[Mari]

Hello,

Has anyone else noticed the new Abilify commercials on television every 20 minutes?

I looked up info on the med and see that it was just approved for children with BP I .

Mari


http://www.medicalnewstoday.com/articles/99195.php

ABILIFY Approved For Acute Treatment Of Bipolar I Disorder In Patients 10 To 17 Years Old

03 Mar 2008 - 3:00 PDT

Otsuka Pharmaceutical Co., Ltd. and Bristol-Myers Squibb Company (NYSE: BMY) has announced that the U.S. Food and Drug Administration (FDA) approved the supplemental New Drug Application for ABILIFY® (aripiprazole) for the acute treatment of manic and mixed episodes associated with Bipolar I Disorder, with or without psychotic features in pediatric patients (10 to 17 years old).

ABILIFY has been approved for the acute and maintenance treatment of manic and mixed episodes associated with Bipolar I Disorder with or without psychotic features in adults since September 2004 and March 2005, respectively.

"Pediatric bipolar illness is a serious condition," said Christoph Correll, M.D., Medical Director, Recognition and Prevention Program, The Zucker Hillside Hospital and Assistant Professor of Psychiatry and Behavioral Sciences, Albert Einstein College of Medicine, Glen Oaks, New York. "The availability of an additional treatment option that can help guide decisions in managing Bipolar I Disorder in children and adolescents is welcome news."

The approval is based on results from a four-week, multicenter, randomized, double-blind, placebo-controlled study in pediatric patients (10 to 17 years old) with Bipolar I Disorder that demonstrated efficacy with ABILIFY compared to placebo on the primary efficacy endpoint, mean change from baseline to Week 4 on the Young-Mania Rating Scale (Y-MRS) Total Score.

[bizi]

http://psychcentral.com/blog/index.p...ch=1&s=abilify

Bristol-Myers Squibb to Pay More Than $515 Million to Resolve Allegations

by John M. Grohol, Psy.D.
October 1, 2007

On Friday, the U.S. Department of Justice announced a landmark
over one-half billion dollar settlement with Bristol-Myers Squibb based, in part, on their marketing of Abilify, a fairly commonly prescribed antipsychotic used in the treatment of schizophrenia and bipolar disorder. It was a settlement a long time in coming, announced originally in December 2006.
Not surprisingly, BMS had little to say about the announcement. The original December 2006 announcement gave some idea of what the settlement would entail, at least from a dollar perspective. But the DOJ press release goes into the juicy details that BMS has been mum about.
So this puts a formal end to the investigation, and BMS is merely $515 million poorer. Although I’m not sure I’d use the word “poor” to ever describe a company that brings in nearly $18 billion in 2006 revenues ($1.6 billion in profit), making it the 6th largest pharmaceutical in the world. That means they had to give up a third of their profits for 2006. Luckily they still made a billion for their efforts.
Abilify is recommended by most of our members who take it and have rated it, and appears to be fairly well-tolerated among the antipsychotics. That’s why these allegations are all the more difficult to understand. If Abilify is a good drug for bipolar and schizophrenia, which we believe it is, why the need for all of the off-label sales tactics?
The allegations related to Abilify were:

Second, the Government alleged that, from 2002 through the end of 2005, BMS knowingly promoted the sale and use of Abilify, an atypical antipsychotic drug, for pediatric use and to treat dementia-related psychosis, both “off-label” uses.[…] Nonetheless, BMS directed its sales force to call on child psychiatrists and other pediatric specialists, and the sales force then urged physicians and others providers to prescribe Abilify for pediatric patients. BMS also created a specialized long term care sales force that called almost exclusively on nursing homes, where dementia-related psychosis is far more prevalent than schizophrenia or bipolar disorder.

Honestly, I’m not sure how a company of this magnitude could, for 3 years!, think that this kind of behavior was “okay” and not going to come under scrutiny. It is exactly this kind of unfortunate behavior that paints the entire pharmaceutical industry with a singular, often-negative brush.

Will this have a chilling effect on both BMS and the rest of the industry from engaging in these kinds of practices in the future? Gosh, one would hope. Because if a half-billion dollars isn’t going to make a statement, I’m not sure what will.

[mrsD]

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:

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].

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.

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.

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.

[Pamster]

I am really scared now, I saw the commercial and it talks about extremely high blood sugar levels causing DEATH or coma! I think I want off this drug, been using it sucessfully for years now but freaking out over the possibility of dying becaue I want to have clear thoughts...I could cry it's so frightening. Should I get off this drug because I am a borderline diabetic? I think so...

[mrsD]

you could test yourself at home to see if you have elevations.

They may only occur after eating.
You can have a blood test A1c done to show if over time you have poor
glucose control. (this is often better than just one blood fasting glucose test)

Certainly you should discuss this with your doctor.
Zyprexa is the worst offender for blood sugar issues. The newer agents
Abilify and Seroquel, haven't had the time on the market to show this effect
clearly. However, the blood sugar issues do happen.

Sometimes life style can control blood sugar issues. And also it may be dose
dependent, and if you have a genetic history tending toward diabetes.

Most people over 40 have some degree of insulin resistance, and not all of them go on to develop frank Type II diabetes. There are many other factors
that must be present.

You may not have to change. But then unless you watch for it, elevated glucose can sneak up on you.

[Pamster]

I am getting an A1c Test done next round of bloodwork because my fasting blood sugar was 100. I am just worried Abilify might be making me become Type II diabetic. It runs in my family and I am turing forty this year. My Mother is having trouble with her blood sugar now that she hit sixty, her fasting blood sugar is 148 and there abouts. Terrible.

We just started an exercise program about two months ago and about a week ago we started juicing, like raw fresh juices from an extractor. I have hope I can undo damage begun, but if it's inevitable that it will elevate my levels of glucase I just might need to get off Abilify. I am so scared now. Jack my DH is all upset about it and upset with me for 'not researching the drugs I take better' which I guess is true, but even so, I am still kinda of freaking out about this since seeing the new commercial.

[mrsD]

some supplements enhance insulin sensitivity.

r-lipoic acid 100mg/day
Chromium 200mcg/day
Taurine 1 gram a day
Cinnamon extract (but typically 2-6grams a day)

May all help keep sugars down. They have to be used with caution in those
already on some diabetic medication.

Another is an herb, but I have little experience with it.
G.Sylvester

[Mari]

Dear Pam,

Be careful about getting excited about a med that is working for you.
Now I am sorry that I posted this.

I became aware of all these commercials and wondered what was up.
Nothing has changed about the drug itself -- only the company's permission to market it to children.


You can be calm about this:
-you are being careful about what you eat
-you are exercising
-you have plans to get your blood sugar checked.
These are all good things.

Do you have access to a bood sugar monitor at home?

Mari

[Pamster]

Oh thank you MrsD, I appreciate the herb/supplement info, I think I might be lucky and be able to avoid this problem and still use Abilify sucessfully for some time. I just don't want to go into Diabetes II because of my desire to be able to have coherent thinking instead of the jumbled mess I existed with for thinking.

Please don't feel that it was you posting this today that set me off Mari, I had seen the commercial twice and was GOING to post something about my fears if this thread hadn't already been posted. So please don't feel bad. I have to admit I overreated a bit because of Jack's fear of losing me to a diabetic coma, but it runs heavily on my mother's side of the family and it scares me, but not due to anything you posted.

This also affects my family in that Jackie was taking abilify for a few years too and I don't think it helped him much. We'd have been better sticking with Risperdal which he took to begin with, I think. It is a criminal thing to use the public as free guinea pigs for their off label prescribing of drugs.

[mrsD]

from our Health News forum today...

Use of CellCept in women off label for lupus and RA---

Birth defects!
http://news.yahoo.com/s/ap/20080516/...ing_roche_drug