Posts Tagged ‘SSRIs’

SSRIs Render Unfriendly Skies—FOIA documents reveal what FAA failed to consider in allowing pilots on antidepressants to fly

Wednesday, July 14th, 2010

Scoop Independent News
By Evelyn Pringle
July 14, 2010

The SSRI antidepressant makers are desperate to find new customers, so they recently have been focusing on capturing groups for which the drugs were usually considered off limits. The latest marketing coup managed to open up sales to roughly 614,000 American pilots.

Under a new policy announced on April 5, 2010, pilots diagnosed with depression can seek permission from the Federal Aviation Administration to take one of four SSRIs, including Eli Lilly’s Prozac, Pfizer’s Zoloft, and Forest Laboratories’ Celexa and Lexapro.

“The FAA should reverse its ruling before it’s too late and hundreds of lives are lost when a pilot becomes impulsive, suicidal or violent–or just loses his sharpness–under the influence of antidepressant medication,” said SSRI expert, Dr Peter Breggin, in an April 19, 2010 Huffington Post commentary.

The Citizens Commission on Human Rights is also calling on the FAA to rethink allowing pilots to take SSRI in light of a new report issued last month by the National Transportation Safety Board, on a February 1, 2008 plane crash in North Carolina, by a crazy acting pilot on Zoloft, that killed all six persons on board

The report said the pilot failed to maintain control of the plane during instrument flying conditions and “deliberately descended below the minimum descent altitude.” The plane stalled and crashed while circling after an aborted landing.

“Review of the cockpit voice recorder (CVR) audio revealed that the pilot had displayed some non-professional behavior before initiating the approach,” the NTSB reported.

The CVR recorded the pilot singing: “Save my life I’m going down for the last time,” before beginning a commentary in which he told passengers: “If anybody back there believes in the good Lord, I believe now would be a good time to hit your knees.”

A review of medical records documented that “from December 4, 2006 through December 31, 2007, the pilot had filled 6 prescriptions for 30 tablets of 50 mg sertraline (Zoloft),” the report said.

The records indicated that he had been treated previously with two other antidepressant medications for “anxiety and depression” and a history of “impatience” and “compulsiveness,” the NTSB noted.

An investigation of another plane crash, resulting in two fatalities in Kingsport, Tennessee, in August 2003, found Zoloft in the blood and liver of a private flight instructor, according to an accident report by the NTSB.

In the policy statement published in the Federal Register, the FAA seems to justify the use of these drugs via the fully debunked “chemical imbalance in the brain” theory when writing: “All these medications are SSRIs, antidepressants that help restore the balance of serotonin, a naturally occurring chemical substance found in the brain.”

“Increasingly accepted and prevalently used, these four antidepressants may be used safely in appropriate cases with proper oversight and have fewer side effects than previous generations of antidepressants,” the FAA wrote, with no citation to any scientific paper to back up this assertion.

In fact, the current labels on SSRIs warn that “anxiety, agitation, panic attacks, insomnia, irritability, hostility, aggressiveness, impulsivity, akathisia (psychomotor restlessness), hypomania, and mania, have been reported in adult and pediatric patients treated for major depressive disorder as well as for other indications, both psychiatric and nonpsychiatric.”

“Even when not severe, these reactions impair judgment and increase the likelihood of accidents and violence,” according to Dr Breggin.

CCHR has set up a great website with a one-of-a-kind search engine that allows the public and officials to access the database on side effects reported to the FDA on SSRIs, and every other psychiatric drug. The site also has a search engine to access all the International warnings and studies on psychiatric drugs which have been summarized so they are easy to understand, even to a lay person.

Input Only From the Choir

On April 6, 2010, Bob Fiddaman, author of the long-running popular website and blog, “Seroxat Sufferers,” sent a request to the FAA, under the Freedom of Information Act, seeking information on the change in policy.

In the Federal Register, the FAA claims it came to its decision after “careful consideration.” However, in the 58 pages of documents sent to Fiddaman on June 9, 2010 (and kindly shared with this author), there is no mention of consultations with any of the prominent SSRI experts who may have offered a contrary view. Like Peter Breggin for instance.

The FAA’s response to Fiddaman shows the agency has been discussing the policy change since at least 2008. In response to a request for “minutes of meetings where the change in the policy was on the agenda,” as well as a list of “members present and a declaration of interests of each of the members,” the FAA sent a copy of a July 18, 2008, Memorandum, with a summary from one consultants meeting. Three outside experts attended but there were no declarations of interests, or lack thereof, by anyone at the meeting.

The summary noted that the consultants “unanimously agreed that the concept of allowing certain airmen taking antidepressant medication was reasonable and safe.” But the “unanimous consensus” was that only Prozac and Zoloft “were appropriate medications due to the longevity of their use and overall safety.”

“They also felt that only these two should be considered initially, and no other medications considered at this time,” the summary reported.

In responding to the question of whether the new policy would apply to Air Traffic Controllers, the FAA said the “new policy does not presently apply to Air Traffic Control Specialist (ATCS) because the administrative details of the monitoring and follow-up of these employees are yet to be determined. The plan is that ATCSs will eventually be included in a program of this type.”

In response to a request for any information “given to FAA from outside parties that relate to the FAA’S recent change in policy regarding pilots on antidepressant medication,” the FAA sent copies of documents received from the Aerospace Medical Association, the Airline Pilots Association Aeromedical Office, the International Airline Pilots Association, and the United States Army.

“In developing the new policy, the FAA also utilized a variety of medical research literature available in the public domain,” the response said. “We used internet sites such as, but not limited to: The National Library of Medicine PubMed site and the FDA Medwatch.”

The documents Fiddaman received show consideration of a 2003 study of aviation accidents that found SSRIs in 61 pilot fatalities between 1990-2001, in which the psychological condition and/or the drug use was determined to be the cause, or a factor in 16 of the accidents, or 31%.

However, there was no mention of a later November 2006 study titled, “Pilot Medical History and Medications Found in Post Mortem Specimens for Aviation Accidents,” led by Dennis Canfield, from the FAA’s Civil Aerospace Medical Institute, in the “Aviation, Space, and Environmental Medicine” journal.

For this study, toxicological evaluations were performed on 4,143 pilots involved in fatal aviation accidents during the period between January 1, 1993, through December 31, 2003, to identify all pilots found positive for medications used to treat cardiovascular, psychological, or neurological conditions.

The evaluations found one-hundred dead pilots with SSRIs in their systems including forty with Prozac, twenty-six with Zoloft, twenty-one with Paxil, and thirteen with Celexa.

Less than a month after the new policy was announced, in “Aviation International News,” on May 1, 2010, Matt Thurber reported that in a review of 127 accidents in the NTSB database since 1991, containing the word “antidepressant,” only three were nonfatal.

“In 124 of those accidents, 211 people were killed,” Thurber said. “In accident after accident, antidepressants … were found in the tissues of dead pilots, and the pilots had falsified their medical certificate applications to show that they had never been treated for psychiatric problems.”

Read the rest of this article here:  http://www.scoop.co.nz/stories/HL1007/S00116.htm

Read FOIA documents here: http://fiddaman.blogspot.com/p/faa-respond-to-freedom-of-information.html

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Jury recommends major reforms in drug prescribing after investigation of 18-year-old’s suicide under the influence of Paxil

Wednesday, June 30th, 2010

Pharmalot
By Ed Silverman
June 30, 2010

There have been numerous claims that a medication caused a suicide, but few lead to sweeping changes. In Canada, however, the suicide of 18-year-old Sarah Carlin, who had taken the Paxil antidepressant, is a clear exception. Following a coroner’s inquest, Canada’s provincial and federal governments were told to ensure patients are better informed about drug risks, tighten regulations on drugmakers and establish an independent agency to regulate medications.

“If these things had been in place at the time Sara was prescribed Paxil, she would be alive today,” her father, Neil Carlin, said outside court. “We consider this a great victory…We are truly confident that if these are acted upon there will be young lives saved down the road.”

For more than a year before her death, Sara had been taking Paxil, an anti-depressant, which Health Canada warns can increase the risk of suicidal events in children and adolescents under 18. The teenager hanged herself in her parents’ basement in May 2007. The inquest made numerous recommendations, which you can see if you keep reading…

Of the various recommendations, the one that is garnering the most discussion appears to be the creation of a Drug Safety Board to investigate the side effects and issue warnings to the public, doctors and hospitals. The inquest specifically recommended the new board not receive any funding from drugmakers. Drugmakers must also report all adverse events to Health Canada within 30 days.

A Glaxo spokeswoman writes to says the drugmaker “is supportive of appropriate recommendations designed to prevent similar tragedies from occurring in the future, and will give the recommendations addressed to the broader pharmaceutical industry our full attention and consideration. Sara Carlin’s death was a tragedy and we continue to express our deepest sympathies to her family.”

1. The Ministry of Health and Long-Term Care (MOHLTC) should develop a Drug Information System. This system would promote:
• Patient safety in the prescribing and dispensing of drugs.
• Collection and compilation of data in a single repository for all drugs dispensed for all Ontarians.
• Research into drug and patient safety.

2. The Drug Information System should track and monitor all drugs dispensed in Ontario regardless of who is paying for the prescription.

3. The Drug Information System should collect, compile and release data upon request to scientists such as those studying population-based health outcomes at the Institute for Clinical Evaluative Sciences.

4. The Ministry of Health and Long-Term Care should commit to developing a province-wide suicide prevention strategy as has occurred in other provinces such as Alberta.

5. The objectives of the province-wide suicide prevention strategy should include:
• Enhanced mental health and well being for Ontarians.
• The education of the public to de-stigmatize mental health disorders, including depression and substance abuse disorders.
• Improving intervention and support for Ontarians affected by depression and substance abuse.
• Improving intervention and treatment for those at risk of suicide.
• Increased efforts to reduce access to lethal means of suicide.
• Increased research activities in Ontario on suicide, suicidal behaviour and suicide prevention.
• Improved suicide and suicidal behaviour-related surveillance systems.
• Inform and educate the media into strategies when reporting deaths due to suicide to prevent ‘copy cat’ suicides from occurring.

6. Strategies in the province-wide suicide prevention strategy should be humane, effective and evidence based, respectful of community and culture-based knowledge, inclusive of research, surveillance, evaluation and reporting and reflective of evolving knowledge and practices.

7. The ministry of Health and Long-Term Care of Ontario and Government of Ontario should commit to supporting the development of a national suicide prevention strategy for all Canadians.

Read entire article:  http://www.pharmalot.com/2010/06/sara-carlin-paxil-and-drug-safety-in-canada/

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The Globe and Mail — “Is Depression a Disease? Big Pharma says yes, but others aren’t so sure”

Friday, June 18th, 2010

Big Pharma says yes, but others aren’t so sure

The Globe and Mail
By Leah McLaren
June 18, 2010

“It’s all in your head” isn’t something a chronically depressed person likes to hear. In the age of Prozac, when adjusting your serotonin level is as normal as checking the oil in your car, it seems unhelpful to suggest that someone might think their way into – or out of – a disease of the mind.

And yet depression is all in our heads. Where else would it be? The real question, still hotly debated in the scientific community, is whether its cause is chemical and ultimately curable (good news for Big Pharma) or something far more complex (good news for poets and pot-smoking students of existential philosophy).

There is no doubt that depression exists. Inexplicable sadness – or “melancholia,” as it was historically known – has been with us since Hippocrates conceived his famous oath. But a groundbreaking new study has found that not only is depression affected by the way we think about it, so too is its cure.

Last week Irving Kirsch, a professor at the University of Hull in the U.K., presented a study that found Prozac and its ilk are no more effective than placebos in treating depression. In his view, there is no substantial link between serotonin – the brain chemical that antidepressants are supposed to regulate – and chronic depression.

It’s a controversial study – one that many members of the psychiatric community reject out of hand – but it also raises a nagging question about depression: How did it come to be recognized as a disease in the first place?

Like Hirsch, psychologist and writer Gary Greenberg is part of a growing number of psychiatric professionals who have begun to publicly question the underpinnings of popular thinking on depression.

Read entire article:  http://www.theglobeandmail.com/life/style/is-depression-a-disease/article1609422/

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Toronto Sun—“The girl with every reason to live” Parents blame daughter’s suicide on antidepressant Paxil

Saturday, June 12th, 2010

Toronto Sun
By Michelle Mandel
June 12, 2010

Sara Carlin had everything to live for: She was smart, athletic, beautiful and pursuing her dream of becoming a doctor.

But on May 6, 2007, that bright future ended abruptly with a piece of electrical wire.

The promising 18-year-old had hung herself in her family’s Oakville basement and her grieving parents blame her suicide on the Paxil antidepressant she’d been prescribed more than a year before.

In emotional testimony that left many fighting back tears, Sara’s mother Rhonda told a coroner’s inquest that her daughter earned 90’s in school, played baseball and women’s hockey, held a part-time job at an optometrist’s office and tutored other kids in math.

“She was a pretty exceptional girl, she was absolutely loving and she was beautiful,” her mom proudly recalled Wednesday before the presiding coroner, Dr. Bert Lauwers. “She really was an exceptional daughter.”

But in the early part of 2006, Sara began to change. During the family’s March break vacation to Palm Springs, she wouldn’t get out of bed most days and got drunk at dinner. “It was so unlike her,” her mom said.

It was only later that she learned Sara had complained of anxiety and depression to her family doctor and had recently been prescribed Paxil, one of the antidepressants known as selective serotonin reuptake inhibitors (SSRIs).

“I said, ‘Why on earth, Sara would you be on antidepressants?’ I was astounded,” she recalled for the five-member jury. “Why, why would he be giving these to her? This was a wonderful, happy girl.”

While Sara lost her much older brother to a drug overdose in 2000, her mother believed her daughter had coped well with his death and never wanted the counselling she’d been offered.

So this need for antidepressants, she said, came out of the blue.

“She was very troubled, much more troubled than any of us knew,” her mother acknowledged.

While her parents repeatedly voiced their reservations about Paxil, Sara brushed them off, saying her doctor told her it would make her feel better. “I didn’t even know the horrific side effects of Paxil at that time,” her mom said. “I certainly didn’t know what I know now.”

Health Canada issued warnings in 2003 and 2004 that prescribing antidepressants to teens could lead to behavioural or emotional changes that might put them at increased risk of suicidal behaviour.

Read entire article:  http://www.torontosun.com/news/columnists/michele_mandel/2010/06/10/14340951.html

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Antidepressants Linked to Blindness in Older Adults

Tuesday, June 8th, 2010

Main Street
By Althea Chang
June 8, 2010

Antidepressant use could be linked to blindness in older adults, a recent study suggests.

Drugs that treat depression known as selective serotonin reuptake inhibitors, or SSRIs, caused an increased risk of developing cataracts in patients aged 65 or older, according to a study published in the journal Ophthalmology in June.

Researchers said cataracts may be more likely to develop in patients using this specific type of depression medication because serotonin receptors are found in the lens of the eye, according to MedPage Today.

Cataracts occur when the ocular lens gets cloudy and causes vision loss and even blindness. According to the World Health Organization, cataracts are responsible for 48% of age-related blindness cases worldwide.

While the elderly are generally more prone to developing cataracts than the population as a whole, researchers said they adjusted their study results to consider blood pressure, use of other medications and gender among the 200,000 people involved.

Read entire article:  http://www.mainstreet.com/article/family/family-health/antidepressants-linked-blindness

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Lawyers & Settlements—Mom Alert: Would you want a 68% Higher Risk of Miscarriage? (Antidepressants & Pregnancy study)

Thursday, June 3rd, 2010

Lawyers & Settlements
By LucyC
June 2, 2010

A new study out yesterday—June 1, 2010—has revealed a higher rate of miscarriages in women who were taking antidepressants during pregnancy. How much higher? Sixty-eight percent—yes —that’s 68%—higher. Frankly, that is nothing short of shocking.

Published in the Canadian Medical Association Journal, the study was done in Canada through the University of Montreal. FYI—This was no small study either—the investigators used data from 5,124 women who are part of a large, population-based study of pregnant women who had clinically verified miscarriages, and a large sample of women from the same registry who did not have a miscarriage. Among the women who miscarried, 284 or 5.5 percent, had taken antidepressants during their pregnancy.

In fact the findings are so robust that the physicians who did the study are suggesting that this is a class effect—in other words the effect could be attributed to all selective serotonin reuptake inhibitors—or SSRIs. Here’s what’s being reported in the press:

“These results, which suggest an overall class effect of selective serotonin reuptake inhibitors, are highly robust given the large number of users studied,” the study’s senior author, Dr. Anick Berard, said in a statement. (UPI.com)

The antidepressants that showed a particular association with miscarriage in the study were paroxetine (trade names: Seroxat and Paxil) and venlafaxine (trade names: Effexor, Efexor, Alventa, Argofan, Trevilor). The investigators also found that the risk of miscarriage doubled with a combination of different antidepressants.

Just for the record, the antidepressants “investigated” in the University of Montreal study are serotonin reuptake inhibitors (citalopram, fluoxetine, fluvoxa-mine, paroxetine and sertraline); tricyclic antidepressants (ami-triptyline, clomipramine, desipramine, doxepin, imipramine, nortriptyline, trimipramine), serotonin– norepinephrine reuptake inhibitors (venlafaxine) and “other antidepressants” (serotonin modulators, monoamine oxidase inhibitors, tetracyclic piperazino-azepines, and dopamine and norepinephrine reuptake inhibitors).

This study is just the latest to show an association between, well, for lack of a better term let’s say “serious adverse events” and SSRIs and SNRIs in particular.

Read entire article:  http://www.lawyersandsettlements.com/blog/mom-alert-would-you-want-a-68-higher-risk-of-miscarriage-03819.html

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New Study—Taking Antidepressants While Pregnant More Than Doubles Risk of Miscarriage

Tuesday, June 1st, 2010

Los Angeles Times
By Thomas H. Maugh II
May 31, 2010

Taking antidepressants during pregnancy increases the risk of spontaneous abortions by about two-thirds, Canadian researchers reported Monday. The increased risk was greatest with the family of drugs known as selective serotonin reuptake inhibitors (SSRIs), especially paroxetine and venlafaxine, and when more than one family of drugs were used.

Depression in women is most common during the child-bearing years, and estimates suggest that as many as 15% of pregnant women suffer from it. Because of fears about the effects of drugs, particularly psychiatric drugs, during pregnancy, only about 3.7% of women use them during the first trimester. Most studies looking at the use of antidepressants during pregnancy have focused on their effects on the fetus. Small studies of their effects on abortion have produced inconsistent results. Expecting mothers cannot routinely stop using the drugs, however, because that also presents risks to both the mother and the fetus.

Producing a controlled clinical trial examining the effects of the drugs is virtually impossible because few women would be willing to participate, experts said. The only way to get at the data is to examine it retrospectively.

In the new study, Dr. Anick Berard, director of the University of Montreal’s Research Unit on Medications and Pregnancy at University Hospital Center Sainte-Justine used information from the Quebec Pregnancy Registry to identify 5,124 women who had a spontaneous abortions between 1998 and 2003 — before warnings about the risks of the drugs became more common — and compared them with about 10 times that many carefully matched women who did not have abortions. A separate database provided information about prescriptions the women had filled.

Read entire article:  http://latimesblogs.latimes.com/booster_shots/2010/05/antidepressants-during-pregnancy-increase-risk-of-sponaneous-abortion-study-finds.html

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Wrongful Death Suit Claims Anti-depressant Led to Elderly Couple’s Murder-Suicide

Friday, May 28th, 2010

The West Virginia Record
By Lawrence Smith
May 28, 2010

RIPLEY — The murder-suicide of a Jackson County couple is at the center of a wrongful death, and product liability suit against New York pharmaceutical company.

Forest Laboratories and Forest Pharmaceuticals are named as co-defendants in a lawsuit filed in Jackson Circuit Court on April 30 by Robin J. Hall. In her six-count complaint, Hall, 49, a resident of Staats Mill, alleges Forest failed to alert both her father, and his physician of potentially dangerous side-effects of medication he was taking which resulted in him taking the life of his wife, then his own.

Located in New York, N.Y., Forest Laboratories is the parent company of Forest Pharmaceuticals based in St. Louis, Mo. Forest Pharmaceuticals handles the manufacture, sell and distribution of all Forest products in the United States.

In her suit, Hall says her father, Robert Raines, was prescribed Celexa by his doctor on April 24, 2008. Later that day, Raines purchased Celexa in 20 mg tablets.

Celexa is the brand name for Citalopram, a psychoactive drug in the class of selective serotonin reuptake inhibitors. It is used mostly for treatment of depression by altering a person’s serotonin levels.

Forest, Hall alleges, was aware Celexa caused an increased risk of suicidal behavior in people over 65, yet failed to conduct any further testing or investigation. Also, she alleges in its promotional materials, Forest failed to warn not only patients, but also physicians and pharmacists of that risk.

As early as Oct. 15, 2004, Forest was aware of the causality between SSRI drugs like Celexa and suicidal behavior in children. It was then, the U.S. Food and Drug Administration ordered Forest to put a “black box warning” on Celexa for anyone under the age of 24 about the potential risk of suicidal behavior.

Read entire:  http://www.wvrecord.com/news/227152-anti-depressant-led-to-elderly-couples-murder-suicide-jackson-suit-claims

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The Daily Mail: UK Drug Regulatory Agency warns pregnant women of antidepressants danger to their unborn child

Monday, May 17th, 2010

The Daily Mail
By Jo MacFarlane
May 16, 2010

Women who use antidepressants while pregnant are being warned by health chiefs about the risks to their unborn child.

The Government’s medicines watchdog advised doctors there is an increased risk that babies will be born with a rare lung condition if expectant mothers take drugs such as Prozac and Seroxat.

The Medicines and Healthcare products Regulatory Agency (MHRA) is recommending they are monitored more carefully because of the risk of developing persistent pulmonary hypertension after birth.

The condition normally affects up to two in 1,000 births – but the latest research suggests the risk is more than doubled in women taking antidepressants, affecting five in 1,000 births. The life-threatening condition means infants do not adapt to breathing outside of the womb.

The risk is greater if the medicines known as SSRIs – a new generation of depression wonder drugs – are taken later in the pregnancy.

The warning comes five years after studies first showed there may be a link between the drugs and birth defects. The MHRA advised doctors not to prescribe the drugs to pregnant women unless necessary.

However, it was revealed last year that GPs were still prescribing them to women considering becoming pregnant.

Read entire article:  http://www.dailymail.co.uk/health/article-1278675/Pregnant-women-warned-antidepressants-danger-unborn-child.html?ito=feeds-newsxml

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Child/Teen Suicide Rate 5 Times Higher for Kids on Antidepressants; Researchers Say findings support FDA Black Box Warnings

Monday, April 12th, 2010

WebMD
By Jennifer Warner
April 12, 2010

The heightened risk of teen suicide doesn’t vary among users of different antidepressants, a new study finds.

Researchers say the finding supports the FDA’s current “black box” warning on all antidepressants detailing the increased risk of suicide attempts and suicides in children and teens who start to take the drugs. A “black box” warning is the FDA’s most severe warning label.

Previous studies have shown that children and teenagers who begin to use SSRI (selective serotonin reuptake inhibitor) antidepressants may have an increase in suicidal thoughts and behaviors, but researchers say this is the first study to compare the child and teen suicide risk among different individual SSRI antidepressants.

The study followed 20,906 children in British Columbia between the ages of 10 and 18 who had been diagnosed with depression and prescribed an antidepressant over a nine-year period.

During the first year of antidepressant use, there were 266 attempted suicides and three suicides.

Researchers found no significant difference in child and teen suicide risk among the five SSRI antidepressants studied (fluoxetine, fluvoxamine, citalopram, paroxetine, and sertraline). Tricyclic antidepressants showed risks similar to the SSRIs.

Overall, the child and teen suicide rate after initiation of antidepressant use among participants in the study was five times higher than the rate reported among all teens aged 13 to 17 in British Columbia, which researchers say reflects the higher suicide risks among the depressed.

“Our analysis supports the decision of the Food and Drug Administration to include all antidepressants in the black box warning regarding increased suicidality risk for children and adolescents initiating use of antidepressants,” write researcher Sebastian Schneeweiss, MD, ScD of Harvard Medical School and colleagues in Pediatrics.

Read entire article:  http://www.webmd.com/depression/news/20100412/teen-suicide-risk-similar-among-antidepressants

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