strong medical need and the benefit of treatment will outweigh the potential increased risk of a thrombotic event.  In case of severe allergic reaction, discontinue LYSTEDA and seek immediate medical attention.  Visual or ocular adverse effects may occur with LYSTEDA.  Immediately discontinue use if visual or ocular symptoms occur.  Concomitant use of LYSTEDA with Factor IX complex concentrates, anti-inhibitor coagulant concentrates or all-trans retinoic acids (oral tretinoin) may increase risk of thrombosis.  Cerebral edema and cerebral infarction may be caused by use of LYSTEDA in women with subarachnoid hemorrhage.

The most common adverse reactions in clinical trials (> 5%, and more frequent in LYSTEDA subjects compared to placebo subjects) were: headache, sinus and nasal symptoms, back pain, abdominal pain, musculoskeletal pain, joint pain, muscle cramps, migraine, anemia and fatigue.

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