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[Best Syndication News] The US Food and Drug Administration (FDA) gave their approval for Saphris tablets (asenapine) for the treatment of adults with schizophrenia and bipolar I disorder.

Schizophrenia is a chronic and severely disabling brain disorder that can have symptoms of hearing voices and seeing things that are not there. To have false beliefs, to be inappropriately suspicious or paranoid. The person with this condition could be fearful, withdrawal from society, become agitated, or even violent.

Bipolar 1 disorder is also a chronic, severe, and recurring condition that alternates from bouts with depression to super high levels of exuberance, and having racing thoughts, talking fast, impulsive behavior and restlessness. They also may not sleep during the highs.

While the FDA did approve the Saphris medication, they issued a box warning of an increase risk of death associated with off-lable use of the drug being used for older people with dementia-related psychosis. Saphris was not approved by the FDA for treating those patients with the drug.

Saphris was studied in three short-term placebo-controlled as well as active-drug controlled clinical trials. In two the trial Saphris was shown to be beneficial. The side effects with patients being treated for schizophrenia were the inability to remain still, a decreased oral sensitivity and drowsiness.

The biopolar patients treated with Saphris reported side effects of drowsiness, dizziness, movement disorders along with weight increase.

The manufacturer of Saphris is Schering-Plough, Kenilworth, N.J.

By: Marlene Donor