What illnesses did the FDA approve the new drug Saphris from Schering-Plough to treat?
Aug. 14, 2009 — The FDA has approved a new drug called Saphris to treat schizophrenia and bipolar I disorder in adults. “Mental illnesses like schizophrenia and bipolar disorder can be devastating to patients and families, requiring lifelong treatment and therapy,” Thomas Laughren, MD, director of the division of psychiatry products in the FDA’s Center for Drug Evaluation and Research, says in a news release. “Effective medicines can help people with mental illness live more independent lives,” Laughren says. The FDA notes that the most common symptoms of schizophrenia include hearing voices or seeing things that are not there, having false beliefs (for example, believing that others are controlling thoughts, reading minds, or plotting harm), and being inappropriately suspicious or paranoid. Bipolar I disorder is a chronic, severe, and recurrent psychiatric disorder that causes alternating periods of depression and high, increased activity and restlessness, racing thoughts, fast talki
Saphris has been approved by the U.S. Food and Drug Administration to treat adults with either schizophrenia or bipolar I disorder. Symptoms of schizophrenia may include hearing imagined voices, seeing things that aren’t present, and having thoughts that others are going to do you harm. This can lead to behavior including withdrawal, extreme fear, and violence. People with bipolar I have alternating periods of depression and manic highs. Other symptoms may include restlessness, racing thoughts, and impulsive behavior. Saphris is among a class of drugs called atypical antipsychotics, all of which must be labeled with the FDA’s most serious “black box” warning. The label warns of increased risk of death if the drugs are used by older people with dementia-related psychosis. These drugs aren’t approved for this so-called “off-label” use.
FDA approves Saphris to treat schizophrenia, bipolar disorder www.chinaview.cn 2009-08-15 05:49:52 Print WASHINGTON, Aug. 14 (Xinhua) — The U.S. Food and Drug Administration on Friday approved Saphris tablets (asenapine) to treat adults with schizophrenia, a chronic, severe and disabling brain disorder, and to treat bipolar I disorder in adults, a serious psychiatric disorder that causes shifts in a person’s mood, energy, and ability to function. “Mental illnesses like schizophrenia and bipolar disorder can be devastating to patients and families, requiring lifelong treatment and therapy,” said Thomas Laughren, director of the Division of Psychiatry Products in the FDA’s Center for Drug Evaluation and Research. “Effective medicines can help people with mental illness live more independent lives.” The most common symptoms of schizophrenia include hearing voices, or seeing things that are not there, having false beliefs (for example,
Aug. 14, 2009 — The FDA has approved a new drug called Saphris to treat schizophrenia and bipolar I disorder in adults. “Mental illnesses like schizophrenia and bipolar disorder can be devastating to patients and families, requiring lifelong treatment and therapy,” Thomas Laughren, MD, director of the division of psychiatry products in the FDA’s Center for Drug Evaluation and Research, says in a news release. “Effective medicines can help people with mental illness live more independent lives,” Laughren says. The FDA notes that the most common symptoms of schizophrenia include hearing voices or seeing things that are not there, having false beliefs (for example, believing that others are controlling thoughts, reading minds, or plotting harm), and being inappropriately suspicious or paranoid. Bipolar I disorder is a chronic, severe, and recurrent psychiatric disorder that causes alternating periods of depression and high, increased activity and restlessness, racing thoughts, fast talki
