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FDA Approves Once-Monthly Abilify Maintena (aripiprazole) for Extended-Release Injectable Suspension for the Treatment of Schizophrenia

Posted 1 Mar 2013 by Drugs.com

TOKYO & COPENHAGEN, Denmark--(BUSINESS WIRE)--Feb 28, 2013 - Otsuka Pharmaceutical Co., Ltd. (Otsuka) and H. Lundbeck A/S (Lundbeck) announced the U.S. Food and Drug Administration (FDA) has approved Abilify Maintena (aripiprazole) for extended- release injectable suspension, an intramuscular (IM) depot formulation indicated for the treatment of schizophrenia. Abilify Maintena is the first dopamine D2 partial agonist approved as a once- monthly injection. It contributes a new treatment option to address the ongoing need for relapse prevention in patients with schizophrenia – a chronic, debilitating disease. Efficacy was demonstrated in a 52-week, placebo-controlled, double-blind, randomized-withdrawal, Phase 3 maintenance trial of Abilify Maintena in patients with schizophrenia. The time to relapse was the primary endpoint. In the trial, Abilify Maintena (n=269 adult patients) s ... Read more

Related support groups: Abilify, Schizophrenia, Aripiprazole, Abilify Discmelt

Psychiatric Drugs More Often Prescribed in the South

Posted 1 Feb 2013 by Drugs.com

FRIDAY, Feb. 1 – Use of psychiatric medications is most prevalent in the southern United States and least prevalent in the West, according to a new U.S. study. Although people living in the West are the least likely to use antipsychotics, antidepressants and stimulants, the Yale researchers found that the drugs' use is 40 percent higher in a large section of the South than in other parts of the country. The study authors attributed this discrepancy to variations in local access to health care and marketing efforts within the pharmaceutical industry. "The geographic patterns we identify are striking and map onto the patterns found for a host of other medical conditions and treatments, from cognitive decline to bypass surgery," Marissa King, assistant professor of organizational behavior at the Yale School of Management, said in a school news release. "Our work suggests that access to ... Read more

FDA Approves Adasuve (loxapine) Inhalation Powder for the Acute Treatment of Agitation Associated with Schizophrenia or Bipolar I Disorder in Adults

Posted 21 Dec 2012 by Drugs.com

MOUNTAIN VIEW, Calif., Dec. 21, 2012 /PRNewswire/ -- Alexza Pharmaceuticals, Inc. announced today that the U.S. Food and Drug Administration (FDA) approved Adasuve (loxapine) Inhalation Powder 10 mg for the acute treatment of agitation associated with schizophrenia or bipolar I disorder in adults. Adasuve combines Alexza's proprietary Staccato® delivery system with the antipsychotic drug, loxapine. The Staccato system is a hand-held inhaler that delivers a drug aerosol to the deep lung that results in rapid systemic delivery and absorption of a drug. See below for Important Safety Information about Adasuve, including Boxed Warnings. "The approval of Adasuve is an important event in the treatment of agitation. Adasuve is the first approved non-injectable therapy for the acute treatment of agitation in adults with schizophrenia and bipolar I disorder. As noted in the consensus guidel ... Read more

Long-Term Use of Some Antipsychotics Not Warranted in Older Adults: Study

Posted 28 Nov 2012 by Drugs.com

WEDNESDAY, Nov. 28 – The safety and effectiveness of four drugs commonly used to treat older adults with schizophrenia, dementia, bipolar disorder and other mental health conditions are being called into question by a new study. The drugs – aripiprazole (Abilify), olanzapine (Zyprexa), quetiapine (Seroquel) and risperidone (Risperdal) – are among medications called atypical antipsychotics and are approved by the U.S. Food and Drug Administration to treat schizophrenia and bipolar disorders. But physicians often pen off-label prescriptions for people with dementia, post-traumatic stress disorder (PTSD) and other mood disorders to help alleviate symptoms of psychosis as well as anxiety, agitation and aggression. The medications have been in use since the early 1990s. The new study, published in the Nov. 27 issue of the Journal of Clinical Psychiatry, involved 332 patients older than 40 ... Read more

Schizophrenia Patients Who Take Antipsychotics Live Longer, Study Says

Posted 14 Nov 2012 by Drugs.com

WEDNESDAY, Nov. 14 – People with schizophrenia are likely to live longer if they take their antipsychotic drugs on schedule, avoid extremely high doses and have regular visits with a mental-health professional, according to a new study. It's long been known that adhering to a drug regimen reduces the number of the delusions and hallucinations experienced by schizophrenia patients, but there have been concerns that known physical side effects of the medications – such as diabetes and heart disease – might increase the risk of death. In this study, researchers analyzed data collected from 1994 to 2004 on more than 2,100 adult schizophrenia patients in Maryland. The most common cause of death was cardiovascular disease, which was responsible for 28 percent of patient deaths. Unintended harm, in which researchers included suicide, caused 8 percent of patient deaths during the study ... Read more

New Gene Mutations Tied to Schizophrenia

Posted 8 Oct 2012 by Drugs.com

MONDAY, Oct. 8 – Dozens of newly discovered genetic mutations that play a significant role in the development of schizophrenia add to the list of genetic variants linked to the disease, new research suggests. Schizophrenia typically appears in people during their teens or early adulthood, but many of these newly identified mutations are most active during fetal development, according to researchers from Columbia University Medical Center in New York City. They said their findings show that both the function of the mutated gene and the timing of when the gene is expressed seems to have a major effect on the risk of developing schizophrenia. The genetic errors pinpointed in this study are spontaneous, or "de novo" mutations, which means they are present in patients but not in their parents. This supports studies showing that environmental factors, such as malnutrition or infections ... Read more

Related support groups: Schizophrenia

More U.S. Kids Prescribed Off-Label Antipsychotics: Study

Posted 18 Sep 2012 by Drugs.com

TUESDAY, Sept. 18 – Over the past decade, off-label use of antipsychotic drugs has increased among children enrolled in Medicaid, according to a new study representing 35 percent of children in the United States. Off-label drug use is a term used to describe when drugs are prescribed using a dosage, type of dosage or for a purpose that hasn't yet been approved by the U.S. Food and Drug Administration. In the study, researchers from the Children's Hospital of Philadelphia found a 62 percent jump in the number of publicly insured children between the ages of 3 and 18 taking antipsychotics. In 2007 alone, 65 percent of the 354,000 children on these drugs were taking them for uses that have not been approved by the FDA, the investigators pointed out. "We knew that the number of children prescribed antipsychotics had grown steadily over the past two decades, particularly among children with ... Read more

Older Dads May Raise Risk for Autism, Schizophrenia in Kids

Posted 22 Aug 2012 by Drugs.com

WEDNESDAY, Aug. 22 – Men who have kids later in life may pass on more new genetic mutations to their offspring, possibly raising their child's risk of disorders such as autism and schizophrenia, new research suggests. New mutations arise in the sperm cells of men near the time of conception instead of being passed down through generations. They have been associated with relatively rare cases of non-hereditary autism. Researchers in Iceland searched the genomes of 78 families for new mutations as they first appeared and looked at how the number of these mutations in children was related to the age of their parents. In most of the families, the child had either non-hereditary autism or schizophrenia. The study, which was published Aug. 22 in the journal Nature, found that every year a man ages, he is predicted to pass on more than two additional new (or "de novo") mutations. More than 97 ... Read more

Related support groups: Schizophrenia, Autism

More Kids Taking Antipsychotics for ADHD: Study

Posted 7 Aug 2012 by Drugs.com

TUESDAY, Aug. 7 – Use of powerful antipsychotic medications such as Abilify and Risperdal to control youngsters with attention-deficit/hyperactivity disorder (ADHD) and other behavior problems has skyrocketed in recent years, a new study finds. Antipsychotics are approved to treat bipolar disorder, schizophrenia, other serious mental problems and irritability related to autism. But they don't have U.S. Food and Drug Administration approval for ADHD or other childhood behavior problems, and their use for this purpose is considered "off label." "Only a small proportion of antipsychotic treatment of children (6 percent) and adolescents (13 percent) is for FDA-approved clinical indications," said lead researcher Dr. Mark Olfson, a professor of clinical psychiatry at Columbia University Medical Center in New York City. "These national trends focus attention on the substantial and growing ... Read more

More Drug Trials Needed for Conditions Affecting Kids: Review

Posted 25 Jul 2012 by Drugs.com

WEDNESDAY, July 25 – A new review finds that while children account for almost 60 percent of those with five common medical conditions, only 12 percent of clinical trials of drugs for those conditions examined their effects on pediatric patients. Yet, the review authors noted, previous research has shown that off-label drugs, where the medicine has only been approved for adult use by the U.S. Food and Drug Administration, make up as much as 79 percent of the medications given to children in hospitals and up to 56 percent of drugs prescribed for kids in doctors' offices. "We think this contrast is striking, and speaks to the under-representation of research on kids," said review author Dr. Florence Bourgeois, an assistant professor of pediatrics at Boston Children's Hospital and Harvard Medical School in Boston. "Understandably, whenever we see an adverse event the concern is, 'Could ... Read more

Serious Mental Illness Tied to Higher Cancer, Injury Risk: Studies

Posted 20 Jul 2012 by Drugs.com

FRIDAY, July 20 – People with serious mental illnesses such as schizophrenia and bipolar disorder have a 2.6 times increased risk of developing cancer, a new study contends. The findings raise questions about whether people with serious mental illness receive appropriate cancer screenings and preventive care to help them avoid cancer risk factors such as smoking, the researchers said. "The increased risk is definitely there, but we're not entirely sure why," study leader Dr. Gail Daumit, an associate professor of medicine and psychiatry at the Johns Hopkins University School of Medicine, said in a Hopkins news release. "Are these people getting screened? Are they being treated? Something's going on." The researchers analyzed data from more than 3,300 Maryland Medicaid beneficiaries with schizophrenia and bipolar disorder to determine how many of them were diagnosed with cancer between ... Read more

Related support groups: Bipolar Disorder, Schizophrenia, Psychiatric Disorders

Genes Influence Whether Psych Drugs Lead to Weight Gain

Posted 20 Jul 2012 by Drugs.com

FRIDAY, July 20 – Researchers have discovered two genetic variants associated with substantial, rapid weight gain in people taking antipsychotic medications. The researchers said the findings could eventually be used by doctors to identify which patients have the variations so they can be treated without the risk of weight gain, which can lead to obesity and health problems including diabetes and heart disease. "Weight gain occurs in up to 40 percent of patients taking medications called second-generation or atypical antipsychotics, which are used because they're effective in controlling the major symptoms of schizophrenia," Dr. James Kennedy, of the Center for Addiction and Mental Health, in Toronto, said in a center news release. Kennedy, senior author of a study published online recently in the journal Archives of General Psychiatry, pinpointed a variation near the melanocortin-4 ... Read more

Schizophrenia in Movies: Don't Believe Everything You See

Posted 13 Jul 2012 by Drugs.com

FRIDAY, July 13 – Movies often stereotype people with schizophrenia as being violent and unpredictable, says a researcher who claims Hollywood dispenses misinformation about symptoms, causes and treatment of this mental illness. For the study, published in the July issue of Psychiatric Services, Patricia Owen of the psychology department at St. Mary's University in San Antonio, Texas, reviewed 41 English-language films released between 1990 and 2010 that featured at least one main character with schizophrenia. Owen found that 83 percent of those characters were portrayed as dangerous or violent to others or themselves. Almost one-third engaged in homicidal behavior, and one-quarter committed suicide, the researcher said. According to the U.S. National Institute of Mental Health, the risk of violence is small among people with schizophrenia. But suicide risk is higher than average. ... Read more

Related support groups: Schizophrenia

Family History of Schizophrenia, Bipolar Disorder May Up Kids' Risk for Autism

Posted 2 Jul 2012 by Drugs.com

MONDAY, July 2 – A new study suggests that children whose parents or siblings have schizophrenia or bipolar disorder may be at a higher risk of developing autism spectrum disorders. Researchers led by Dr. Patrick Sullivan of the University of North Carolina at Chapel Hill came to their conclusions after studying the medical records of people in Sweden and Israel. A family history of schizophrenia was strongly connected to autism disorders in children, almost tripling the risk, the team found. Children with a first-degree relative with bipolar disorder also had higher odds of developing an autism disorder, but the effect was less pronounced. It's not clear how schizophrenia and bipolar disorder might be connected to autism disorders. The research didn't prove that either of these psychiatric disorders actually causes autism, only that there is an association. Instead, all three ... Read more

Related support groups: Bipolar Disorder, Schizophrenia, Autism

Antipsychotics Do Help Many With Schizophrenia, Study Finds

Posted 3 May 2012 by Drugs.com

THURSDAY, May 3 – A new study finds that antipsychotic drugs can help many people with schizophrenia, cutting patients' risk of relapse by 60 percent. The study, involving data stretching back 50 years, also found that schizophrenia patients who take antipsychotics are much less likely to be hospitalized and may behave less aggressively and have a better quality of life than patients who don't take the drugs. One expert said the finding mirrors what he and other professionals have experienced. The data "is consistent with what we see in clinical practice – that we are very well able to keep our patients functioning better and out of the hospital when they consistently take these medications," said Dr. Roberto Estrada, attending psychiatrist at Lenox Hill Hospital in New York City. The findings are published in the May 3 online edition of The Lancet. In the study, German researchers ... Read more

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