Selling Our Children to the Pharmaceutical Industry - PBS reports

Selling Our Children to the Pharmaceutical Industry - PBS reports

Have we sold our kids to the pharmaceutical Industry? This PBS report appears to be evidence that foster kids have been not just used, but abused as cash cows for exactly this purpose...corrupted doctors who have forgotten they took an oath to do no harm, not to profit as much as possible. Medicine has lost it's way, and they are not going to change direction until we make them change direction. Watch this video and then read this supposed Sham  Torture study in 4 to 6 year old toddlers using seroquel. This is a precursory study leading to a much larger study planned in the future.
Yes, you could have guessed that it was directed out of Massachusetts General Hospital ( Janet Wozniak, MD ). Most in the know consider this Harvard University affiliated Hospital the center and birth place of the "BIPOLAR CHILD" Myth.

Please keep in mind as you read this study that there is no stated criteria for preschool bipolar disorder in the DSM-IV. The well funded Pharmaceutical Industry shill doctors @ Harvard created this criteria out of thin air to get drug approval from the FDA. Then using this witchcraft logic, come to the conclusion that the if the FDA approves the drug, then there must be a validated disease?

I have a really hard time following this sick and twisted bullshit logic that is putting thousands upon thousands of our children at dire risk; but I guess when billions of dollars in profits are at stake...Magic is made possible...

Watch the full episode. See more Need To Know.

http://clinicaltrials.gov/pediatric+quetiapine

 Quetiapine for Mania In Preschool Children 4 to 6 Years of Age With Bipolar Disorder

This study has been completed. 

 Purpose

This is an 8-week open-label study aimed at assessing the effectiveness and tolerability of Quetiapine, in the treatment of preschool children aged 4 to 6 years with bipolar and bipolar spectrum disorder. This is an exploratory, pilot study, seeking to determine whether Quetiapine is efficacious and well tolerated in the treatment of preschoolers with pediatric bipolar and bipolar spectrum disorder in this age group. The study results will be used to generate hypotheses for a larger randomized controlled clinical trial with explicit hypotheses and sufficient statistical power.

Official Title: Open-Label Study of Quetiapine for Mania In Preschool Children 4 to 6 Years of Age With Bipolar and Bipolar Spectrum Disorder

Primary Outcome Measures:

• reductions in symptoms measured by [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
• Young-Mania Rating Scale (Y-MRS) [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
• Mania Symptom Checklist [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	20
Study Start Date:	February 2005
Study Completion Date:	April 2009
Primary Completion Date:	April 2009 (Final data collection date for primary outcome measure)

Intervention Details:

Drug: quetiapine (Seroquel)
2.5 - 5.0mg/kg PO BID quetiapine

Detailed Description:

Seroquel is a psychotropic agent that affects multiple neurotransmitter receptors in the brain: serotonin 5HT1A and 5HT2, dopamine D1 and D2, histamine H1 (IC50=30nM), and adrenergic receptors.

This is an 8-week open-label study aimed at assessing the effectiveness and tolerability of Quetiapine, in the treatment of preschool children aged 4 to 6 years with bipolar and bipolar spectrum disorder. This is an exploratory, pilot study, seeking to determine whether Quetiapine is efficacious and well tolerated in the treatment of preschoolers with pediatric bipolar and bipolar spectrum disorder in this age group. The study results will be used to generate hypotheses for a larger randomized controlled clinical trial with explicit hypotheses and sufficient statistical power.

  Eligibility

Ages Eligible for Study:	4 Years to 6 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

• Male or female subjects, 4-6 years of age.
• Subjects must have a DSM-IV diagnosis of bipolar I, bipolar II disorder or bipolar spectrum disorder and currently displaying manic, hypomanic, or mixed symptoms (with or without psychotic features) according to the DSM-IV based on clinical assessment and confirmed by structured diagnostic interview (Kidd Schedule of Affective Disorders and Schizophrenia Epidemiological Version). Bipolar spectrum disorder (or sub-threshold bipolar disorder) is operationalized as having severe mood disturbance, which meets DSM-IV Criteria A for bipolar disorder but meet fewer elements in criteria B (only require 2 items for elation category and 3 for irritability).
• Subjects and their legal representative must have a level of understanding sufficient to communicate intelligently with the investigator and study coordinator, and to cooperate with all tests and examinations required by the protocol.
• Subjects and their legal representative must be considered reliable.
• Each subject and his/her authorized legal representative must understand the nature of the study. The subject's authorized legal representative must sign an informed consent document.
• Subjects must have an initial score on the Y-MRS total score of at least 20.
• Subject must be able to participate in mandatory blood draws.
• Subjects with comorbid ADHD, ODD, CD, anxiety and depressive disorders will be allowed to participate in the study provided they do not meet for any of the exclusionary criteria.
• For concomitant stimulant therapy used to treat ADHD, subjects must have been on a stable dose of the medication for 1 month prior to study enrollment. The dose of the stimulant therapy will not change throughout the duration of the study.

Dr. Charles Schulz , University of Minnesota, Dan Markingson and the Seroquel CAFE study--the UMN says no further discussion, calls Carl Elliott a 'crusader'

Journalist William Heisel asks University of Minnesota's Dr. Charles Schulz for interview-no reply--PR says no more discussion of Dan Markingson's case, and calls Carl Elliott a crusader against the University and Dr.Charles Schulz.


Schulz, was the principal investigator in the CAFE study of Seroquel, which hangs over the University as a dark cloud, due to the death--suicide--of Dan Markingson.

Heisel, in persuit of a more detailed discussion with Schulz, never heard from Dr.Schulz (who is currently overseeing a Seroquel XR trial for Borderline at the UMN), but did receive an email from the public relations department representative. What transpired in that email essentially demotes Carl Elliott, a bioethicist at the University of Minnesota into a one-man crusader against the University and Dr. Schulz. The University has taken a stand now, that no more discussion is necessary regarding the death of Dan Markingson, in fact the UMN is attempting to disconnect the death and the trial, all of it.

Red flag alert! if the University has nothing to hide then why not talk? attempting to bury the discussion runs along the same lines as AstraZeneca burying the Study 15 for Seroquel, or the hiding of the diabetes and weight gain side effects as AstraZeneca did for years.

Why is the University allowing a placebo vs. Seroquel XR trial for Borderline Disorder? the drug is already on the market, and against a placebo? sounds like another patent extender indication, get them all approved before the drug goes generic and off patent.

Why won't Schulz talk? they've all decided this is no longer worthy of mass media attention. Who decides that?

Read William Heisel's article here-at the Reporting on Health blog. "The Markingson Files: University of Minnesota dallies on clinical trial documentation". Besides the lack of interviews the UMN is also dragging their feet sending Heisel documents, in essence it appears the UMN has flipped the bird at Heisel and anyone else interested in the Markingson case, and Schulz and AstraZeneca Seroquel trials are business as usual, nevermind that Schulz has in the past has received income from AstraZeneca.

No conflict of interest there......

Phaco Chop With Ozil

I really like to use the Alcon Infinity Ozil system for phaco chop.  i think there are 3 distinct phases to phaco chop with the ozil and they are outlined below:

Chop Phase. In this phase we are chopping the nucleus into 6 pieces.  I like to start using longitudinal ultrasound (no Ozil) as i think the side to side motion of the Ozil does not allow one to occlude as tightly as when you use longitudinal ultrasound.  I recommend a high fixed aspiration flow rate (AFR) and high fixed vacuum cut off.   By fixed i mean that no matter where i am in position 2 or 3 of the foot pedal the vacuum and AFR are the same.   I usually have the AFR at about 30-35 and the vacuum cut off at about 300-350. This will require a fairly high bottle height 90-110 to keep surge to minimum depending on how much fluid you are losing around the wound.  You will need to adjust the longitudinal ultrasound power depending on the density of the nucleus (40-80%).   I like to use either a burst setting or a 4 Hz frequency pulse (Dr Howard Fine coined the term choo choo chop as it sounds like a train).   I like to use a horizontal chop for the intial crack and then a sort of hybrid horizontal and vertical to break the halves in 6 pieces.   I like the Siebel Chopper as shown in the video below

When doing the initial phaco chop (assuming you are right handed) you want the left side of the completely embeded phaco needle to be in the center of the lens.    Then imagine a line drawn from the left side of the phaco needle out to the periphery of the lens under the cpasule.  this is the line of the chopper as it slices through the lens.   As you chop toward the needle (horizontal chop) and get just to the left side of the phaco needle lift up a bit on the needle and push down a bit on the chopper (vertical chop) as you simultaneously also push the instruments away from each other.  (best learned from video below).  After the nucleus is divided in half with the initial chop rotate the lens clockwise about 60 degrees to begin to break each half into thirds.  The chopping is similar for the halves except i usually dont go out so peripheral and accentuate the vertical part of the motion over the horizonal.  I usually try to break each half into thirds or 6 pieces total.  

Segment removal phase. After the lens is chopped into 6 pieces I switch to the Ozil mode.   Similar to the chopping settings, I like a high fixed AFR and fixed vacuum for this mode.   I usually have the AFR at about 30-35 and the vacuum cut off at about 300-350 with a continuous Ozil at 70-100%.  The side to side motion of the Ozil creates less repulsive force than the longitudinal ultrasound and the material really flows into the tip and out of the eye.   If you encounter a very hard nucleus you may need to add in some longitudinal phaco power to keep the tip from occluding as it sometimes does with only Ozil.

Shizzel phase.   After the nucleus is removed you often have some epinuclear material left over.  I like to switch to a low setting of Ozil (<40%) with linear control of the AFR (max at 30-35) and vacuum (max at 300-350).   By linear I mean that the harder I push the pedal into position 2 the more AFR and higher vacuum cut off I get.   This mode gives you very fine control (venturi like) when grabbing the delicate epinuclear material helping to prevent you from swiss cheesing through it to the bag.  Shizzle is a term coined by Drs Graff and Friedrichs of Iowa that refers to holding the epinuclear material high with the phaco while sweeping under to push out the subincisional material (the Shizzel is best appreciated on video).

Here is the video of Ozil phaco chop.

Learning phaco chop is best done in steps or stages.   Start by simply getting used to having the chopper in the eye while doing divide and conquer.  Then transition to chopping parts of the lens like a quarter or a half as in stop in chop.  The white cataracts are great for your first chop cases as they are brittle and easily chop and as the delicate capsule is easy to see with the Trypan stain. 

Here is a video outling some of the steps to learning phaco chop

Anterior vitrectomy

Vitreous can be very difficult for the anterior segment surgeon. when it presents we can be tempted to take short cuts which can lessen the safety of our surgery. being prepared is your best defense and here i will present a few tips based on my experience with the vitreous.

The cause of vitreous prolapse in your case is important as it may guide your surgical reatment and IOL location. A capsular tear can cause vitreous prolapse with an anterior tear extending posteriorly probably being most common. Primary posterior tears from the phaco needle being too deep or from a strike from the I/A device or another instrument are also common. It is best to find a cause which does not involve the surgeon such as a tear extending from a preexisting weakness from a posterior polar cataract, iatrogenic (different surgeon) from pars plana vitrectomy, or from penetrating lens trauma. Besides tears zonular dialysis can lead to vitreous prolapse and can come from your surgery with forceful rotation or pulling on the capsule with the I/A or from pre-existing conditions such as trauma, PXF, or Marfan’s.

For me the first sign of vitreous prolapse is denial. I begin to think that something is not right but and find lots of reasons why everything is really OK. denial is a powerful force for me. More objective signs of vitreous loss are the chamber suddenly deepens, the pupil widens, the residaul lens lens material is no longer centered or doesnt spin, lens particles no longer come to the phaco needle, and a big sign would be lens particles sink to the back of the eye.

3 basic principles of vitrectomy are to 1) go bimanual with separate irrigation and cutting devices, 2) close the chamber, and 3) cut low and irrigate high. if you follow these 3 principles you can keep most of the vitreous out of the front of the eye and away from the wound, iris, cornea where it can cause so much trouble. most importantly you can help to limit the amout of vitreous expression and its risk of retinal detachment.

go bimanual with separate device for irrigation and cutting is fairly easy now as most machines will allow this or assume this from the start. some machines such as the alcon 10,000 had a coaxial device and you had to remove a sleeve to make it bimanaul. i like to use a 23 gauge cortex extractor cannula to irrigate with the cutter usually in my dominant hand.

close the chamber so that no fluid can get out with the vitrectomy instruments in the eye. this will require you typically to close your main incision and add a paracentesis if you are doing traditional coaxial phaco. through one paracentesis you will place your irrigation cannula and through another larger paracentesis you will place your vitreous cutter/aspirator. if you use a 3.0 mm or similar phaco wound for the vitreous cutter apsirator the chamber will not be controlled and fluid and vitreous will stream through this wound around the cutter. you need to make the area of least resistance for any fluid or vitreous to leave the eye be the aspiration/cutter device. see the video showing the importance of closing the chamber to control the flow of vtreous.

With control of the chamber and bimanual instruments you can cut low and irrigate high. You will want to have the cutter/aspirator low to get at the root of the vitreous while irrigating high in the closed chamber to create a fluid pressure differential to push the vitreous toward the cutter. if you irrigate in the area of the cutter/aspirator you may push the vitreous away from the cutter and even worse more anterior toward the wound. in this video you can see the use of the 3 principles to remove the vitreous and some residual cortical material.

there are 3 basic phases in the case when vitreous presents: early in the case with most of the crystalline lens in the eye, with only some cortical material left (most common), and while placing the IOL.

When vitreous presents early during nucleus removal clean up is the most difficult. the vitreous is often entwined in the nuclear pieces. it can be very difficult to get posterior enough with the cutter to cut off the vitreous at its source with all of the nuclear pieces in the way. and most importatnly it is hard to not bump the pieces through the capsular tear to fall south into the back of the eye. you have a big decision to make right up front: convert to ECCE or not. if the nucleus is hard and mostly in one piece i would strongly consider converting the a large incision ECCE. the video below outlines the issue with conversion to ECCE and ther steps are listed below:

• If topical do subtenons injection
• Close temporal incision and create standard ECCE superiorly (or extend existing wound)
• Have Wescott scissors ready when looping out lens to cut vitreous
• Close with 2 vicryl safety sutures
• Anterior vitrectomy, Weck cell vitrectomy
• Dry removal of residual cortical material with syringe on 27 gauge cannula
• Use J-cannula if needed for subincisional material
• Consider staining with preservative free dilute kenalog
• Place IOL if possible in sulcus or AC (if AC, don’t forget peripheral iridotomy)
• Miochol to bring pupil down—seats sulcus IOL, peaked pupil helps to detect vitreous

Sometimes even with early loss of vitreous with nuclear material left you can carefully proceed with phacoemulsification. the key is to provide some separation between the space with vitreous and the area of phacoemulsification. the pace is slowed down with a low bottle height and low vacuum (Osher slow motion phaco). here are the steps.

• Seal off capsular hole with liberal use of viscoat (cohesive OVD will not work)
• Keep phaco occluded in the lens as much as possible to avoid pulling on the vitreous
• Lower the vacuum and bottle height
• Consider using a sheets glide to seal off hole -- trap nucleus in AC
• Work with one or two large pieces (rather than chopping into many small bits that can more easily fall south

The most common time for vitreous is while removing the last bit of nuclear material or during cortical removal. The main emphasis during this phase is to remove any residual cortical material following vitrectomy. loss of small amounts of cortical material to the back of the eye or leaving small amounts in the anterior segment will often present no difficulty. Preserving capsule for lens placement in the sulcus is important also. the steps when vitreous comes in this phase are:

• Place viscoat in area of tear or dialysis before removing instruments
• as always split into irrigating cannula (eg. 23g. cortex extractor) and the vit cutter (w/o sleeve)
• Suture wound and use two paracenteses one for the cutter and one for irrigating cannula
• Irrigate high and cut/suck low – creates a pressure gradient to push the V back
• Settings low vacuum 100 range, low bottle height 50 range, max cut rate
• Dry removal of residual cortical material with syringe on 27 gauge cannula
• Use J-cannula if needed for subincisional material
• Consider staining with kenalog (see below)
• Place IOL if possible in sulcus (see video below) or AC (if AC don’t forget peripheral iridotomy)
• Miochol to bring pupil down

The least common time for vitreous is while placing or just after placing the IOL. Usually in this phase very little vitreous comes forward. the main issues surround the IOL. will it be stable in the bag or should the IOL (or often an appropriate IOL) be placed in the sulcus. here are the steps for dealing with vitreous in this phase and a video showing this situation.

• Stabilize the IOL by placing one haptic out of the wound or in the AC
• Anterior vitrectomy as described above – attempt to get the cutter below the IOL
• Place both haptics in the sulcus if possible (cannot use SA60 in sulcus consider alt fixation)
• Use weck cell sponge to ensure wound is clear
• Consider stain
• Miochol to check pupil

Most patients who have an anterior vitrectomy do very well. it is important to be honest with the patient about what happened. i usually tell them:

"the thin membrane that surrounds the cataract tore during surgery. I had to take some extra time to remove the gel from the back of the eye. I was able to remove all of the cataract and place the artifical lens. i think everything is going to be great but i will have to watch you a little more closely for a while"

In summary the most important thing to remember with anterior vitrectomy is to control the chamber and use bimanual instrumentation.

Seroquel - more deadly side effects - another one the FDA tried to bury

Here we go again: another deadly side effect from Seroquel that was mass marketed touted as less deadly safer and more effective than nothing those older anti-psychotic drugs that were to deadly dangerous to mass market to the general population. We now know it was all lies hype and bullshit marketing; in fact this drug is not only no safer or more effective than it's predecessors, it appears to be even more dangerous.

Of course when you have the FDA in your pocket, it takes even longer for the public to become aware of the potential dangers and side effects associated with seroquel use. In Fact the FDA in April 2011 told POGO  that no new warning were in the offing for seroquel. So without public fanfare the FDA releases this new warning yesterday.

From the NYTimes

Heart Warning Added to Label on Popular Antipsychotic Drug

By DUFF WILSON Published: July 18, 2011 

AstraZeneca is adding a new heart warning to the labels of Seroquel, its blockbuster antipsychotic drug, at the request of the Food and Drug Administration, company and agency officials said on Monday.

Warnings for Seroquel will soon recommend that the drug be avoided in combination with 12 drugs linked to arrhythmia.

The revised label, posted without fanfare last week on the F.D.A. Web site, says Seroquel and extended-release Seroquel XR “should be avoided” in combination with at least 12 other medicines linked to a heart arrhythmia that can cause sudden cardiac arrest.

Sandy Walsh, a spokeswoman for the F.D.A., said the statement was only a precaution for doctors, and should not be considered a complete ban against prescribing Seroquel with the other drugs.
Ms. Walsh said the label was changed after the F.D.A. received new information about reports of arrhythmia in 17 people who took more than the recommended doses of Seroquel. Though it should not be a problem at a normal dosage, she said, it may still be good advice to avoid using the drugs together.

The arrhythmia, known as prolongation of the QT interval, referring to two waves of the heart’s electrical rhythm, is estimated to cause several thousand deaths a year in the United States.


As AstraZeneca prepares to report its second-quarter earnings at the end of this month, it faces additional scrutiny this week. The F.D.A. is considering the London-based company’s dapagliflozin, a proposed diabetes drug with Bristol-Myers Squibb, and is expected to decide soon on Brilinta, an anticoagulant. The company is facing the loss of patents for Seroquel next year and for the heartburn drug Nexium in 2014.

Seroquel is one of the top-selling drugs in the world, at $5.3 billion last year, including $3.7 billion in the United States. Introduced in 1997, it has been approved for schizophrenia, bipolar disorder and severe depression. Seroquel has caused legal problems for AstraZeneca, including a $520 million payment in 2009 to settle government charges of illegal marketing. Thousands of lawsuits are pending over side effects like diabetes.

The previous Seroquel labels had mentioned the risk of a prolonged QT interval, but had not identified other drugs to avoid, Stephanie Andrzejewski, a spokeswoman for AstraZeneca, said Monday. The new warning also is separated from other warnings and precautions on the label, she said, “to provide some additional guidance to physicians” treating patients ”who are already at risk of QT prolongation.”

The new warning will be added to printed labels as soon as possible, Ms. Andrzejewski said.
The new label lists the other drugs to avoid as antiarrhythmic drugs like quinidine, procainamide, amiodarone and sotalel; antipsychotic drugs like ziprasidone, chlorpromazine and thioridazine; antibiotics like gatifloxacin and moxifloxacin; the anti-infective drug pentamidine; and synthetic opioids like levomethadyl acetate and methadone. The label also raises caution about use by the aged and people with heart disease.


James J. Pepper, a lawyer in Pennsylvania who is involved in drug litigation, has been arguing for months in letters to government officials that Seroquel has a potentially deadly interaction with methadone in regard to the QT interval.

“This is a huge, huge step,” Mr. Pepper said of the label change, though he said he thought it should be stronger.


Ms. Walsh said the F.D.A. action was unrelated to Mr. Pepper’s arguments.


Three months ago, Dr. Janet Woodcock, director of the F.D.A. Center for Drug Evaluation and Research, rejected those arguments in a letter to the Project on Government Oversight, a nonprofit group in Washington, which had also raised the issues. Dr. Woodcock wrote that a thorough agency review had found it “exceedingly unlikely” that patients faced an unreasonable risk from the interaction between Seroquel and methadone. The review found only one death that was probably caused by the interaction, she wrote.

Dr. Woodcock concluded that the F.D.A. would take no action to change the label. Ms. Walsh said that conclusion was still correct, because the F.D.A. had found no biological basis for a problem or unusual numbers of deaths at normal dosages.

____________________________________

From POGO Blog

Paging Dr. Woodcock...Dr. Janet Woodcock....Do You Have Any Clue What's Happening Inside the FDA?

By PAUL THACKER

There is confusion and then there is confused confusion--a level of incomprehensibility that defies sound, sober attempt at explanation. After confused confusion comes...the FDA.

Case in point: the FDA's dithering over changes to the label of an antipsychotic drug now widely prescribed to veterans with post-traumatic stress disorder. Last October, POGO sent a letter to FDA Commissioner Margaret Hamburg asking her to look into a potentially dangerous interaction of the drugs Seroquel (quetiapine) and methadone that may be putting veterans at risk.

Prescriptions of Seroquel and methadone are at an all-time high for veterans who are suffering extremely high rates of PTSD after combat. An investigation by the Military Times found that military spending on Seroquel almost quadrupled between 2001 and 2009. Many of these veterans are also taking methadone for pain relief and to control anxiety caused by PTSD. The Military Times found that methadone overdose has caused at least 60 deaths in the military—more than any other drug, legal or illegal.

A separate investigation by the Associated Press noted that military expenditures on Seroquel have jumped sevenfold since the beginning of the war in Afghanistan. The military spent $8.6 million on Seroquel in 2009. Physicians said that they are prescribing it to provide relief from nightmares and anxiety caused by PTSD.

The Associated Press also discovered that Seroquel has become the Department of Veterans Affairs' (VA) second biggest drug expenditure since 2007. In 2009, the VA spent $125 million on Seroquel compared to $14.4 million in 2001.

Alerting the FDA to this problem, we also sent a study published in 2007 in the Journal of Clinical Psychopharmacology. This study found that Seroquel significantly increases blood plasma levels of methadone.

How did FDA respond? In April, we received a letter signed by Dr. Janet Woodcock, Director of the Center for Drug Evaluation and Research (CDER) at the FDA. According to Dr. Woodcock, there was nothing to worry about:

After assessment of our evaluations, we believe that a potentially dangerous interaction involving quetiapine and methadone is unlikely, and, therefore, no further Agency action is indicated regarding either a revision in labeling that would include new warnings or cautions, or targeted public and professional communications efforts.

To make sure we got the point, she added:

At this point, there is agreement within CDER that an interaction between quetiapine and methadone that confers unreasonable risks to patients is exceedingly unlikely and, therefore, no further action is indicated regarding the labeling for these products or for related communication initiatives.

Less than two months later, in June, the FDA approved changes to the label for Seroquel to note that the drug “should be avoided in combination with other drugs” such as methadone.

What the hell? This is exactly what we asked them to do. Exactly what Dr. Woodcock said didn’t need to be done.

Can somebody please explain this to me? Please!

Anyways, we are now sending a second letter to the FDA asking them, as we did in October, to please issue an action alert to inform patients and prescribers. There is a potential for people to die if they are on Seroquel and methadone, and it seems highly improbable that a military doctor treating veterans with PTSD has the time to read the entire 73 pages of the Seroquel label.

That’s right. It's 73 fricking pages!!!
That’s not a label, that’s a novella.

We hope the FDA agrees to send out an action alert. But maybe we’ll get a letter from Dr. Woodcock saying that everything is okay, and no further action is indicated…and there’s no need to alarm people by sending out an action alert….

And then they’ll send it anyways.

Paul Thacker is a POGO Investigator.

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From soulful sepulcher blog

AstraZeneca's antipsychotic SEROQUEL: new label revision includes risk of sudden death-QT prolongation

Still interested in taking the antipsychotic Seroquel for insomnia off-label? think again, know your medications, this is not a sleep aid. (and it's not an antidepressant)


Seroquel label fine print pdf click here:

• QT Prolongation: Post-marketing cases show increases in QT interval in
patients who overdosed on quetiapine, in patients with concomitant illness, and in
patients taking medicines know to cause electrolyte imbalance or increase QT
interval. Avoid use with drugs that increase the QT interval and in patients with
risk factors for prolonged QT interval.


What is QT Prolongation?


QT Interval:


"In cardiology, the QT interval is a measure of the time between the start of the Q wave and the end of the T wave in the heart's electrical cycle. In general, the QT interval represents electrical depolarization and repolarization of the left and right ventricles. A prolonged QT interval is a biomarker for ventricular tachyarrhythmias like torsades de pointes and a risk factor for sudden death."-wikipedia



The label changes listed on the info prescribing sheet


RECENT MAJOR CHANGES

Warnings and Precautions, Hyperglycemia (5.4), 1/2011

Warnings and Precautions, Hyperlipidemia (5.5), 1/2011

Warnings and Precautions, Weight Gain (5.6), 1/2011

Warnings and Precautions, QT prolongation (5.12), 6/2011

Warnings and Precautions, Hypothyroidism (5.14), 1/2011

Warnings and Precautions, Withdrawal (5.23), 05/2010


This is an antipsychotic, not an antidepressant, not a sleep aid, it was created for psychosis treatment and is now off-label used and being approved for just about everything imaginable. At what cost does AstraZeneca milk this patent? this is a potent neuroleptic and note that there are withdrawals warnings in the fine print also...

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George Carlin had it right...."they got you by the balls"