A study published today in the Archives of Internal Medicine examines the impact of a safety warning issued by the Food and Drug Administration for commonly prescribed antipsychotic medications. The results show the warnings resulted in a decline in usage among the elderly with dementia, yet raise the question as to whether the FDA's system of communicating these warnings is sufficiently targeted and effective.
A study published today in the Archives of Internal Medicine examines the impact of a safety warning issued by the Food and Drug Administration for commonly prescribed antipsychotic medications. The results show the warnings resulted in a decline in usage among the elderly with dementia, yet raise the question as to whether the FDA’s system of communicating these warnings is sufficiently targeted and effective.
“Because this medication class has limited evidence of benefit among the elderly with dementia and significantly increases their risk of death, the ‘right’ magnitude of decline in usage is not clear,” said University of Rochester Medical Center neurologist Ray Dorsey, M.D., the study’s lead author. “More generally, the study raises larger issues about appropriate prescribing, particularly among the elderly, and the need to improve risk communication to patients and providers.”
Safety issues frequently emerge after a drug has been introduced to the market. These concerns arise either through ongoing clinical research or adverse events reported by post-market surveillance of the drug. The FDA can act upon this information in a number of ways. It can choose to remove the drug from the market or it can issue an advisory to physicians, the strongest of which is a “black box” warning which appears on the drug label.
The authors examined the impact of these warnings on a class of drugs called atypical antipsychotics. In April 2005, the FDA issued an advisory warning that elderly patients with dementia treated with these drugs were at increased risk of death.
READ MORE @ MEDIA-NEWSWIRE
Showing posts with label Atypical antipsychotics. Show all posts
Showing posts with label Atypical antipsychotics. Show all posts
Tuesday, January 12, 2010
Monday, January 4, 2010
Many antipsychotic users not getting needed tests
People who take newer drugs for Cand other psychotic conditions are supposed to have their blood sugar and cholesterol levels checked regularly but many don't, according to a study released today.
These so-called "second-generation" antipsychotic drugs, which include olanzapine (Zyprexa), risperidone (Risperdal) and aripiprazole (Abilify), were developed because older antipsychotics have significant side effects. However, the newer drugs are known to significantly increase blood sugar and cholesterol levels, raising the risk for diabetes and heart disease.
In a study, researchers found that less than one-third of low-income Medicaid patients who are treated with these drugs have their blood sugar and cholesterol levels checked.
And perhaps even more concerning, say the researchers, screening rates did not increase following government warnings and recommendations calling for increased blood sugar and cholesterol monitoring.
The findings are consistent with others from non-Medicaid populations, Dr. Elaine H. Morrato of the University of Colorado, Denver, who was involved in the study, told Reuters Health.
She has this advice: "If you are taking second-generation antipsychotic drugs, then you should be screened for diabetes and (high cholesterol and fats in the blood) and monitored for potential adverse drug effects. This is important so that you can receive appropriate preventive care and treatment."
READ MORE @ REUTERS
These so-called "second-generation" antipsychotic drugs, which include olanzapine (Zyprexa), risperidone (Risperdal) and aripiprazole (Abilify), were developed because older antipsychotics have significant side effects. However, the newer drugs are known to significantly increase blood sugar and cholesterol levels, raising the risk for diabetes and heart disease.
In a study, researchers found that less than one-third of low-income Medicaid patients who are treated with these drugs have their blood sugar and cholesterol levels checked.
And perhaps even more concerning, say the researchers, screening rates did not increase following government warnings and recommendations calling for increased blood sugar and cholesterol monitoring.
The findings are consistent with others from non-Medicaid populations, Dr. Elaine H. Morrato of the University of Colorado, Denver, who was involved in the study, told Reuters Health.
She has this advice: "If you are taking second-generation antipsychotic drugs, then you should be screened for diabetes and (high cholesterol and fats in the blood) and monitored for potential adverse drug effects. This is important so that you can receive appropriate preventive care and treatment."
READ MORE @ REUTERS
Thursday, December 31, 2009
Atypical Antipsychotics Increase Cardiometabolic Risk in Children
A study of the adverse effects of 4 second-generation antipsychotics in children and adolescents documented substantial weight gain during 11 weeks of treatment with each agent, with the increased abdominal fat that has been associated with development of metabolic syndrome in adults. Metabolic abnormalities emerged with 3 of the 4 agents, differing in type and severity with the agent and, in some cases, with the dose.
In this analysis from the Second-Generation Antipsychotic Treatment Indications, Effectiveness and Tolerability in Youth (SATIETY) study, 10% to 36% of 272 patients between 4 and 19 years of age (mean, 13.9 years) who had not previously received antipsychotic medication became overweight or obese. There was minimal weight change in a comparison group of patients who had refused the agent, or who discontinued it within 4 weeks.1
Christoph Correll, MD, Zucker Hillside Hospital, Glen Oaks, NY, and colleagues conducted this observational cohort study as the largest to date of adverse experiences with second-generation antipsychotics in antipsychotic treatment–naive children. The researchers noted that there has been increasing use of these agents in younger patients for psychotic and bipolar disorders as well as nonpsychotic disorders, despite little available age-specific data on adverse reactions.
READ MORE @ PSYCHIATRIC TIMES
In this analysis from the Second-Generation Antipsychotic Treatment Indications, Effectiveness and Tolerability in Youth (SATIETY) study, 10% to 36% of 272 patients between 4 and 19 years of age (mean, 13.9 years) who had not previously received antipsychotic medication became overweight or obese. There was minimal weight change in a comparison group of patients who had refused the agent, or who discontinued it within 4 weeks.1
Christoph Correll, MD, Zucker Hillside Hospital, Glen Oaks, NY, and colleagues conducted this observational cohort study as the largest to date of adverse experiences with second-generation antipsychotics in antipsychotic treatment–naive children. The researchers noted that there has been increasing use of these agents in younger patients for psychotic and bipolar disorders as well as nonpsychotic disorders, despite little available age-specific data on adverse reactions.
READ MORE @ PSYCHIATRIC TIMES
Wednesday, November 11, 2009
Widespread Generic Erosion of Atypical Antipsychotics Will Cause the Bipolar Disorder Drug Market to Decline By More Than $1 Billion Through 2018
Decision Resources, one of the world's
leading research and advisory firms for pharmaceutical and healthcare issues,
finds that widespread generic erosion of branded atypical antipsychotics will
cause the bipolar disorder drug market to decline from $6.3 billion in 2008 to
approximately $5 billion in 2018 in the United States, France, Germany, Italy,
Spain, the United Kingdom and Japan.
The new Pharmacor report entitled Bipolar Disorder finds that the market will
be constrained over the next several years by the patent expiries and
subsequent generic erosion of key antipsychotic agents such as AstraZeneca's
Seroquel, Eli Lilly's Zyprexa, Bristol-Myers Squibb/Otsuka's Abilify and
Pfizer's Geodon. In 2008, sales of atypical antipsychotics exceeded $4 billion
but generic competition, beginning in 2011, will cause sales of these agents
to decline to just under $3 billion by 2018, according to the report.
Additionally, patent expiries of branded antidepressants that include Wyeth's
(now Pfizer's) Effexor XR, Eli Lilly's Cymbalta/Xeristar and Forest/Lundbeck's
Lexapro/Cipralex will further constrain the market.
READ MORE @ REUTERS
leading research and advisory firms for pharmaceutical and healthcare issues,
finds that widespread generic erosion of branded atypical antipsychotics will
cause the bipolar disorder drug market to decline from $6.3 billion in 2008 to
approximately $5 billion in 2018 in the United States, France, Germany, Italy,
Spain, the United Kingdom and Japan.
The new Pharmacor report entitled Bipolar Disorder finds that the market will
be constrained over the next several years by the patent expiries and
subsequent generic erosion of key antipsychotic agents such as AstraZeneca's
Seroquel, Eli Lilly's Zyprexa, Bristol-Myers Squibb/Otsuka's Abilify and
Pfizer's Geodon. In 2008, sales of atypical antipsychotics exceeded $4 billion
but generic competition, beginning in 2011, will cause sales of these agents
to decline to just under $3 billion by 2018, according to the report.
Additionally, patent expiries of branded antidepressants that include Wyeth's
(now Pfizer's) Effexor XR, Eli Lilly's Cymbalta/Xeristar and Forest/Lundbeck's
Lexapro/Cipralex will further constrain the market.
READ MORE @ REUTERS
Thursday, October 22, 2009
Texas Lawsuit Blames Antipsychotic Seroquel for Woman’s Diabetes
Taking Seroquel to treat a mental disorder caused a Texas woman to develop diabetes and she wouldn’t have taken the drug if she knew of the risks, according to a lawsuit filed in Texas federal court.
Misty Peters claims she took the atypical antipsychotic drug, which is approved for treating schizophrenia and bipolar disorder but also is widely used by physicians to treat other unapproved “off-label” conditions, according to a report in the Southeast Texas Record.
Peters’ product liability lawsuit, filed last week in the Beaumont Division of the Eastern District of Texas, accuses Seroquel’s maker, Astra Zeneca Pharmaceuticals, and others of promoting the drug’s benefits and downplaying its risks while knowing it could cause users to develop diabetes and other medical problems.
Seroquel Linked to Diabetes, Other Blood-Sugar Disorders
Seroquel was approved by the Food and Drug Administration in 1997 as a member of a newer class of drugs called atypical antipsychotics. The drugs, which control levels of dopamine in the brain, are billed as being just as effective as older antipsychotic drugs like Haldol with fewer side effects, but more recent research has found a link between taking Seroquel and developing diabetes and other blood-sugar disorders.
READ MORE @ ATORNEY AT LAW
Misty Peters claims she took the atypical antipsychotic drug, which is approved for treating schizophrenia and bipolar disorder but also is widely used by physicians to treat other unapproved “off-label” conditions, according to a report in the Southeast Texas Record.
Peters’ product liability lawsuit, filed last week in the Beaumont Division of the Eastern District of Texas, accuses Seroquel’s maker, Astra Zeneca Pharmaceuticals, and others of promoting the drug’s benefits and downplaying its risks while knowing it could cause users to develop diabetes and other medical problems.
Seroquel Linked to Diabetes, Other Blood-Sugar Disorders
Seroquel was approved by the Food and Drug Administration in 1997 as a member of a newer class of drugs called atypical antipsychotics. The drugs, which control levels of dopamine in the brain, are billed as being just as effective as older antipsychotic drugs like Haldol with fewer side effects, but more recent research has found a link between taking Seroquel and developing diabetes and other blood-sugar disorders.
READ MORE @ ATORNEY AT LAW
Saturday, September 19, 2009
Ziprasidone Plus Lithium or Divalproex Is More Effective Than Monotherapy in Bipolar Disorder: Presented at ECNP
Ziprasidone as adjunctive treatment of bipolar disorder yields better efficacy than monotherapy and does not have the side effect of weight gain, according to researchers here at the 22nd European College of Neuropsychopharmacology (ECNP) Congress.
Eduard Vieta, MD, Bipolar Disorders Program, Clinical Institute of Neuroscience, Barcelona, Spain, and colleagues investigated the efficacy of combining ziprasidone with standard mood stabilisers. Because few bipolar patients experience adequate symptom control with long-term lithium or divalproex therapy, the use of adjunctive treatment with atypical antipsychotics is being investigated.
READ MORE @ DOCTOR'S GUIDE
Eduard Vieta, MD, Bipolar Disorders Program, Clinical Institute of Neuroscience, Barcelona, Spain, and colleagues investigated the efficacy of combining ziprasidone with standard mood stabilisers. Because few bipolar patients experience adequate symptom control with long-term lithium or divalproex therapy, the use of adjunctive treatment with atypical antipsychotics is being investigated.
READ MORE @ DOCTOR'S GUIDE
Wednesday, July 15, 2009
Schizophrenia Drug Limits May Have Led to Deaths (Update1)
Restrictions on the use of the antipsychotic medicine clozapine may have led to thousands of additional deaths in schizophrenia patients around the world, a study published in The Lancet medical journal found.
Researchers examined data from patients taking the six most frequently used antipsychotic drugs and found that clozapine was associated with the lowest death rate compared with use of the older medicine perphenazine. Clozapine was linked to a 26 percent reduction in mortality according to the study, led by Jari Tiihonen at the University of Kuopio in Finland.
Doctors can prescribe clozapine, first developed by Switzerland’s Novartis AG, only after two unsuccessful trials with other antipsychotics because it has been linked with agranulocytosis, a condition causing a severe decrease in white blood cells and problems such as fevers, fatigue and bleeding sores, Tiihonen said. Patients taking clozapine need weekly blood monitoring for six months followed by monthly testing to look for signs of the disorder, he said.
“Our results raise the issue of whether clozapine should be used as a first-line treatment, because it seems to be the safest antipsychotic in terms of mortality and it is also the most effective,” Tiihonen and colleagues wrote in the study. “However, clozapine is inexpensive, and hence it’s unprofitable for the pharmaceutical industry to market compared with other second-generation antipsychotic drugs.”
READ MORE @ BLOOMBERG
Researchers examined data from patients taking the six most frequently used antipsychotic drugs and found that clozapine was associated with the lowest death rate compared with use of the older medicine perphenazine. Clozapine was linked to a 26 percent reduction in mortality according to the study, led by Jari Tiihonen at the University of Kuopio in Finland.
Doctors can prescribe clozapine, first developed by Switzerland’s Novartis AG, only after two unsuccessful trials with other antipsychotics because it has been linked with agranulocytosis, a condition causing a severe decrease in white blood cells and problems such as fevers, fatigue and bleeding sores, Tiihonen said. Patients taking clozapine need weekly blood monitoring for six months followed by monthly testing to look for signs of the disorder, he said.
“Our results raise the issue of whether clozapine should be used as a first-line treatment, because it seems to be the safest antipsychotic in terms of mortality and it is also the most effective,” Tiihonen and colleagues wrote in the study. “However, clozapine is inexpensive, and hence it’s unprofitable for the pharmaceutical industry to market compared with other second-generation antipsychotic drugs.”
READ MORE @ BLOOMBERG
Sunday, June 14, 2009
FDA Throws Lifeline to Antipsychotic Pushers
On June 11, 2009, FDA News reported that AstraZeneca’s Seroquel, Pfizer’s Geodon and Eli Lilly’s Zyprexa atypical antipsychotics "won an FDA advisory panel’s recommendations for approval to treat schizophrenia and bipolar disorder in pediatric and adolescent patients."
"The FDA's expanded marketing approval process for antipsychotics, highly toxic drugs, is unaffected by evidence uncovered by the US Justice Department showing that the studies submitted by drug manufacturers were often flawed, if not fraudulent," says Vera Hassner Sharav, president of the Alliance for Human Research Protection, in a June 8, 2009 infomail alert.
"Rather than focus on protecting children's safety, FDA officials are doing their utmost to legitimize irresponsible, off-label prescribing of exceedingly toxic antipsychotics for children--thereby ensuring that far greater numbers of children will be victimized and die," according to Sharav.
A recent report by the consulting firm Decision Resources found antipsychotics makers spent $993,000,000 in 2006, to promote these drugs to doctors and patients, she reports. In 2008, at more than $14 billion, antipsychotic revenues topped all other classes of drugs in the US, even cholesterol and diabetes medications.
READ MORE @ COUNTERPUNCH
"The FDA's expanded marketing approval process for antipsychotics, highly toxic drugs, is unaffected by evidence uncovered by the US Justice Department showing that the studies submitted by drug manufacturers were often flawed, if not fraudulent," says Vera Hassner Sharav, president of the Alliance for Human Research Protection, in a June 8, 2009 infomail alert.
"Rather than focus on protecting children's safety, FDA officials are doing their utmost to legitimize irresponsible, off-label prescribing of exceedingly toxic antipsychotics for children--thereby ensuring that far greater numbers of children will be victimized and die," according to Sharav.
A recent report by the consulting firm Decision Resources found antipsychotics makers spent $993,000,000 in 2006, to promote these drugs to doctors and patients, she reports. In 2008, at more than $14 billion, antipsychotic revenues topped all other classes of drugs in the US, even cholesterol and diabetes medications.
READ MORE @ COUNTERPUNCH
Thursday, June 11, 2009
Cardiac Risk Same With Typical and Atypical Antipsychotics
Second-generation (atypical) antipsychotic drugs may not have an advantage for cardiovascular risk over typical antipsychotics, according to a recent, large retrospective cohort study. Researchers at the Vanderbilt University School of Medicine in Tennessee found that risk of sudden cardiac death is heightened with antipsychotics, whether typical or atypical, and the risk increases significantly with increasing doses.
In a recent issue of the New England Journal of Medicine, lead investigator Wayne Ray, PhD, and colleagues,1 report that while a favorable extrapyramidal adverse–effect profile has led many to consider atypical antipsychotics safer than typical antipsychotics for cardiac risk, “the atypical antipsychotic drugs are no safer than the older drugs.”
The study was designed to detect an increased incidence of sudden cardiac death in patients treated with antipsychotics. The researchers identified new users of the study drugs and established the temporal relationship between patient characteristics before treatment and outcomes after treatment initiation. They analyzed data from 44,218 patients treated with a typical antipsychotic, 46,089 patients treated with an atypical antipsychotic, and 186,600 matched nonusers. The participants’ mean age was 45.7 years. The analysis controlled for an array of cardiovascular disease variables.
READ MORE @ PSYCHIATRIC TIMES
In a recent issue of the New England Journal of Medicine, lead investigator Wayne Ray, PhD, and colleagues,1 report that while a favorable extrapyramidal adverse–effect profile has led many to consider atypical antipsychotics safer than typical antipsychotics for cardiac risk, “the atypical antipsychotic drugs are no safer than the older drugs.”
The study was designed to detect an increased incidence of sudden cardiac death in patients treated with antipsychotics. The researchers identified new users of the study drugs and established the temporal relationship between patient characteristics before treatment and outcomes after treatment initiation. They analyzed data from 44,218 patients treated with a typical antipsychotic, 46,089 patients treated with an atypical antipsychotic, and 186,600 matched nonusers. The participants’ mean age was 45.7 years. The analysis controlled for an array of cardiovascular disease variables.
READ MORE @ PSYCHIATRIC TIMES
Sunday, June 7, 2009
FDA Reverses Earlier Decision, Approves Schizophrenia Drug
The new antipsychotic medication has pharmacological and clinical profiles similar to those of other second-generation drugs on the market and appears to carry comparable risks.
After being turned down by the Food and Drug Administration (FDA) almost a year ago, iloperidone has gained approval for the acute treatment of schizophrenia in adult patients.
Iloperidone is a second-generation antipsychotic (SGA) medication mixed antagonism for dopamine D2 and serotonin 5HT2A receptors and is owned by Vanda Pharmaceuticals.
In two randomized, placebo-controlled, phase-3 trials in patients with schizophrenia, iloperidone was found more efficacious than placebo in reducing schizophrenia symptoms among study subjects.
In one trial, 604 patients with schizophrenia received iloperidone 24 mg/day, placebo, or ziprasidone for four weeks, with patients on iloperidone showing significant benefits in Positive and Negative Syndrome Scale total scores compared with placebo. In the other trial, involving 706 patients, iloperidone was compared with placebo and risperidone. After six weeks, the drug was superior to placebo in the reduction of total score on the Brief Psychiatric Rating Scale. The company did not release any data on how iloperidone compared with either ziprasidone or risperidone on efficacy indicators.
READ MORE @ PSYCHIATRIC NEWS
After being turned down by the Food and Drug Administration (FDA) almost a year ago, iloperidone has gained approval for the acute treatment of schizophrenia in adult patients.
Iloperidone is a second-generation antipsychotic (SGA) medication mixed antagonism for dopamine D2 and serotonin 5HT2A receptors and is owned by Vanda Pharmaceuticals.
In two randomized, placebo-controlled, phase-3 trials in patients with schizophrenia, iloperidone was found more efficacious than placebo in reducing schizophrenia symptoms among study subjects.
In one trial, 604 patients with schizophrenia received iloperidone 24 mg/day, placebo, or ziprasidone for four weeks, with patients on iloperidone showing significant benefits in Positive and Negative Syndrome Scale total scores compared with placebo. In the other trial, involving 706 patients, iloperidone was compared with placebo and risperidone. After six weeks, the drug was superior to placebo in the reduction of total score on the Brief Psychiatric Rating Scale. The company did not release any data on how iloperidone compared with either ziprasidone or risperidone on efficacy indicators.
READ MORE @ PSYCHIATRIC NEWS
Friday, June 5, 2009
Antipsychotic drugs appear to work in kids: FDA staff
Three antipsychotic drugs appear to work in children and teens but their risks must be weighed as the makers seek to promote them for younger patients, the head of the U.S. Food and Drug Administration's psychiatric division said in a memo released on Friday.
The FDA has yet to make a final decision on whether to approve drugs made by AstraZeneca, Pfizer and Eli Lilly and Co for children and teens with schizophrenia or bipolar disorder.
An FDA panel is to meet next week to give recommendations on the companies' bid to promote the drugs for children and teenagers with schizophrenia or bipolar disorder.
Doctors can already prescribe the medications for children, but FDA approval would allow the manufacturers to market them more widely.
The drugs, known as atypical antipsychotics, are widely used to treat various psychiatric conditions but have come under scrutiny for links to weight gain.
"We generally are in agreement that the sponsors have provided adequate support to suggest effectiveness," FDA's Thomas Laughren wrote in the memo released on Friday.
He added that the safety of the drugs in children appeared "to be qualitatively similar to those observed with these drugs in adult patients."
READ MORE @ REUTERS
The FDA has yet to make a final decision on whether to approve drugs made by AstraZeneca, Pfizer and Eli Lilly and Co for children and teens with schizophrenia or bipolar disorder.
An FDA panel is to meet next week to give recommendations on the companies' bid to promote the drugs for children and teenagers with schizophrenia or bipolar disorder.
Doctors can already prescribe the medications for children, but FDA approval would allow the manufacturers to market them more widely.
The drugs, known as atypical antipsychotics, are widely used to treat various psychiatric conditions but have come under scrutiny for links to weight gain.
"We generally are in agreement that the sponsors have provided adequate support to suggest effectiveness," FDA's Thomas Laughren wrote in the memo released on Friday.
He added that the safety of the drugs in children appeared "to be qualitatively similar to those observed with these drugs in adult patients."
READ MORE @ REUTERS
Monday, May 4, 2009
AAN: Atypical Antipsychotic Reduces Autism Irritability
Aripiprazole (Abilify) may be effective off-label for treating the irritability associated with autism, researchers here said.
The atypical antipsychotic fared significantly better than placebo on a parent-rated scale of irritability (P<0.05), Donald Lewis, M.D., of Sentara Norfolk General Hospital in Virginia, and colleagues reported at the American Academy of Neurology meeting.
It also had significant advantages over placebo with regard to clinician assessments of Aripiprazole and hyperactivity.
Only one atypical antipsychotic -- risperidone (Risperdal) -- is currently FDA approved for irritability associated with autism. However, treatment guidelines recommended that other atypical antipsychotics be considered for behavioral problems in autism.
Researchers involved in the current study could not comment on whether aripiprazole was in the process of FDA approval for this indication.
But Benjamin L. Handen, Ph.D., of the University of Pittsburgh, who was not involved in this study but is involved in similar trials, said FDA approval for the indication would give doctors an alternative for children who respond poorly to risperidone.
READ MORE @ MEDPAGE TODAY
The atypical antipsychotic fared significantly better than placebo on a parent-rated scale of irritability (P<0.05), Donald Lewis, M.D., of Sentara Norfolk General Hospital in Virginia, and colleagues reported at the American Academy of Neurology meeting.
It also had significant advantages over placebo with regard to clinician assessments of Aripiprazole and hyperactivity.
Only one atypical antipsychotic -- risperidone (Risperdal) -- is currently FDA approved for irritability associated with autism. However, treatment guidelines recommended that other atypical antipsychotics be considered for behavioral problems in autism.
Researchers involved in the current study could not comment on whether aripiprazole was in the process of FDA approval for this indication.
But Benjamin L. Handen, Ph.D., of the University of Pittsburgh, who was not involved in this study but is involved in similar trials, said FDA approval for the indication would give doctors an alternative for children who respond poorly to risperidone.
READ MORE @ MEDPAGE TODAY
Sunday, April 19, 2009
Alzheimer’s Patients on Atypical Antipsychotics Experience “Significant” Weight Gain
Some newer, atypical, or second-generation, antipsychotic medications have been found to have two serious adverse reactions. The drugs both lower so-called “good” cholesterol and cause weight gain in older Alzheimer patients.
HealthDay News reports that in a study of over 400 elderly patients, medications such as Zyprexa (olanzapine) and Seroquel (quetiapine) were both linked to “significant” weight gain, saying that those patients specifically taking Zyprexa “experienced increases in waist circumference and declines in HDL cholesterol,” as well. The study also revealed that the weight gain correlated to the amount of time the patient was on the medication; the longer the patient was taking the drug, the more weight gained, said HealthDay News.
The findings from the Clinical Antipsychotic Trials of Intervention Effectiveness—Alzheimer’s Disease (CATIE-AD) study, were funded by the U.S. National Institute of Mental Health (NIMH), said HealthDay News, and appear in the April 15 issue of the American Journal of Psychiatry. “These findings are especially troubling, because antipsychotics are associated with a higher risk of death and cerebrovascular adverse events in patients with dementia. They’re often used to minimize disruptive symptoms (such as psychosis or agitation), but patients should be monitored more closely,” said lead investigator Dr. Lon S. Schneider, in an American Psychiatric Association news release, quoted HealthDay News. The team noted that similar “metabolic side effects” have been seen in schizophrenia patients taking the newer antipsychotics, said HealthDay News.
READ MORE @ NEWS INFERNO
HealthDay News reports that in a study of over 400 elderly patients, medications such as Zyprexa (olanzapine) and Seroquel (quetiapine) were both linked to “significant” weight gain, saying that those patients specifically taking Zyprexa “experienced increases in waist circumference and declines in HDL cholesterol,” as well. The study also revealed that the weight gain correlated to the amount of time the patient was on the medication; the longer the patient was taking the drug, the more weight gained, said HealthDay News.
The findings from the Clinical Antipsychotic Trials of Intervention Effectiveness—Alzheimer’s Disease (CATIE-AD) study, were funded by the U.S. National Institute of Mental Health (NIMH), said HealthDay News, and appear in the April 15 issue of the American Journal of Psychiatry. “These findings are especially troubling, because antipsychotics are associated with a higher risk of death and cerebrovascular adverse events in patients with dementia. They’re often used to minimize disruptive symptoms (such as psychosis or agitation), but patients should be monitored more closely,” said lead investigator Dr. Lon S. Schneider, in an American Psychiatric Association news release, quoted HealthDay News. The team noted that similar “metabolic side effects” have been seen in schizophrenia patients taking the newer antipsychotics, said HealthDay News.
READ MORE @ NEWS INFERNO
Wednesday, February 11, 2009
Use of Atypical Antipsychotic Drugs Increases Risk of Sudden Cardiac Death
Patients aged 30 to 74 years who took atypical antipsychotics such as risperidone (Risperdal), quetiapine (Seroquel), olanzapine (Zyprexa), and clozapine (Clozaril) had a significantly higher risk of sudden death from cardiac arrhythmias and other cardiac causes than patients who did not take these medications, according to a study published in the January 15 issue of the New England Journal of Medicine.
"This study provides critical information about the safety of atypical antipsychotics that can be used to make important treatment decisions for patients," said Carolyn M. Clancy, MD, Agency for Healthcare Research & Quality, Rockville, Maryland.
"These findings will help clinicians and patients weigh the risks versus the benefits of these drugs before prescribing them for treatment of depression or other off-label uses for other conditions."
READ MORE @ DOCTOR'S GUIDE
"This study provides critical information about the safety of atypical antipsychotics that can be used to make important treatment decisions for patients," said Carolyn M. Clancy, MD, Agency for Healthcare Research & Quality, Rockville, Maryland.
"These findings will help clinicians and patients weigh the risks versus the benefits of these drugs before prescribing them for treatment of depression or other off-label uses for other conditions."
READ MORE @ DOCTOR'S GUIDE
Sunday, February 1, 2009
Bitter Pill
Created to treat schizophrenia, Zyprexa wound up being used on misbehaving kids. How the pharmaceutical industry turned a flawed and dangerous drug into a $16 billion bonanza
In June 1992, not long after the place closed down, a Harvard-trained psychologist named Sergio Pirrotta walked out of Danvers State Hospital for the last time. The psychiatric facility, at this late date, was a baggy old thing, rectangled into a field just north of Boston; whole wings were barely occupied, and vandals had already begun to rip out the mantelpieces and furniture. The hospital had been slowly, incrementally shutting down for a decade, and the patients that remained were the hardest cases, mostly schizophrenics and those with disorders too dense and weird to classify. But now, as Pirrotta took a walk around the campus, even those patients were gone: released into the larger world to fend for themselves or bused to hospitals where the staffs had little psychiatric training.
Pirrotta had come to Danvers in the mid-1970s to rehabilitate children whom the courts had declared insane. Back then the place was overpopulated, the halls packed with madmen who would wander around smoking cigarettes, leering and lunging at the kids. In those days, the drugs used to treat mental illness were crude and ugly things. Thorazine was the best, and it made you into a ghouled and lifeless ogre — your face seized up involuntarily, you kept shuffling around, you were an emotional drone. But gradually the medications got a little bit better, the pharmacology more precise. First there was haloperidol, similar to Thorazine but with less-vivid side effects. Then clozapine, which had at first seemed a wonder drug, before it turned out to trigger a potentially fatal immune deficiency in two cases out of a hundred.
READ MORE @ ROLLING STONE
In June 1992, not long after the place closed down, a Harvard-trained psychologist named Sergio Pirrotta walked out of Danvers State Hospital for the last time. The psychiatric facility, at this late date, was a baggy old thing, rectangled into a field just north of Boston; whole wings were barely occupied, and vandals had already begun to rip out the mantelpieces and furniture. The hospital had been slowly, incrementally shutting down for a decade, and the patients that remained were the hardest cases, mostly schizophrenics and those with disorders too dense and weird to classify. But now, as Pirrotta took a walk around the campus, even those patients were gone: released into the larger world to fend for themselves or bused to hospitals where the staffs had little psychiatric training.
Pirrotta had come to Danvers in the mid-1970s to rehabilitate children whom the courts had declared insane. Back then the place was overpopulated, the halls packed with madmen who would wander around smoking cigarettes, leering and lunging at the kids. In those days, the drugs used to treat mental illness were crude and ugly things. Thorazine was the best, and it made you into a ghouled and lifeless ogre — your face seized up involuntarily, you kept shuffling around, you were an emotional drone. But gradually the medications got a little bit better, the pharmacology more precise. First there was haloperidol, similar to Thorazine but with less-vivid side effects. Then clozapine, which had at first seemed a wonder drug, before it turned out to trigger a potentially fatal immune deficiency in two cases out of a hundred.
READ MORE @ ROLLING STONE
Friday, January 16, 2009
Study Finds Drug Risks With Newer Antipsychotics
The popular drugs known as atypical antipsychotics, prescribed for an array of conditions, including schizophrenia, autism and dementia, double patients’ risk of dying from sudden heart failure, a study has found.
The finding is the latest in a succession of recent reports contradicting the long-held assumption that the new drugs, which include Risperdal, Zyprexa and Seroquel, are safer than the older and much less expensive medications that they replaced.
The risk of death from the drugs is not high, on average about 3 percent in a person being treated at least 10 years, according to the study, published Thursday in The New England Journal of Medicine. Nor was the risk different from that of the older antipsychotic drugs.
But it was significant enough that an accompanying editorial urged doctors to limit their prescribing of antipsychotic drugs, especially to children and elderly patients,who can be highly susceptible to the drugs’ side effects, including rapid weight gain.
READ MORE @ NY TIMES
The finding is the latest in a succession of recent reports contradicting the long-held assumption that the new drugs, which include Risperdal, Zyprexa and Seroquel, are safer than the older and much less expensive medications that they replaced.
The risk of death from the drugs is not high, on average about 3 percent in a person being treated at least 10 years, according to the study, published Thursday in The New England Journal of Medicine. Nor was the risk different from that of the older antipsychotic drugs.
But it was significant enough that an accompanying editorial urged doctors to limit their prescribing of antipsychotic drugs, especially to children and elderly patients,who can be highly susceptible to the drugs’ side effects, including rapid weight gain.
READ MORE @ NY TIMES
Saturday, December 13, 2008
Not All Antipsychotics Created Equal: Analysis Reveals Important Differences
An analysis of studies on antipsychotics reveals multiple differences among the newer, second-generation antipsychotics as well as the older medications, and suggests the current classification system blurs important differences, rendering it unhelpful. The analysis, partially funded by NIMH, was published online December 5, 2008, in The Lancet.
An analysis of studies on antipsychotics reveals multiple differences among the newer, second-generation antipsychotics as well as the older medications, and suggests the current classification system blurs important differences, rendering it unhelpful. The analysis, partially funded by NIMH, was published online December 5, 2008, in The Lancet.
Stefan Leucht, M.D., of Technische Universität München in Munich, Germany, and colleagues looked at 150 studies from all parts of the world with a total of 21,533 participants. By examining these double-blind studies, they were able to compare nine second-generation—also called atypical—antipsychotics with first-generation antipsychotics. They examined symptom reduction; quality of life; side effects such as movement disorders, weight gain and sedation ( sleepiness ); and other factors.
READ MORE @ MEDIA NEWSWIRE
An analysis of studies on antipsychotics reveals multiple differences among the newer, second-generation antipsychotics as well as the older medications, and suggests the current classification system blurs important differences, rendering it unhelpful. The analysis, partially funded by NIMH, was published online December 5, 2008, in The Lancet.
Stefan Leucht, M.D., of Technische Universität München in Munich, Germany, and colleagues looked at 150 studies from all parts of the world with a total of 21,533 participants. By examining these double-blind studies, they were able to compare nine second-generation—also called atypical—antipsychotics with first-generation antipsychotics. They examined symptom reduction; quality of life; side effects such as movement disorders, weight gain and sedation ( sleepiness ); and other factors.
READ MORE @ MEDIA NEWSWIRE
Sunday, December 7, 2008
No Reason to Prefer Atypical Antipsychotics over Older Drugs
The common distinction between first- and second-generation antipsychotic drugs has no scientific basis and should be dropped, said researchers here.
A meta-analysis of 150 double-blind studies found little evidence that newer, so-called atypical antipsychotic drugs are more effective than older drugs for symptoms of schizophrenia, reported Stefan Leucht, M.D., of Munich Technical University, and colleagues online in The Lancet.
The researchers also found that although newer drugs induced fewer extrapyramidal effects than haloperidol (Haldol) that was not the case when compared with low-potency first-generation agents.
"Second-generation antipsychotic drugs differ in many properties" -- including structure and mode of action as well as clinical effects -- "and are not a homogeneous class," the researchers concluded.
"Improper generalization creates confusion and, as a result, the classification [of first- versus second-generation agents] might be abandoned," they said.
READ MORE @ MEDPAGE TODAY
A meta-analysis of 150 double-blind studies found little evidence that newer, so-called atypical antipsychotic drugs are more effective than older drugs for symptoms of schizophrenia, reported Stefan Leucht, M.D., of Munich Technical University, and colleagues online in The Lancet.
The researchers also found that although newer drugs induced fewer extrapyramidal effects than haloperidol (Haldol) that was not the case when compared with low-potency first-generation agents.
"Second-generation antipsychotic drugs differ in many properties" -- including structure and mode of action as well as clinical effects -- "and are not a homogeneous class," the researchers concluded.
"Improper generalization creates confusion and, as a result, the classification [of first- versus second-generation agents] might be abandoned," they said.
READ MORE @ MEDPAGE TODAY
Monday, November 24, 2008
Psychiatrists Give Mixed Reviews on ACP Antidepressant Guideline
A practice guideline on the use of second-generation antidepressants, issued here this week by the American College of Physicians, has earned cheers as well as jeers from psychiatrists.
"I don't see anything that's at variance with the American Psychiatric Association's [current] treatment guidelines or the ones that are in process now," said Alan Gelenberg, M.D., chair of the APA's working group on depression management and clinical professor of psychiatry at the University of Wisconsin.
The group is now revising the APA's guidelines on the topic.
"I just applaud them for taking depression seriously," Dr. Gelenberg added.
But a past chair of the group, T. Byram Karasu, M.D., of Albert Einstein College of Medicine in New York, who was lead author of the APA's existing depression guideline, slammed the ACP effort, calling it the "worst possible practice."
The ACP's guideline was based on a review of 203 clinical trials involving selective serotonin reuptake inhibitors (SSRIs), selective norepinephrine reuptake inhibitors, and other antidepressants introduced in the last 20 years.
READ MORE @ MEDPAGE TODAY
"I don't see anything that's at variance with the American Psychiatric Association's [current] treatment guidelines or the ones that are in process now," said Alan Gelenberg, M.D., chair of the APA's working group on depression management and clinical professor of psychiatry at the University of Wisconsin.
The group is now revising the APA's guidelines on the topic.
"I just applaud them for taking depression seriously," Dr. Gelenberg added.
But a past chair of the group, T. Byram Karasu, M.D., of Albert Einstein College of Medicine in New York, who was lead author of the APA's existing depression guideline, slammed the ACP effort, calling it the "worst possible practice."
The ACP's guideline was based on a review of 203 clinical trials involving selective serotonin reuptake inhibitors (SSRIs), selective norepinephrine reuptake inhibitors, and other antidepressants introduced in the last 20 years.
READ MORE @ MEDPAGE TODAY
Tuesday, November 18, 2008
Use of Antipsychotics in Children Is Criticized
Powerful antipsychotic medicines are being used far too cavalierly in children, and federal drug regulators must do more to warn doctors of their substantial risks, a panel of federal drug experts said Tuesday.
More than 389,000 children and teenagers were treated last year with Risperdal, one of five popular medicines known as atypical antipsychotics. Of those patients, 240,000 were 12 or younger, according to data presented to the committee. In many cases, the drug was prescribed to treat attention deficit disorders.
But Risperdal is not approved for attention deficit problems, and its risks — which include substantial weight gain, metabolic disorders and muscular tics that can be permanent — are too profound to justify its use in treating such disorders, panel members said.
READ MORE @ NY TIMES
More than 389,000 children and teenagers were treated last year with Risperdal, one of five popular medicines known as atypical antipsychotics. Of those patients, 240,000 were 12 or younger, according to data presented to the committee. In many cases, the drug was prescribed to treat attention deficit disorders.
But Risperdal is not approved for attention deficit problems, and its risks — which include substantial weight gain, metabolic disorders and muscular tics that can be permanent — are too profound to justify its use in treating such disorders, panel members said.
READ MORE @ NY TIMES
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