A new federally funded study by HHS Agency for Healthcare Research and
Quality, found little or no evidence to support the widespread off-label
use of these drugs: "Most off-label use occurs without scientific support."
Furthermore, the study, Efficacy and Comparative Effectiveness of
Off-Label Use of Atypical Antipsychotics, confirmed that these drugs
increase the risk of serious adverse events–including an increased risk of
death and increased chances of stroke, neurological problems.
Overall the researchers found that "much of the scientific evidence for
off-label use of antipsychotics was of insufficient quality because studies
were too small or lacked scientific rigor. Review authors evaluating the
potential benefits and risks of the medications also found strong evidence
that atypical antipsychotics can increase chances of adverse events."
State and federal mental health prescription guidelines need to be
disinfected: mental health providers have been seduced by Big Pharma and its
made to order prescribing guidelines–TMAP (Texas Medication Algorithm
Project) and its clones must be declared invalid as they pose a public
If doctors can't say NO to drug sales reps, Congress has to stop this
collusion that is undermining the health of Americans.
Doctors guided by sales reps have derailed medicine from its therapeutic
mission. Doctors are prescribing toxic drugs for millions of
Americans–undermining their physical and mental health in the process.
Doctors in the service of drug companies are sacrificing lives to increase
Contact: Vera Hassner Sharav
Source: Agency for Healthcare Research and Quality (AHRQ)
<http://www.newswise.com/institutions/view/?id=288> Released: Thu
18-Jan-2007, 20:05 ET
No Evidence to Support Many Off-label Uses of Atypical Antipsychotics
DEPRESSION DRUGS "MENTAL HEALTH" PSYCHOTIC EVIDENCE
Some newer antipsychotic medications approved to treat schizophrenia and
bipolar disorder are being prescribed "off-label" to millions of Americans
for depression, dementia, and other psychiatric disorders without strong
evidence that these uses are effective.
Newswise – Some newer antipsychotic medications approved to treat
schizophrenia and bipolar disorder are being prescribed to millions of
Americans for depression, dementia, and other psychiatric disorders without
strong evidence that such off-label uses are effective, according to a new
analysis by HHS' Agency for Healthcare Research and Quality.
The federally funded comparative effectiveness review of these drugs –
called atypical antipsychotics – identified the medications' potential for
serious side effects while pointing to an "urgent need" for more research
into new treatments for the growing population of dementia patients who
display severe agitation.
"This report emphasizes the importance of understanding the risks and
benefits of different medicines," said AHRQ Director Carolyn M. Clancy, M.D.
"Caution is necessary in the off-label use of atypical antipsychotics,
especially when used in the elderly and when the evidence for effectiveness
is not good.''
Atypical antipsychotics are second-generation medicines designed to cause
fewer neurological complications than conventional antipsychotics. They
include aripiprazole (sold as Abilify), olanzapine (Zyprexa), quetiapine
(Seroquel), risperidone (Risperdal), and ziprasidone (Geodon). Each is
approved by the Food and Drug Administration to treat schizophrenia and
bipolar disorder, and risperidone is also approved to treat irritability in
children ages 5 to 16 who have autism.
Some studies suggest that atypical antipsychotics may help patients with
mental health conditions for which there are no FDA-approved alternatives.
Risperidone and quetiapine, for example, help certain patients with
obsessive-compulsive disorder when used in conjunction with antidepressants.
Risperidone and olanzapine improve sleep problems, depression, and other
symptoms in men with combat-related post-traumatic stress disorder when used
to augment therapy with antidepressants or other psychotropic medications.
Overall, however, researchers found that much of the scientific evidence for
off-label use of antipsychotics was of insufficient quality because studies
were too small or lacked scientific rigor.
Review authors evaluating the potential benefits and risks of the
medications also found strong evidence that atypical antipsychotics can
increase chances of adverse events. Some of the drugs increase risks of
stroke, tremors, significant weight gain, sedation, and gastrointestinal
The new review was produced by AHRQ's Effective Health Care program. It was
authored by AHRQ's Southern California/RAND Evidence-based Practice Center.
The center examined 84 published studies on atypical antipsychotics and
summarized evidence about several conditions:
Dementia: One analysis showed a small benefit for risperidone and
aripiprazole in the treatment of agitation and psychosis. Another suggested
olanzapine may help treat psychosis. But a large clinical trial that
explored whether risperidone, olanzapine, and quetiapine controlled
behavioral disturbances in Alzheimer's patients concluded that the risks of
adverse events offset the potential benefits.
Overall, analyses identified potential harms as a small increase in the risk
of death and increased chances of stroke, neurological problems (such as
tremors or muscle contractions), and weight gain.
Depression: For patients who don't benefit from selective serotonin reuptake
inhibitors (SSRIs), the supplemental use of atypical antipsychotics was not
helpful, according to research.
No studies showed the drugs provided a clear benefit for patients with major
depressive disorder with psychotic features. Evidence is conflicting for
Obsessive-Compulsive Disorder: Atypical antipsychotics significantly helped
patients who don't respond adequately to SSRI therapy, studies showed.
Overall, patients taking the drugs were about 2.7 times as likely to improve
as patients taking placebo. The chances of benefiting were best for
risperidone and quetiapine.
Post-Traumatic Stress Disorder: Studies of men with combat-related PTSD
showed risperidone and olanzapine, when used with antidepressants or other
psychotropic medications, improved sleep quality, anxiety, and other
symptoms. Studies were inconclusive when measuring benefits for women.
Personality Disorders: For patients with borderline personality disorder,
one study suggested olanzapine was more effective than placebo but showed
little benefit when used to augment talk therapy. All studies of olanzapine
were very small, however, and patients experienced significant weight gain.
Two other small trials suggested risperidone may benefit patients with
schizotypal personality disorder, and aripiprazole may help patients with
borderline personality disorder.
Tourette's Syndrome: Risperidone is more effective than placebo, according
to a small body of research. The benefits of ziprasidone are uncertain.
Off-label prescribing is a common but relatively understudied practice in
health care. A 2001 AHRQ-funded study concluded that about 21 percent of
prescribed drug use was for conditions not indicated on the label. Cardiac
medications and anticonvulsants were the drugs most commonly used off label.
Most off-label use occurs without scientific support, the study said.
The report released today, Efficacy and Comparative Effectiveness of
Off-Label Use of Atypical Antipsychotics, is the newest analysis from AHRQ's
Effective Health Care program. That program represents the first federal
effort to compare alternative treatments for significant health conditions
and make the findings public. The program is intended to help patients,
doctors, nurses, and others choose the most effective treatments.
Information on the program, including full reports, can be found at
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