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FDA: Meeting 9th & 10th June re 'safety' of antipsychotics for children

June 8 2009 at 11:44 AM
ZYPREXA. SEROQUEL, GEODON for children?...... 

FDA GOV DOC: DRUGS ADVISORY COMMITTEE 

(PDF FILE)

Link found in this article:

 

http://blogs.wsj.com/health/2009/06/05/fda-sees-benefits-risks-in-antipsychotics-for-children/

June 5, 2009, 3:17 PM ET

FDA Sees Benefits, Risks in Antipsychotics for Children

By Shirley S. Wang

Child taking pillPowerful antipsychotics currently used to treat adults for schizophrenia and bipolar disorder appear to be effective in treating children and teens as well, though there are serious risks associated with the medicines, according to documents put out by the FDA staff today.

AstraZenecas Seroquel, Eli Lillys Zyprexa and Pfizers Geodon are all being considered by the FDA for use in children. A panel of outside experts will meet next week to discuss the risks and benefits of these medicines for use in children and make a recommendation to the FDA.

Though they work at combating serious symptoms such as delusions and hallucinations in schizophrenia, or severe mood swings associated with bipolar disorder, the drugs also appear to induce weight gain and sleepiness, according to Dow Jones.

These risks are of particular concern in pediatric patients because of the life-long nature of these disorders, wrote Thomas Laughren, director of the FDAs psychiatric product division, in a memo.

Recent studies of effectiveness have shown that the antipsychotics arent as good as previously believed. They reduce some symptoms for some people but they help too few people recover, Thomas Insel, director of the National Institute of Mental Health, wrote in an email to the Health Blog. We really need a new generation of compounds that will target the full range of problems in serious mental illness.

Insel said using antipsychotics in children is a tough balance between the risk vs. the benefits of the medicines. With current antipsychotics you risk either metabolic side effects or neurological side effects, he wrote. Sometimes these potentially serious risks are worth the benefit, but in children the balance needs to favor minimizing risks.

Currently only two antipsychotics, J&Js Risperdal and Bristol-Myerss Abilify, are approved for use in children."

 



    
This message has been edited by SSRIAdmin on Jun 9, 2009 9:18 PM


 
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AuthorReply
admin

They 'appear' to be effective in kids despite the deadly risks?

June 8 2009, 11:48 AM 

...Powerful antipsychotics currently used to treat adults for schizophrenia and bipolar disorder appear to be effective in treating children and teens as well, though there are serious risks associated with the medicines, according to documents put out by the FDA staff today.

AstraZenecas Seroquel, Eli Lillys Zyprexa and Pfizers Geodon are all being considered by the FDA for use in children. A panel of outside experts will meet next week to discuss the risks and benefits of these medicines for use in children and make a recommendation to the FDA...

 

Lets hope the panel of outside experts are not as blind as the FDA themselves.


 
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GEODON, SEROQUEL, ZYPREXA for KIDS?.....

Joint statement by groups to influence FOR approved antipsychotics for children

June 9 2009, 12:43 PM 

They already have children on antipsychotics prescribed 'off label' and children have died on these most powerful drugs, and yet 'non profit' groups are still wanting them to be approved for children.

Educational grants for groups, shares, huge fees for consultants such as Joseph Biederman etc, conflicts of interest...all considered NON profit.

Money first, children last.  Millions of American children are prescribed stimulants, antidepressants and antipsychotics (off label) and many have died.  If these groups don't know the risks by now, after all these decades, then surely they're incapable of learning later. Their general message inbetween a lot of bull seems to be that in the meantime they'd like to add to the number of children getting drug induced illness like diabetes, movement disorders, cardiac disorders, suicidality and homicidality by having antispsychotics APPROVED for use in children to ensure more doctors prescribe them.

Where are the groups who genuinely CARE about children?

http://news.prnewswire.com/DisplayReleaseContent.aspx?ACCT=104&STORY=/www/story/06-08-2009/0005040080&EDATE=

Joint Statement on Atypical Antipsychotic Use in Children
 

WASHINGTON, June 8 /PRNewswire-USNewswire/ -- The below listed groups issued the following statement regarding the upcoming FDA Psychopharmacologic Drugs Advisory Committee Meeting on June 9-10:


As advocates for people living with mental illnesses, we strongly urge the FDA to carefully consider the importance of viable treatment options for bipolar disorder and schizophrenia in pediatric and adolescent populations. Access to safe and effective treatments, including more information about all treatment options, is crucial to treating these serious and complex conditions in children and adolescents.


Bipolar disorder and schizophrenia are very real, life-threatening diseases which can appear in childhood and adolescence. For example, federally funded research (STEP-BD) found that, of 3,658 adult patients studied, 68% reported bipolar disease onset in childhood or adolescence. Patients with child onset had, on average, fewer days of euthymia (or neutral mood), greater impairment in functioning and poorer quality of life. Those with adolescent onset have better outcomes than those with child onset, but were still worse off than those who did not suffer from bipolar disorder until adulthood. These alarming statistics highlight the need for early recognition and treatment, which offers children and adolescents their best chance to achieve and maintain wellness.


We encourage an open and transparent scientific discourse about all pharmacologic treatments that come before the Advisory Committee and urge the Committee to carefully weigh the available evidence regarding safety and efficacy. No one treatment option works for all children. In order for physicians and families to make informed treatment decisions they need access to a full range of medications and treatment options and to the research regarding the risks and benefits of these treatments. More long-term clinical research in children and adolescents is also needed to better understand the risks and benefits of these medications when used over an extended period.


As we know, these medications can also have serious side effects, which is why it is crucial that parents and physicians have as much information as possible in order to make informed decisions and weigh the risk of side effects and adverse reactions against the risk of not treating these very serious diseases. Other treatments for grave childhood illnesses such as cancer can cause hair loss, nausea, compromised immune systems and even death. However, few people question the necessity of these aggressive forms of treatment. Like cancer, aggressive treatment may be needed for some patients with bipolar disorder and schizophrenia, diseases with a higher risk of death than some forms of cancer.


The best way to protect the health of our nation's children and adolescents is to increase access to treatment options and communicate accurate, scientific information that helps parents and physicians cope with and properly treat these devastating illnesses.


Our non-profit national mental health advocacy and medical professional organizations represent consumers, physicians, researchers and the top experts in the field of mental health and neuroscience. For more information about mental illness and treatment, we recommend that you talk to your health care provider or visit our organization websites.


American Academy of Child and Adolescent Psychiatry - www.aacap.org

American Foundation for Suicide Prevention - www.afsp.org

American Psychiatric Association - www.psych.org

Child and Adolescent Bipolar Foundation - www.bpkids.org

Children and Adults with Attention-Deficit/Hyperactivity Disorder - www.chadd.org

Families for Depression Awareness - www.familyaware.org

Mental Health America - www.mentalhealthamerica.net

National Alliance on Mental Illness - www.nami.org

National Council for Community Behavioral Healthcare - http://www.thenationalcouncil.org/


SOURCE Mental Health America "

 

 



    
This message has been edited by SSRIAdmin on Jun 9, 2009 9:19 PM


 
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TOO MANY CHILDREN are dying OFF LABEL....

The FDA vote tomorrow. For or against approval of GEODON, SEROQUEL, ZYPREXA for KIDS....

June 9 2009, 1:04 PM 

I can imagine it.

'HANDS UP ALL THOSE FOR APPROVING ZYPREXA, SEROQUEL AND GEODON FOR CHILDREN and keeping in with Eli Lily, Astra Zeneca and Pfizer, particularly at a time like right now when they need more income as they have the stress of having to pay out $billions in settlements all across America for things like criminal fraudulent marketing over those drugs [or in Pfizer's case fighting against Lipitor lawsuits and for paying out settlements for experiments of Trovan on African children] which is why more and more children are already being diagnosed with mental illnesses and given them off label...'

Pause, hand count.

'THATS A MAJORITY SHOW FOR APPROVAL - WELL DONE MEMBERS OF THE FDA for ensuring we remain in the industries' good books by regulating their fraudulent science and drugs just the way they want it.  We'll carry on  ignoring the children who die on approved drugs just like we've done for those who died on off label prescriptions , but lets hope they don't kill  too many off as we really do need the profit from each child for a lifetime, not just for 3 years or a year or 10 years, or a few months. If we get too much criticism, we'll wait  a few years till doctors prescribe them automatically, then we'll add black box warnings they'll never bother to check on to look as if we do our job properly.'

Pours champagne.

"ALL RAISE YOUR GLASSES.  To us and our own futures!'

Mutters all round, turning to victorious cheers.

'To us!  TO US!  TO US!'

 



    
This message has been edited by SSRIAdmin on Jun 9, 2009 9:48 PM
This message has been edited by SSRIAdmin on Jun 9, 2009 9:35 PM
This message has been edited by SSRIAdmin on Jun 9, 2009 9:22 PM


 
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admin

I desperately hope I'm as wrong can be be about the outcome of this vote, but...

June 9 2009, 1:09 PM 

...when do we ever see the FDA put protection of the people before protection of the industry?

Will it be tomorrow? 

Lost all hope and faith and just can't see it happening and am 99.9 % sure they'll vote for approval of these powerful and toxic drugs for use in children.



    
This message has been edited by SSRIAdmin on Jun 9, 2009 9:58 PM
This message has been edited by SSRIAdmin on Jun 9, 2009 9:57 PM
This message has been edited by SSRIAdmin on Jun 9, 2009 9:36 PM


 
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???

If drugmakers don't "RECOMMEND" those drugs for under 18s, why ask for approval?...

June 9 2009, 10:11 PM 

Well orchestrated Pfizer, Astra Zeneca and Lilly.

How much did you pay in 'unlimited educational grants' to NAMI and the rest?

How much did you pay to the APA and those groups?

How much do members of the FDA gain out of this?

Strangely, despite Kirsten Evraire,  saying:  "AstraZeneca....does not recommend Seroquel for patients under 18." The same is true of Pfizers Geodon.  However, physicians routinely exercise authority to prescribe medicines for off-label conditions beyond uses endorsed by the U.S. Food and Drug Administration",  those are 2 of the 3 drugs that the FDA are voting on re approval for children tomorrow, and who exactly have applied for their approval?  Drug companies that  DO NOT RECOMMEND those very same drugs for patients under 18? 

http://www.cjonline.com/news/state/2009-06-06/child%E2%80%99s_death_a_tragic_destiny

Childs death a tragic destiny

Photo 1 of 2 Destiny Hager's ashes will be buried Wednesday on what would have been her seventh birthday.   


MORE PHOTOS http://www.destiny-hager.memory-of.com/SlideShowPopUp.aspx', 'slideshow', 'width=650, \ height=605, \ location=no, \ menubar=no, \ resizable=no, \ scrollbars=no, \ status=no, \ toolbar=no'); return false;" href="javascript: void(0)">Open a slideshow to view additional photos of Destiny Hager. DOCUMENTS Consent Order in the Matter of Vernon L. Kliewer, M.D. First Amended Petition in the Matter of Vernon L. Kliewer, M.D.By Tim CarpenterCreated June 6, 2009 at 10:37pm
Updated June 7, 2009 at 12:10am

COUNCIL GROVE Destiny Hager could be delightfully charming and frightfully aggressive.

In her darkest moments, the 3-year-old smashed her head against walls, lashed out at family members and bit herself. She battled insomnia. Her mood swings were sharp. She tried to suffocate a dog.

Her condition demanded intervention. Counselors directed Destiny and her parents, Angela and Greg Hager, to Prairie View hospital in Newton. Vernon Kliewer, a child psychiatrist in whom the Hagers placed trust but now condemn, prescribed two powerful drugs to control Destiny.

The tiny girl with shoulder-length brown hair was tranquilized by the medical regimen. But the Hagers were uncomfortable with dosages obliterating Destinys personality. They scheduled a doctors visit to wean her from medication.

Destiny began complaining of a stomachache three days before the appointment. Her pain appeared to ease, but it later mushroomed. She was raced to a hospital. Her anguished cries echo in Angelas memory.

The sound of it stays with me every day, she said. If you can picture a wounded animal in a trap trying to free itself, thats what she sounded like.

Destiny died within hours.

After three years of searching, and with their daughters burial finally only days away, both parents have lingering questions about Destinys death. They dont feel all physicians who treated Destiny have been forthcoming. And they havent placed her demise in context of a complex national debate about medicating children with mental illness.

Code blue

Destiny was carried through the doors of Morris County Hospital at 11:20 p.m. April 3, 2006. An X-ray revealed her colon was blocked a known side effect of Seroquel and Geodon prescribed by Kliewer.

Angela said hospital physician Lora Siegle concluded the dosage of Seroquel authorized by Kliewer was inappropriately high for a 38-pound child. Siegles hospital notes say, I will stop the medications. The doctor considered sending Destiny to Childrens Mercy Hospital in Kansas City, Mo., but decided to care for the girl herself.

At 7:40 a.m., Destiny stopped breathing inside Room 11. A minister was called. Siegle managed to resuscitate Destiny. The girl was able to speak in a halting manner.

I love you, Destiny told her parents.

She required emergency surgery, but the modest hospital in this town of 2,300 wasnt staffed for the procedure.

A medical helicopter was called to transport Destiny to Childrens Mercy. Her pulse faded twice more, but doctors brought her back both times. Before LifeFlight departed, Angela said, a member of the air ambulance crew hugged the Hagers and offered advice.

She whispered in our ears 'Get an attorney. There were things done wrong here.

Legal surprise

A Baptist minister drove the Hagers toward Kansas City. Angela prayed for the best. Greg feared the worst.

You just know she isnt coming back, Greg said. Its the worst feeling anybody can have.

Destiny was pronounced dead at 10:34 a.m. on April 4 following a 45-minute flight.

The lives of Angela and Greg became a blur. Viewing their daughters lifeless body was crushing. An attempt to donate her organs failed. Later, strangers made them victims of malicious allegations. They also were beneficiaries of heartwarming empathy.

The Hagers hired the Wichita law firm of Hutton and Hutton to press a wrongful death lawsuit against Kliewer, Siegle and Morris County Hospital. Legal wrangling proceeded until December 2008 when Hutton and Hutton withdrew from all litigation involving Destiny. The law firm never fully explained to the Hagers satisfaction their reason for pulling out, the couple said.

The decision followed autopsy confirmation that Destiny died of fecal impaction and had antipsychotic drugs present in concentrations considered therapeutic in adults. The action came amid reports Geodon increased risk of potentially fatal heart-rhythm irregularities and people on Seroquel were more likely to suffer sudden cardiac death than patients taking older antipsychotics.

The Hagers attorneys walked away as state regulators completed a two-year investigation of Kliewer that found the doctor violated Kansas law while treating Destiny and five other children.

The Hagers say their own checkered past may have sabotaged this quest for justice and clarity.

About Destiny

Angela turned on the television in the familys one-story house outside Council Grove. She launched a DVD prepared for Destinys memorial service. Greg couldnt bear to again watch the slideshow chronicling the life of a child from June 10, 2002, to April 4, 2006.

Angela fought back tears, but narrated scenes set to music.

That was the day we brought her home from the hospital, she said. That was her last Christmas 2005. She loved to sing and dance and pose. She was such a ham.

As the final picture faded, she ticked off Destinys favorite activities: swimming, riding a toy horse, picking flowers, curling up to watch a movie.

Angela recalled giving her daughter nicknames. There was Moses, because Destiny tried to walk on water at age 1. Another was Mouse. It reflected Destinys habit of moving soundlessly across a room.

Destiny was born in Nebraska City, Neb. She moved frequently. She lived at times with her parents, a grandmother and friends. The Hagers were in Falls City, Neb., before coming to Council Grove.

We came down for a visit, stayed a while and fell in love with the area, Angela said.

Escalation

Angela became desperate to find help for Destiny. The staff at an Emporia clinic recommended a five-day stay at Prairie View. Greg didnt like the idea, but relented.

Greg, 45, and Angela, 30, were previously diagnosed with bipolar disorder. It is a manic-depressive illness affecting up to 3 percent of the population.

At Prairie View, Kliewer decided Destiny suffered the same ailment. She was put on Geodon and Seroquel. The dosage of Seroquel was ramped up to 600 milligrams per day by Kliewer.

He said a lot of doctors and a lot of people are going to say this is a really high dose, Greg said. But he says, 'I feel comfortable with it. Those were his exact words.

Kirsten Evraire, a spokeswoman for Seroquel manufacturer AstraZeneca, said the company does not recommend Seroquel for patients under 18. The same is true of Pfizers Geodon.

However, physicians routinely exercise authority to prescribe medicines for off-label conditions beyond uses endorsed by the U.S. Food and Drug Administration.

Russell Scheffer, professor of psychiatry and behavioral sciences at The University of Kansas School of Medicine in Wichita, said he has given Seroquel to children. He said 600 milligrams a day is reasonable. The medicine, he said, is an effective therapy for bipolarism. These are serious disorders, he said.

State inquiry

Kliewer, who has practiced medicine for 50 years, fell under the microscope of the Kansas Board of Healing Arts.

Board attorneys filed a petition in 2007 outlining the agencys investigation of Kliewers treatment of Destiny and five other children ranging in age from 2 to 5. The agency concluded Kliewer deviated from the standard of care, improperly prescribed medications and failed to properly document treatment.

In Destinys case, Kliewer inappropriately prescribed Seroquel and Geodon after failing to adequately assess and evaluate her condition. Kliewer ignored evidence of physical and sexual abuse among the other children.

Clearly, its severe enough theyve taken disciplinary action, said Jack Confer, executive director of the Board of Healing Arts. They thought it was a violation of state law. Kliewer was unwilling to comment.

The doctor negotiated a settlement in February with the Board of Healing Arts that didnt require him to admit wrongdoing. He voluntarily stopped treating patients under age 6.

The Board of Healing Arts placed his medical license on indefinite probation. He was ordered to pay $13,079 to cover the boards investigation expenses. Kliewer must have another physician monitor his treatment of bipolar patients.

Backlash

In the aftermath of Destinys death, Angela and Greg were placed on trial by innuendo.

Before they returned to Council Grove from the hospital in Kansas City, law enforcement officers declared their apartment a crime scene. Someone told police Destiny may have been mistreated.

We were cleared that evening, Greg said. Our daughter was well taken care of. That child was not abused.

Weird rumors persisted. Parents with children crossed to the other side of streets rather than walk past Angela. In a grocery store, someone accused the Hagers of murder.

The lawsuit put a spotlight on Angela and Greg. Attorneys for the county hospital and two doctors mined the Hagers background. Angela provided more ammunition in a deposition given last year to attorneys fighting the lawsuit.

Greg and Angela have arrest records hot checks, bad debts. Angela got a DUI.

We are recovering drug addicts, Angela said.

Neither was doing illegal drugs at the time of Destinys death, but Angela eventually fell back into her addiction, she said.

We are not perfect parents, she said. We are not perfect people.

Both say they are drug free and have sought grief counseling. Some people in Council Grove have softened their views of the couple.

Final resting place

The Hagers once sought millions of dollars to ease their pain. They now say they would be content with statements from Kliewer and Siegle admitting to mistakes.

Kliewers attorney, Brian Wright, of Great Bend, said that wouldnt happen.

Its a tragic case, Wright said.

The Hagers claim Siegle didnt provide adequate emergency care for Destiny.

Siegles attorney, Lisa McPherson, of Wichita, said the doctor stands by her work.

Destinys ashes will be buried Wednesday on what would have been her seventh birthday. The plot, which was donated, is in Kelso Cemetery north of Council Grove. The burial has been delayed so long because the couple couldnt afford it.

Standing amid a collection of family photographs in the living room, Greg said he could feel his daughters presence despite her absence. Maybe theres a rainbow at the end, Angela said. Even if all we did was bring awareness.

Tim Carpenter can be reached at (785) 295-1158 or timothy.carpenter@cjonline.com."


 
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FDA's panel of outside medical experts

FDA panel said today, Seroquel was 'acceptably safe' to treat schiz in adolescents...

June 10 2009, 8:08 PM 

http://online.wsj.com/article/BT-CO-20090610-712143.html

  • JUNE 10, 2009, 2:24 P.M. ET

FDA Panel Backs Seroquel To Treat Schizophrenia In Teens >AZN

 By Jennifer Corbett Dooren  Of  DOW JONES NEWSWIRES

WASHINGTON (Dow Jones)--A Food and Drug Administration panel said Wednesday Seroquel was "acceptably safe" and effective to treat schizophrenia in adolescents.

Seroquel, made by AstraZeneca PLC (AZN) is currently approved to treat schizophrenia and bipolar disorder in adults. The company is seeking FDA approval to market the drug to treat schizophrenia in adolescents ages 13 to 17 and bipolar disorder in children ages 10 to 17.

Seroquel is AstraZeneca's second-best selling drug with $4.45 billion in sales in 2008. Doctors already use the drug to treat children and adolescents, so it is unclear how receiving FDA approval to market the drug for use in younger patients would add to annual sales figures. The panel overwhelmingly voted that Seroquel was "acceptably safe" and effective.

 

Along with Seroquel, the FDA is considering Eli Lilly and Co.'s (LLY) Zyprexa to treat bipolar disorder and schizophrenia in adolescents and Pfizer Inc.'s (PFE) Geodon to treat bipolar disorder in children ages 10 to 17. Lilly is seeking so-called second-line status for Zxprexa, which means other drugs should be tried first.

An FDA panel of outside medical experts is discussing each drug and voting Wednesday whether it thinks the products are safe and effective for pediatric patients. The panel overwhelmingly voted that Seroquel was "acceptably safe" and effective.

The outcome of the votes will amount to a recommendation about whether the panel thinks the FDA should expand approval for the products. The FDA usually follows its panels' advice but is not required to.

"There are significant risks associated with these drugs," said Thomas Laughren, director of the FDA's psychiatric product division.

However, he noted there are just two other drugs approved for pediatric patients and said schizophrenia and bipolar disorder are "serious" diseases that need additional treatment options because patients respond differently to each drug. Risperdal, by a unit of Johnson & Johnson (JNJ), and Abilify, by Bristol-Myers Squibb Co. (BMY) and Otsuka Pharmaceutical Co., are approved to treat pediatric patients.

U.S. Food and Drug Administration staff said in memos released Friday that the three drugs were effective at treating the disorders in children and adolescents, but they carry "significant risks" that included sedation and weight gain.

The concern with weight gain seen with most antipsychotic drugs is whether it causes additional problems such as diabetes and cardiovascular disease.

The FDA asked each company to look at which side effects were more commonly seen in children compared to the adults who were studied in clinical trials.

AstraZeneca said side effects that occurred more frequently in children compared to adults on Seroquel included increases in blood pressure and increased appetite.

Schizophrenia afflicts about 1% of Americans. According to the National Institute of Mental Health, people with schizophrenia may hear voices other people don't hear or they may believe that others are reading their minds, controlling their thoughts or plotting to harm them. The disorder is also a cause of suicide and is typically diagnosed in a person's late teens or 20s.

Bipolar disorder, also known as manic-depressive illness, is believed to affect about 1% to 3% of the population, and is characterized by unusual shifts in mood, energy and activity levels. There is evidence that bipolar disorder in children is more severe than typically seen in adults. "

 


 
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Can guess the outcome of the 2 other drugs...

AND that Seroquel is safe and effective for 'bipolar' in kids aged 10 - 17.

June 10 2009, 8:16 PM 

http://www.google.com/hostednews/ap/article/ALeqM5jnDo60EPWjCw8_2HWlIf3NDDPOTgD98O01R01

  FDA panel OKs AstraZeneca psychiatric drug

17 minutes ago

ADELPHI, Md. (AP) Advisers to the Food and Drug Administration say a powerful psychiatric drug from AstraZeneca is safe and effective for children and adolescents.

The FDA's panel of experts voted overwhelmingly that the pill Seroquel is a useful treatment for schizophrenia and bipolar disorder in patients ages 10 to 17.

The group also is weighing expanded approval of drugs from Eli Lilly and Pfizer. All three drugs already are approved to treat adults with schizophrenia and bipolar disorder, also called manic depression.

The FDA is not required to follow the group's advice, though it usually does.

A positive FDA decision would allow the companies to expand marketing of drugs that already make up the top-selling class of prescriptions in the U.S."


 
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9 abstained re incomplete data from Pfizer

FDA Panel vote 8-1 that GEODON is safe and effective ages 13-17

June 10 2009, 8:59 PM 

So why didn't the 9 that abstained VOTE AGAINST approval until the data was provided at least?

http://www.guardian.co.uk/world/feedarticle/8551891

ADELPHI, Md. (AP) â Advisers to the Food and Drug Administration say a psychiatric drug from AstraZeneca is safe and effective for children and adolescents, despite side effects that can increase the risk of diabetes.

The FDA's panel of experts has voted overwhelmingly that Seroquel is a useful treatment for schizophrenia and bipolar disorder in patients ages 13 to 17.

The group also voted 8-1 that Pfizer's Geodon is safe for children and adolescents with bipolar disorder, though nine panelists abstained, complaining of incomplete data from the company.

The group also is weighing expanded approval of Eli Lilly's Zyprexa.

All three drugs already are approved for adults with schizophrenia and bipolar disorder.

The FDA is not required to follow the group's advice, though it usually does.

THIS IS A BREAKING NEWS UPDATE. Check back soon for further information. AP's earlier story is below


 
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admin

Looks like its the same with Zyprexa...news now says panel backs ALL 3

June 10 2009, 9:55 PM 

Clear copyright warning at the bottom, so please go to link:

FDA panel backs 3 psychiatric drugs for kids


 
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admin

Drug companies 3 - Children 0 n/t

June 10 2009, 9:56 PM 



    
This message has been edited by SSRIAdmin on Jun 10, 2009 9:57 PM


 
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Current Topic - FDA: Meeting 9th & 10th June re 'safety' of antipsychotics for children
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