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#1
Sep 17, 2015, 06:01 PM
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The US Food and Drug Administration (FDA) has approved a new medication for the treatment of schizophrenia and bipolar disorder in adults.
The FDA's approval of cariprazine (Vraylar, Forest Laboratories, Inc), an oral, once-daily atypical antipsychotic, is based on results of three 6-week clinical trials involving 1754 participants. According to the FDA, in each of the trials, the drug was shown to reduce symptoms of schizophrenia compared with placebo. Similarly, three 6-week trials involving 1037 participants showed that the drug reduced symptoms of bipolar disorder. As weith other drugs in its class, cariprazine comes with a boxed warning advising healthcare professionals about an increased risk for death in older patients with dementia-related psychosis. The most common side effects reported by participants receiving cariprazine in the clinical trials for schizophrenia were extrapyramidal symptoms, such as tremor, slurred speech, and involuntary muscle movements. The most common side effects reported by trial participants receiving cariprazine for bipolar disorder were extrapyramidal symptoms, akathisia, dyspepsia, vomiting, somnolence, and restlessness. "Schizophrenia and bipolar disorder can be disabling and can greatly interfere with day-to-day activities," Mitchell Mathis, MD, director of the Division of Psychiatry Products in the FDA's Center for Drug Evaluation and Research, said in a statement. "It is important to have a variety of treatment options available to patients with mental illnesses so that treatment plans can be tailored to meet a patient's individual needs," he added. |
 BeyondtheRainbow, secretgalaxy
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#2
Sep 17, 2015, 08:49 PM
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Wow. Now if only I could make it until the stuff is available and my dr had access to samples I'd have something else to try. Too bad the timing isn't so good; it will probably be a few months before those things happen.
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Bipolar 1, PTSD, GAD, OCD. Clozapine 250 mg, Emsam 12 mg/day patch, topamax 25 mg, ,Gabapentin 1600 mg & 100-2 PRN,. 2.5 mg clonazepam., 75 mg Seroquel and 12.5 mg PRNx2 daily |
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#3
Sep 17, 2015, 09:22 PM
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Im not impressed or okay with such limited studies.. Seems the FDA is quick to okay psych meds faster and faster.. If I was into conspiracy theories I would make a hint of population control...
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Helping others gets me out of my own head ~ |
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#4
Sep 17, 2015, 09:24 PM
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Quote:
Solvent Green my dear .... 
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| ~Christina
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#5
Sep 17, 2015, 09:33 PM
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 uh hu
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Helping others gets me out of my own head ~ |
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