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FDA Approves SAMSCA(TM) (tolvaptan), the First and Only Oral Vasopressin Antagonist to Treat Patients With Clinically Significant Hypervolemic and Euvolemic Hyponatremia
Date:5/21/2009

atients. The severity of symptomatology is associated with the rapidity of onset of hyponatremia: the quicker the onset, the more severe the symptoms. Hyponatremia that develops more slowly may show symptoms such as muscle cramps and headaches; however, more rapidly occurring hyponatremia may cause altered mental status with confusion, coma, and possibly seizures. Patients with chronic hyponatremia do have symptoms such as attention deficits, unsteadiness, gait imbalance, posture impairment and increased falls. Other hyponatremia symptoms may include nausea and vomiting, irritability and weakness. SAMSCA is indicated for the treatment of patients with clinically significant hypervolemic and euvolemic hyponatremia (serum sodium less than 125 mEq/L, or less marked hyponatremia that is symptomatic and has resisted correction with fluid restriction) including patients with heart failure, cirrhosis, and the syndrome of inappropriate anti-diuretic hormone (SIADH). Patients requiring urgent treatment to raise serum sodium to prevent or to treat serious neurological deficits should not be treated with SAMSCA. Additionally, it has not been established that raising serum sodium with SAMSCA provides a symptomatic benefit to patients.

IMPORTANT SAFETY INFORMATION for SAMSCA

SAMSCA should be initiated and re-initiated in patients only in a hospital where serum sodium can be monitored closely. Too rapid correction of hyponatremia (e.g., increase greater than 12 mEq/L/24 hours) can cause osmotic demyelination resulting in dysarthria, mutism, dysphagia, lethargy, affective changes, spastic quadriparesis, seizures, coma and death. In susceptible patients, including those with severe malnutrition, alcoholism or advanced liver disease, slower rates of correction may be advisable.

SAMSCA is contraindicated in the following conditions: Urgent need to raise serum sodium acutely, inability of the patient to
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SOURCE Otsuka Pharmaceutical Co., Ltd.; Otsuka America Pharmaceutical, Inc.; Otsuka Pharmaceutical Development & Commercialization, Inc.
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