very similar to the situation that Pfizer was cited for in promoting
experimental use of Neurontin in massive doses for pain and bipolar in the doctor's offices, rather than running a study.
They paid a fine in excess of $650million, after a whistle blower within the
company revealed this abuse.
The Abilify problem is serious, because the elderly have increased mortality
using this drug and its other atypical cousins.
There is a black box warning from FDA regarding this:
Quote:
WARNINGS
INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS and SUICIDALITY AND ANTIDEPRESSANT DRUGS
Elderly patients with dementia-related psychosis treated with atypical antipsychotic drugs are at an increased risk of death compared to placebo. Analyses of seventeen placebo-controlled trials (modal duration of 10 weeks) in these patients revealed a risk of death in the drug-treated patients of between 1.6 to 1.7 times that seen in placebo-treated patients. Over the course of a typical 10-week controlled trial, the rate of death in drug-treated patients was about 4.5%, compared to a rate of about 2.6% in the placebo group. Although the causes of death were varied, most of the deaths appeared to be either cardiovascular (eg, heart failure, sudden death) or infectious (eg, pneumonia) in nature. ABILIFY (aripiprazole) is not approved for the treatment of patients with dementia-related psychosis [see WARNINGS and PRECAUTIONS].
Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of Major Depressive Disorder (MDD) and other psychiatric disorders. Anyone considering the use of adjunctive ABILIFY or any other antidepressant in a child, adolescent, or young adult must balance this risk with the clinical need. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24; there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and older. Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide. Patients of all ages who are started on antidepressant therapy should be monitored appropriately and observed closely for clinical worsening, suicidality, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber. ABILIFY is not approved for use in pediatric patients with depression [see WARNINGS and PRECAUTIONS].
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http://www.rxlist.com/cgi/generic/abilify.htm
Because some of the atypical antipsychotics act like antidepressants on the serotonin system, the warnings for children are included in the black box.
Quote:
Pharmacodynamics
Aripiprazole exhibits high affinity for dopamine D2 and D3, serotonin 5-HT1A and 5-HT2A receptors (Ki values of 0 .34 nM, 0 .8 nM, 1.7 nM, and 3.4 nM, respectively), moderate affinity for dopamine D4, serotonin 5-HT2C and 5-HT7, alpha1-adrenergic and histamine H1 receptors (Ki values of 44 nM, 15 nM, 39 nM, 57 nM, and 61 nM, respectively), and moderate affinity for the serotonin reuptake site (Ki=98 nM). Aripiprazole has no appreciable affinity for cholinergic muscarinic receptors (IC50 > 1000 nM). Aripiprazole functions as a partial agonist at the dopamine D2 and the serotonin 5-HT1A receptors, and as an antagonist at serotonin 5-HT2A receptor.
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Antipsychotics are dangerous in the elderly population. However, they are still used there. ( I used to work at a long term care provider of medications).
What this news item reveals, is the basic abuse the drug industry is engaging in. Using the sales force to promote off label use, or extremely high dosing as in Neurontin, without doing formal safety studies as required by the FDA.
In the case of Neurontin, the sales people were given ACCESS to the patients during their visit to the doctor even...which is just unheard of and a violation of privacy and confidentiality.
The general public is NOT fodder for experiments. Large scale experiments!
If a physician choses to go off label for something, that is his/her responsibility, and the patient can hold them accountable thru the legal system if damage is done. Wholesale experimentation on a grand scale to improve profits is abusive IMO.
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All truths are easy to understand once they are discovered; the point is to discover them.-- Galileo Galilei
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Weezie looking at petunias 8.25.2017
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