Antidepressants

Antidepressants Barely Work, if at all:

Antidepressants and other mood-altering drugs dangerous with very little benefit, expert argues
http://news.nationalpost.com/health/antidepressants-and-other-mood-altering-drugs-dangerous-with-very-little-benefit-expert-argues

Sharon Kirkey | May 13, 2015 1:09 PM ET
Antidepressants and other psychiatric drugs provide so little benefit that doctors could stop writing 98 per cent of all prescriptions without causing harm, a Danish expert argues this week in a leading medical journal piece that has renewed the debate around fast-growing prescriptions of mood-altering drugs.

Dr. Peter Gotzsche argues in the British Medical Journal that flawed and biased industry-funded drug trials have overplayed the benefits and understated the deaths from antidepressants, tranquilizers and antipsychotics.

Canadian leaders in psychiatry call the claims misleading, misguided and dangerous. But Gotzsche calculates that psychiatric drugs contribute to the deaths “of more than half a million people” aged 65 and older in the Western world alone, including deaths due to suicide.

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Antidepressants and the Placebo Effect
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4172306/
Irving Kirsch Z Psychol. 2014; 222(3): 128–134.
Abstract
Antidepressants are supposed to work by fixing a chemical imbalance, specifically, a lack of serotonin in the brain. Indeed, their supposed effectiveness is the primary evidence for the chemical imbalance theory. But analyses of the published data and the unpublished data that were hidden by drug companies reveals that most (if not all) of the benefits are due to the placebo effect. Some antidepressants increase serotonin levels, some decrease it, and some have no effect at all on serotonin. Nevertheless, they all show the same therapeutic benefit. Even the small statistical difference between antidepressants and placebos may be an enhanced placebo effect, due to the fact that most patients and doctors in clinical trials successfully break blind. The serotonin theory is as close as any theory in the history of science to having been proved wrong. Instead of curing depression, popular antidepressants may induce a biological vulnerability making people more likely to become depressed in the future.

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Study: Most antidepressants don’t work for young patients
http://bigstory.ap.org/article/198b33aad59e4a6c8a3c4aeae27940c0/study-most-antidepressants-dont-work-young-patients
By MARIA CHENG
Jun. 8, 2016
LONDON (AP) — Scientists say most antidepressants don’t work for children or teenagers with major depression, some may be unsafe, and the quality of evidence about these drugs is so bad the researchers cannot be sure if any are truly effective or safe.
In the biggest analysis yet conducted of previously published studies, researchers studied 14 antidepressants and found only one drug that seemed to be useful.

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Antidepressants versus placebo in major depression: an overview
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4592645/
World Psychiatry. 2015 Oct; 14(3): 294–300.

Arif Khan1,2 and Walter A Brown3

ABSTRACT: Although the early antidepressant trials which included severely ill and hospitalized patients showed substantial drug-placebo differences, these robust differences have not held up in the trials of the past couple of decades, whether sponsored by pharmaceutical companies or non-profit agencies… As of now, antidepressant clinical trials have an effect size of 0.30… is less than impressive.

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St. John’s wort for treating depression.
http://www.cochrane.org/CD000448/DEPRESSN_st.-johns-wort-for-treating-depression.
8 October 2008
by Linde K, Berner MM, Kriston L

Depression is characterised by depressed mood and/or loss of interest or pleasure in nearly all activities and a variety of other symptoms for periods longer than two weeks. Extracts of St. John’s wort (botanical name Hypericum perforatum L.) are prescribed widely for the treatment of depression.
We have reviewed 29 studies in 5489 patients with depression that compared treatment with extracts of St. John’s wort for 4 to 12 weeks with placebo treatment or standard antidepressants.
… Overall, the St. John’s wort extracts tested in the trials were superior to placebo, similarly effective as standard antidepressants, and had fewer side effects than standard antidepressants.

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Initial severity and antidepressant benefits: a meta-analysis of data submitted to the Food and Drug Administration.
http://www.ncbi.nlm.nih.gov/pubmed/18303940
PLoS Med. 2008 Feb;5(2):e45.
Kirsch I1, Deacon BJ, Huedo-Medina TB, Scoboria A, Moore TJ, Johnson BT.
Meta-analyses of antidepressant medications have reported only modest benefits over placebo treatment, and when unpublished trial data are included, the benefit falls below accepted criteria for clinical significance. Yet, the efficacy of the antidepressants may also depend on the severity of initial depression scores. The purpose of this analysis is to establish the relation of baseline severity and antidepressant efficacy using a relevant dataset of published and unpublished clinical trials.
METHODS AND FINDINGS:
We obtained data on all clinical trials submitted to the US Food and Drug Administration (FDA) for the licensing of the four new-generation antidepressants for which full datasets were available. We then used meta-analytic techniques to assess linear and quadratic effects of initial severity on improvement scores for drug and placebo groups and on drug-placebo difference scores. Drug-placebo differences increased as a function of initial severity, rising from virtually no difference at moderate levels of initial depression to a relatively small difference for patients with very severe depression, reaching conventional criteria for clinical significance only for patients at the upper end of the very severely depressed category. Meta-regression analyses indicated that the relation of baseline severity and improvement was curvilinear in drug groups and showed a strong, negative linear component in placebo groups.
CONCLUSIONS:
Drug-placebo differences in antidepressant efficacy increase as a function of baseline severity, but are relatively small even for severely depressed patients. The relationship between initial severity and antidepressant efficacy is attributable to decreased responsiveness to placebo among very severely depressed patients, rather than to increased responsiveness to medication.
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More Irving Kirsch studies:

2002 alphachoices.com/repository/assets/pdf/EmperorsNewDrugs.pdf
2005 https://www.ncbi.nlm.nih.gov/pmc/articles/PMC558707/  Efficacy of antidepressants in adults.
2008 https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2582668/ Challenging Received Wisdom: Antidepressants and the Placebo Effect
2009 https://www.ncbi.nlm.nih.gov/pubmed/20170046 Antidepressants and the placebo response.
1010 https://www.ncbi.nlm.nih.gov/pubmed/21856612 Review: benefits of antidepressants over placebo limited except in very severe depression.
2011 https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3714297/ The use of placebos in clinical trials and clinical practice. (In psychiatry)

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Do Antidepressant Drugs Really Work?
http://www.care2.com/greenliving/do-antidepressant-drugs-really-work.html
By: Dr. Michael GregerApril 8, 2016
We’ve learned that exercise compares favorably to antidepressant medications as a first-line treatment for mild to moderate depression. But how much is that really saying? How effective are antidepressant drugs in the first place?

A recent meta-analysis has sparked huge scientific and public controversy by stating that the placebo effect can explain the apparent clinical effectiveness of antidepressants. But aren’t there clinical trials providing compelling evidence for antidepressant effectiveness, in fact thousands of them? If a meta-analysis just compiles together all the best published research, how could it say they don’t work much better than sugar pills? The key word is “published.”

What if a drug company decided only to publish studies that showed a positive effect, but quietly shelved and concealed any studies showing the drug didn’t work? If you didn’t know any better, you’d look at the published medical literature and think “Wow, this drug is great.” And what if all the drug companies did it? To find out if this was the case, researchers applied to the FDA under the Freedom of Information Act to get access to the published and unpublished studies submitted by pharmaceutical companies, and what they found was shocking.

According to the published literature, the results of nearly all the trials of antidepressants were positive, meaning they worked. In contrast, FDA analysis of the trial data showed only roughly half of the trials had positive results. In other words, about half the studies showed the drugs didn’t work…

 

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Sexual Dysfunction


Antidepressant-Induced Sexual Side Effects
https://womensmentalhealth.org/posts/antidepressant-induced-sexual-side-effects-2/?doing_wp_cron=1474902925.8594670295715332031250

By MGH Center for Women’s Mental Health
October 1, 2007

A recent article published in Psychiatric Times reviews options for the management of antidepressant-induced sexual dysfunction. According to this review, sexual side effects may occur in 40% to 70% of patients treated with serotonin reuptake inhibitors (SRIs) and is a common reason for poor compliance with treatment and eventual discontinuation. When sexual side effects occur, they tend to emerge early, are persistent, and rarely resolve spontaneously.

While men most commonly experience premature ejaculation (31%), performance anxiety (18%), and low sexual desire (15%), the most common complaints in women are low sexual desire (32%), inability to achieve orgasm (26%), and sex not being pleasurable (23%).

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Violence, Suicide & Psychosis:

Over 5,000 media accounts of people becoming violent, suicidal or psychotic while on or withdrawing from antidepressants – click www.SSRIstories.com

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Antidepressants Linked to Violence: Rape, Robbery and Homicide
http://www.peoplespharmacy.com/2015/09/28/antidepressants-linked-to-violence-rape-robbery-and-homicide/

A study from Sweden has found an association between antidepressants and convictions for assault, robbery, arson, sexual offense or homicide.

The People’s Pharmacy September 28, 2015

  1. I am 30 years old and have been taking fluoxetine. I was prescribed this last year because I attempted to take my own life.

I have noticed that my behavior, though no longer suicidal, is increasingly irrational. I get explosively angry at the smallest of things and struggle daily to control my temper towards my husband.

Until now I would have said that the drug was working for me, but recently I have begun to question whether it is in fact putting my husband at risk. My explosive reactions are right on the edge of violence. Is it possible that the drug is having a negative effect on me?

  1. When antidepressants like fluoxetine (Prozac), paroxetine (Paxil) or sertraline (Zoloft) were linked to suicidal thoughts in some patients, most health professionals were skeptical. After all, these drugs are prescribed to lift depression and prevent suicide, as fluoxetine did for you. The FDA now requires such medications to carry a black box warning about suicidal thoughts or behaviors, however.

A new study from Sweden (PLOS Medicine, Sept 15, 2015)  suggests that people between 15 and 24 are more likely to commit violent crimes if they are taking SSRI-type antidepressants or venlafaxine (Effexor). These individuals were convicted of assault, robbery, arson, sexual offense or homicide.

Can Antidepressants Trigger Homicide As Well As Suicide?

Americans have a hard time…

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Antidepressants can increase risk of bipolar and mania by up to 35%
http://www.ibtimes.co.uk/certain-antidepressants-can-increase-risk-bipolar-mania-by-35-1533501

By Sean Martin
December 15, 2015

Some types of antidepressants can increase the risk of mania and bipolar disorder, a new study has revealed. Research led by Dr Rashmi Patel of the Department of Psychosis Studies at King’s College London, found that serotonin reuptake inhibitors, or SSRIs, and venlafaxine have the strongest ties to the subsequent development of the two mental illnesses.

The team analysed data from medical records of 21,000 patients diagnosed with depression between 2006 and 2013. Of these people, 1.1% had been diagnosed with mania and/or bipolar.

The team states that further research revealed that those who were on SSRIs and venlafaxine were at a 34-35% heightened risk of developing the two other mental illnesses…

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A STUDY IS PUBLISHED IN THE AMERICAN JOURNAL OF PSYCHIATRY IN 1990 SHOWING THAT PROZAC (FLUOXETINE) COULD CAUSE “INTENSE, VIOLENT SUICIDAL PREOCCUPATION”
Martin H. Teicher, M.D. PhD. et al., ‘Emergence of Intense Suicidal Preoccupation During Fluoxetine Treatment,” The American Journal of Psychiatry, 1990; 147: 207-210)

“Six depressed patients free of recent serious suicidal ideation developed intense, violent suicidal preoccupation after 2-7 weeks of fluoxetine treatment. The state persisted for as little as 3 days to as long as 3 months after discontinuation of fluoxetine. None of these patients had ever experienced a similar state during treatment with any other psychotropic drug.”

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High doses of antidepressants ‘double chances of suicidal behaviour in teens’
Study: http://archinte.jamanetwork.com/article.aspx?articleid=1863925

High starting doses of antidepressants such as Prozac have been linked to increased suicidal behaviour in children and young adults, say scientists.

A meta-analysis of various antidepressant drug trials by the US Food and Drug Administration (FDA) found that young people who received antidepressants were twice as likely to have suicidal thoughts or self-harm as those given a placebo.

The study collected data from 162,625 people between the ages of 10 to 64 who had been proscribed antidepressants at modal (the most prescribed on average) or above modal doses, and compared the two groups.

Those aged 24 or younger that started treatment at higher doses was twice as likely to self-harm, with older patients remaining unaffected. The authors of the study suggest that this corresponds to approximately one additional case of self-harm for every 150 patients.

The doctors who conducted the study from the Harvard School of Public Health recommended that doctors should avoid high doses for younger individuals as the benefits are at best “modest”.

A similar study conducted by the British Medical Journal in 2009 also found that young adults taking antidepressants such as SSRIs had double the risk of suicidal thoughts or behaviour when compared to those taking placebos.

SSRIs are a type of antidepressant marketed under many different commercial names including Prozac, Zoloft, Paxil and Seroxat.

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Antidepressants Raise Violence Risk in Young People: Study

http://www.newsmax.com/Health/Health-News/antidepressants-raise-violence-risk/2015/09/15/id/691712/?ns_mail_uid=14650533&ns_mail_job=1635646_09152015&s=al&dkt_nbr=pdm99tyv

STUDY LINK http://journals.plos.org/plosmedicine/article?id=10.1371/journal.pmed.1001875

(Copyright AP) Tuesday, 15 Sep 2015 05:53 PM
Young people taking antidepressants such as Prozac and Seroxat are significantly more likely to commit violent crimes when they are on the medication, but taking higher doses of the drugs appears to reduce that risk, scientists said on Tuesday.

In research published in the PLoS Medicine journal, the scientists said that while their finding of a link does not prove that such drugs cause people to be more violent, further studies should be conducted and extra warnings may be needed in future when they are prescribed to people aged 15 to 24.

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Children given antidepressants are twice as likely to become suicidal, claims new study

http://www.independent.co.uk/news/science/children-given-antidepressants-are-twice-as-likely-to-become-suicidal-claims-new-study-a6838291.html

Researchers looked at clinical trial reports and the raw data relating to more than 18,500 patients

The risk of suicidal or aggressive behaviour was at least double for those under the age of 18

Children and adolescents are twice as likely to exhibit suicidal or aggressive behaviour if they take commonly prescribed antidepressants, according to a new study.

Researchers also found that reports on clinical trials by drug companies frequently downplayed the most serious side-effects, which they only discovered by looking at the raw patient data.

Study corresponding to this article:

Suicidality and aggression during antidepressant treatment: systematic review and meta-analyses based on clinical study reports
http://www.bmj.com/content/352/bmj.i65

British Medical Journal
Published 27 January 2016
Abstract: Objective To study serious harms associated with selective serotonin and serotonin-norepinephrine reuptake inhibitors…
Main outcome measures Mortality and suicidality. Secondary outcomes were aggressive behaviour and akathisia.
Data sources Clinical study reports for duloxetine, fluoxetine, paroxetine, sertraline, and venlafaxine obtained from the European and UK drug regulators, and summary trial reports for duloxetine and fluoxetine from Eli Lilly’s website…
Results We included 70 trials (64 381 pages of clinical study reports) with 18 526 patients… Differences in mortality (all deaths were in adults, odds ratio 1.28, 95% confidence interval 0.40 to 4.06), suicidality (1.21, 0.84 to 1.74), and akathisia (2.04, 0.93 to 4.48) were not significant, whereas patients taking antidepressants displayed more aggressive behaviour (1.93, 1.26 to 2.95). For adults, the odds ratios were 0.81 (0.51 to 1.28) for suicidality, 1.09 (0.55 to 2.14) for aggression, and 2.00 (0.79 to 5.04) for akathisia. The corresponding values for children and adolescents were 2.39 (1.31 to 4.33), 2.79 (1.62 to 4.81), and 2.15 (0.48 to 9.65). In the summary trial reports on Eli Lilly’s website, almost all deaths were noted, but all suicidal ideation events were missing, and the information on the remaining outcomes was incomplete.
Conclusions Because of the shortcomings identified and having only partial access to appendices with no access to case report forms, the harms could not be estimated accurately. In adults there was no significant increase in all four outcomes, but in children and adolescents the risk of suicidality and aggression doubled. To elucidate the harms reliably, access to anonymised individual patient data is needed.

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Children at ‘double the risk of aggression, suicide’ with antidepressant use
http://www.medicalnewstoday.com/articles/305676.php
Written by Yvette Brazier
Published: 01-28-16

In the US, it is estimated that 1.2% of people under 18 years of age were taking prescription antidepressants in 2009-2012.

Selective serotonin reuptake inhibitors (SSRIs) and serotonin-norepinephrine reuptake inhibitors (SNRIs) are the most commonly prescribed drugs for depression.

However, there have been reports of deaths, suicide and violence by people taking these drugs. In the US, the Food and Drug Administration (FDA) have warned of antidepressants leading to suicide among young adults aged 18-24 years.

The FDA recommend monitoring for all patients taking antidepressants to check for worsening of symptoms, suicidal tendencies and any unusual changes in behavior.

Poorly designed studies mask potential dangers

Previous studies of the risks have been poorly designed and findings have been misreported. As a result, it is not known exactly how serious the dangers relating to antidepressant use are for adults or children. Potential risks include aggression, suicidal tendencies and fatality.

A team of researchers from Denmark, concerned about the dearth of published evidence of harms associated with antidepressants, decided to analyze clinical study reports and summary trial reports to gain more information.

The team procured clinical study reports for duloxetine, fluoxetine, paroxetine, sertraline and venlafaxine from British and European regulatory agencies. Summary trial reports for duloxetine and fluoxetine were accessed through the website of the drug company Eli Lilly.

The researchers systematically reviewed 68 clinical study reports of 70 trials involving 18,526 patients to learn more about the risks, which include deaths, suicidal ideation, suicide attempts and aggression. They also looked at akathisia, a type of restlessness that can contribute to violence and suicide.

The trials that were selected featured patient narratives or lists of harms experienced by individual patients.

Previous studies failed to report adverse effects of antidepressant use

In adults, antidepressants did not appear to be linked to suicide and aggression.

In children, however, the risk of suicide and aggression was doubled. Results also showed that previous trials had failed to report adverse effects and were marred by design faults. Comparisons between clinical study results and data from listings or patient narratives showed that deaths and suicide had been wrongly classified for people using antidepressants.

One pharmaceutical company misreported four deaths in favor of the antidepressant, and over 50% of suicidal incidents were put down to “emotional lability” or “worsening of depression.”

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Antidepressants ineffective and harmful for children and teens, major review finds
Sydney Morning Herald
http://www.smh.com.au/national/health/antidepressants-ineffective-and-harmful-for-children-and-teens-major-review-finds-20160609-gpezxx.html

Kate Aubusson/ Health Editor
June 9, 2016

Antidepressants prescribed for children are ineffective and may cause serious harm, including suicide attempts, a major review shows.

The findings had “disturbing implications” for treating major depression in children, warns an Australian psychiatrist, as the use of antidepressants and antipsychotics continues to rise among children as young as two years old.

The risks outweighed the potential benefits of antidepressant use for children for 13 out of 14 antidepressants prescribed to children and teenagers, with only fluoxetine (Prozac) well tolerated, the analysis of 34 clinical trials involving 5260 patients found.

The risks outweigh the benefits for most antidepressants prescribed to children.

The drug venlafaxine (Efexor) was linked with an increased risk of patients experiencing suicidal thought and suicide attempts compared with a placebo, found the most comprehensive review of medications to treat major depression in children and teenager.

But the rate of serious harms linked to other antidepressants, including paroxetine, sertraline, and citalopram may be underestimated due to selective reporting, the burying of unpublished trials showing adverse effects and poorly designed trials, the researchers warned in the review published in The Lancet on Thursday.

The effectiveness of fluoxetine may also have been exaggerated due to the smaller sample sizes of those trials, suggested the international team researchers led by Oxford University psychiatrist Associate Professor Andrea Cipriani.

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PREGNANCY/AUTISM/BIRTH DEFECTS, etc.

Rate of Chiari I malformation in children of mothers with depression with and without prenatal SSRI exposure.
http://www.ncbi.nlm.nih.gov/pubmed/24837031
Neuropsychopharmacology. 2014 Oct;39(11):2611-21
(Mayo Clinic Def: Chiari malformation is a condition in which brain tissue extends into your spinal canal. It occurs when part of your skull is abnormally small or misshapen, pressing on your brain and forcing it downward...)

Selective serotonin reuptake inhibitors (SSRIs) are frequently prescribed to pregnant women. Therefore, research on in utero exposure to SSRIs can be helpful in informing patients and clinicians. The aim of this retrospective two-cohort study was to determine whether there is a statistically significant increase in Chiari I malformations (CIM) in children exposed to SSRIs during pregnancy. A total of 33 children whose mothers received a diagnosis of depression and took SSRIs during pregnancy (SSRI-exposed cohort) were matched to 66 children with no history of maternal depression and no SSRI exposure. In addition, 30 children whose mothers received a diagnosis of depression, but did not receive antidepressants during pregnancy (history of maternal depression cohort), were matched to 60 children with no history of maternal depression and no SSRI exposure. Main outcome was presence/absence of CIM on MRI scans at 1 and/or 2 years of age…
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Taking antidepressants during pregnancy increases risk of autism by 87 percent
Ground breaking study looks at outcomes of 145,456 pregnancies after antidepressant use
https://www.sciencedaily.com/releases/2015/12/151214130227.htm
Science News
December 14, 2015
Using antidepressants during pregnancy greatly increases the risk of autism, Professor Anick Bérard of the University of Montreal and its affiliated CHU Sainte-Justine children’s hospital revealed. Prof. Bérard, an expert in the fields of pharmaceutical safety during pregnancy, came to her conclusions after reviewing data covering 145,456 pregnancies. “The variety of causes of autism remain unclear, but studies have shown that both genetics and environment can play a role,” she explained. “Our study has established that taking antidepressants during the second or third trimester of pregnancy almost doubles the risk that the child will be diagnosed with autism by age 7, especially if the mother takes selective serotonin reuptake inhibitors, often known by its acronym SSRIs.” Her findings were published in JAMA Pediatrics.

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Antidepressants during pregnancy associated with childhood language disorders
http://medicalxpress.com/news/2016-10-antidepressants-pregnancy-childhood-language-disorders.html
October 12, 2016
Mothers who purchased antidepressants at least twice during pregnancy had a 37-percent increased risk of speech and/or language disorders among their offspring compared to mothers with depression and other psychiatric disorders who were not treated with antidepressants, according to new research. Results by scientists at Columbia University’s Mailman School of Public Health and Columbia University Medical Center will be published online in JAMA Psychiatry.

***STUDY Associated with Article Above
Association of Selective Serotonin Reuptake Inhibitor Exposure During Pregnancy With Speech, Scholastic, and Motor Disorders in Offspring
http://jamanetwork.com/journals/jamapsychiatry/article-abstract/2566206
JAMA Psychiatry
October 12, 2016
Question  Is exposure to selective serotonin reuptake inhibitors during pregnancy associated with an increased risk of adverse speech, scholastic, or motor outcomes in offspring?
Meaning  The findings suggest that use of selective serotonin reuptake inhibitors during pregnancy increases the risk of speech/language disorders in offspring.
Results  Of the 56 340 infants included in the final cohort, 28 684 (50.9%) were male and 48 782 (86.6%) were 9 years or younger. The mean (SD) ages of children at diagnosis were 4.43 (1.67), 3.55 (2.67), and 7.73 (2.38) for speech/language, scholastic, and motor disorders, respectively. Offspring of mothers who purchased SSRIs at least twice during pregnancy had a significant 37% increased risk of speech/language disorders compared with offspring in the unmedicated group. ..
Conclusions and Relevance  Exposure to SSRIs during pregnancy was associated with an increased risk of speech/language disorders. This finding may have implications for understanding associations between SSRIs and child development.

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Prozac in Pregnancy May Up Risk of Infant Heart Defects
Meta-analysis finds significant association with first trimester use of drug

Study: http://onlinelibrary.wiley.com/doi/10.1111/bcp.13321/full

  • by Molly Walker
    Staff Writer, MedPage Today May 17, 2017

Infants exposed to fluoxetine (Prozac) in their mother’s first trimester of pregnancy had small but significant increased risks of major malformations and cardiovascular malformations, a small systematic review and meta-analysis found.

Using pooled data from 16 studies, Chinese researchers found statistically significant increased risks of both major malformations (RR 1.18, 95% CI 1.08-1.29) and cardiovascular malformations (RR 1.36, 95% CI 1.17-1.59) on infants exposed to fluoxetine during the first trimester, reported Shan-Yan Gao, MD, of Shenjing Hospital of China Medical University, and colleagues.

However, there were no significant increased risks linked to use of the drug in the first trimester for other system-specific malformations, including the nervous system, eye, urogenital system, digestive system, or musculoskeletal system, the authors wrote in the British Journal of Clinical Pharmacology.

They characterized fluoxetine as “the most commonly prescribed SSRIs [sic] during the first trimester,” and added that in the past five years, a “growing body of cohort studies” have found links between fluoxetine use and the risk of malformations.

Various meta-analyses found conflicting results on the association between use of the drug and both major malformations and cardiovascular malformations in the infant.

But they cited limitations to prior meta-analyses, including the use of case-cohort studies, inaccurate information, unclear adjustments made for confounders and no other evidence for other system-specific malformations.

“The present study is the most comprehensive and current meta-analysis of published cohort studies,” the authors wrote. “The results … suggest healthcare providers and their patients should carefully consider risk-benefit analyses before proceeding with fluoxetine therapy … during the first trimester.”

They examined 16 cohort studies that enrolled a total of 6,562,262 pregnant women. These studies defined the exposure as fluoxetine use and exposure period as the first trimester and who had a comparison group that included pregnant women not exposed to any antidepressants and/or teratogens. Seven of the studies were from Europe and six were from North America. There was no indication of publication bias. Data from 12 studies covered major malformations and cardiovascular malformations in infants with first-trimester fluoxetine exposure.

In addition to the findings for those large classes of defects, data from seven studies showed significant increased risk for certain subtypes of cardiovascular malformation: septal defects (RR 1.38, 95% CI 1.19-1.61) and non-septal defects (RR 1.39, 95% CI 1.12-1.73).

The authors said that most selective serotonin reuptake inhibitors have a short half-life of approximately 1 day, but fluoxetine has a longer half-life (up to 4 days) and “is known to cross the human placenta because high concentrations of fluoxetine are detected in umbilical cord blood,” though they added that “the exact biological mechanism that causes fluoxetine-induced congenital malformations is unknown.”

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Antidepressants Cause Emotional Blunting

Emotional side-effects of selective serotonin reuptake inhibitors: qualitative study
http://bjp.rcpsych.org/content/195/3/211
The British Journal of Psychiatry Aug 2009, 195 (3) 211-217
Background
Some people who take selective serotonin reuptake inhibitor (SSRI) antidepressants report that their experience of emotions is ‘ blunted’. This phenomenon is poorly understood…
This is the first qualitative study of patient experiences of emotional side-effects of SSRIs…
The SSRI group reported significant reductions in 12 of the 18 aspects, including ability to cry, irritation, care about others’ feelings, sadness, creativity, surprise, anger, expression of their feelings and worry…

Emotional side-effects of SSRIs: key themes

General effects on all emotions
Reduced intensity, or even absence of emotions, which are flattened, numbed, dulled or blanked; thoughts rather than feelings; difficulty understanding emotions; emotions feel fake or artificial; improved emotional control
Reduction of positive emotions
Reduced intensity and frequency of e.g. excitement, enjoyment, happiness, love, affection, passion, enthusiasm
Reduction of negative emotions
Reduced intensity and frequency of e.g. sadness, anger, aggression, anxiety and worry. Reduced ability to cry
Emotional detachment
Detachment or disconnection from the environment; from the self; and from other people, including children, partner and friends
Just not caring
Not caring about self, about others, about responsibilities; apathy; reduced interest and motivation; disinhibition; thoughts of self-harm
Changed personality
Aspects of personality are altered or removed; behaviour is out of character
Effects on everyday life
Helpful and/or unhelpful; often helpful initially, but becoming unhelpful as recovery occurs; masking or hiding problems; impact on responsibilities, on own behaviour, on relationships with others, on creativity, on judgement and decision-making
It’s because of my pills!
Emotional side-effects are distinct from emotional illness; vary with dose, with specific medicine, and with adherence; vary with time; and may have an impact on treatment adherence

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ELDERLY DEATH & OTHER PHYSICAL HARM:

 

Warning over newer antidepressants pills

http://www.independent.co.uk/life-style/health-and-families/health-news/warning-over-newer-antidepressants-pills-2331030.html

Study: http://www.bmj.com/content/343/bmj.d4551 you can download study
By Jane Kirby
Wednesday 3 August 2011

Newer antidepressants may increase the risk of serious health problems in older people compared to older pills, researchers say.

Selective serotonin reuptake inhibitors (SSRIs) are more likely to cause death and issues such as heart attack, stroke, falls and seizures than older tricyclic antidepressants (TCAs), according to a study published in the British Medical Journal (BMJ).

Researchers from the universities of Nottingham and East Anglia analysed data for more than 60,000 people diagnosed with depression between 1996 and 2007. All were aged 65 and over.

Those patients not taking any antidepressants had a 7% risk of dying from any cause but this rose to 8.1% for those taking TCAs and 10.6% for SSRIs.

The risk was even higher for other types of antidepressants, at 11.4%.

The risks of stroke and fracture were noticeably higher in those taking SSRIs compared to TCAs and SSRIs were linked to the most falls of any drugs.

The risk to the patient was highest in the first 28 days after starting an antidepressant, and in the first 28 days after stopping taking the drugs.

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Dependency and Withdrawal Effects:


Eli Lilly faces first U.S. trials over Cymbalta withdrawal

NEW YORK | By Jessica Dye
http://www.reuters.com/article/2015/08/03/us-eli-lilly-cymbalta-trial-idUSKCN0Q825220150803
Mon Aug 3, 2015 4:16pm EDT

Eli Lilly & Co on Tuesday will confront the first U.S. trial over allegations it failed to warn users of its popular antidepressant Cymbalta that they could suffer severe withdrawal symptoms, including suicidal thoughts and electric shock-like sensations.

Plaintiff Claudia Herrera is one of about 250 people who have sued Lilly over Cymbalta, and the company faces three more trials later this month involving similar claims, according to a lawyer for Herrera, R. Brent Wisner.

These early trials will be a critical test for litigation over the drug, which had $3.9 billion in sales in 2013 before losing patent protection at the end of that year and brought in $561 million in the first half of 2015.

Cymbalta, part of a class of antidepressants known as serotonin and norepinephrine reuptake inhibitors, was approved by the U.S. Food and Drug Administration in 2004 to treat major depressive disorder. Later, approval was expanded to include generalized anxiety disorder and fibromyalgia.

Its label warns that 1 percent or more of users who discontinue Cymbalta may experience symptoms like nausea, irritability and insomnia, and that other symptoms such as sensory disturbances and seizures had been reported.

But plaintiffs suing Lilly allege that withdrawal symptoms are far more common, pointing to a 2005 analysis from the Journal of Affective Disorders that found more than 44 percent of patients reported at least one discontinuation symptom.

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Brain Zaps: Causes & Treatments For Electrical Shock Sensations
(caused by antidepressant withdrawal)
Mental Health Daily, Nov 29, 2014
Brain zaps are commonly reported electrical shock sensations that are often experienced during discontinuation of antidepressant medications. Other common names for brain zaps include: brain shivers, electrical shocks, and brain shocks. People often describe them as feeling electrical current uncontrollably zapping their brains, which can be extremely frightening and uncomfortable. A person experiencing these zaps may get dizzy, feel minor pain, and high levels of discomfort.

What Causes Brain Zaps?
Brain zaps are considered to be caused by neurotransmitter alterations within the brain, particularly those involving “serotonin.” It is believed that serotonin plays a vital role in the development of these zaps due to the fact that people typically experience them when discontinuing serotonergic antidepressants (e.g. SSRIs). The zaps may also be caused via discontinuation of other psychotropic medications including: antipsychotics, benzodiazepines, MAOIs, SNRIs, and tricyclic antidepressants.

  • Antidepressant withdrawal: During withdrawal from antidepressant medications, “brain zaps” are considered common symptoms to experience. It is believed that the severity and length of brain zaps may be related to whether a person discontinues “cold turkey” as opposed to tapering off of their medication.
  • Eye movements: It has been speculated that moving the eyes side to side may provoke or intensify brain zap sensations. While this is purely speculation, there are online accounts of individuals that found things like “looking to the side” can trigger them.
  • Medication side effects: Some individuals have reported experiencing “brain zaps” as side effects from certain medications. These may be experienced when a person initially begins taking a psychotropic medication. It is thought that adjustments in the functioning of various neurotransmitters are responsible for the zaps.
  • Skipping a dose: If you are on a medication and you accidentally miss or intentionally skip a dose, you may notice unpleasant brain zaps. When people experience the zap sensation, they quickly remember that they forgot to take their medication.
  • Other medications: It should be mentioned that medications other than antidepressants can cause brain zaps. While they are most commonly experienced as a result of taking serotonergic antidepressants, benzodiazepines and antipsychotics have also been suggested as potential causes.

How long do brain zaps last?
There is no set “timeline” that says how long brain zaps will last…

What do Brain Zaps Feel Like?

They are relatively difficult to describe because they affect each person differently. For some they are more severe and resemble electrical jolts, while for others they are less severe and easier to cope with. Most would agree that they feel some sort of “electrical” sensation within their head as a result of them. Below is a list of various descriptions of the zaps based on first-hand experiences.

Descriptions:

  • Electrical shocks
  • “Flicking cards” through your head
  • Electrical jolts
  • Light-bulb going off in your head
  • Lightning strikes in the brain
  • “Pop rocks” in the head
  • Pulses of electricity
  • Shivers of the brain
  • Strobe light flashing in the brain

Note: These sensations are often accompanied by sensations of dizziness and/or vertigo. Others may experience symptoms of nausea and/or tinnitus (ringing in the ears)…

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Stopping SSRI Antidepressant Can Cause Long, Intense Withdrawal Problems
http://www.madinamerica.com/2015/02/stopping-ssri-antidepressants-can-cause-long-intense-withdrawal-problems/

In The News February 23, 2015

In the first systematic review of withdrawal problems that patients experience when trying to get off SSRI antidepressant medications, a team of American and Italian researchers found that withdrawing from SSRIs was in many ways comparable to trying to quit addictive benzodiazepine sedatives and barbiturates. Publishing in Psychotherapy and Psychosomatics, they also found that withdrawal symptoms can last months or even years, and entirely new, persistent psychiatric disorders can emerge from discontinuing SSRIs.

The authors analyzed 15 randomized controlled studies, 4 open trials, 4 retrospective investigations and 38 case reports of SSRI withdrawal. They found that paroxetine (Paxil) was the worst, but that all the SSRI antdepressants could cause a wide range of withdrawal symptoms from dizziness, electrical shock sensations and diarrhea to anxiety, panic, agitation, insomnia and severe depression.

The prevalence of such withdrawal syndromes was “variable” and difficult to estimate from the studies, they wrote, but generally seemed very common. “Symptoms typically occur within a few days from drug discontinuation and last a few weeks, also with gradual tapering. However, many variations are possible, including late onset and/or longer persistence of disturbances. Symptoms may be easily misidentified as signs of impending relapse.”

“Clinicians need to add SSRI to the list of drugs potentially inducing withdrawal symptoms upon discontinuation, together with benzodiazepines, barbiturates, and other psychotropic drugs,” they concluded. “The term ‘discontinuation syndrome’ that is currently used minimizes the potential vulnerabilities induced by SSRI and should be replaced by ‘withdrawal syndrome’.”

An accompanying editorial noted that, “This type of withdrawal consists of: (1) the return of the original illness at a greater intensity and/or with additional features of the illness, and/or (2) symptoms related to emerging new disorders. They persist at least 6 weeks after drug withdrawal and are sufficiently severe and disabling to have patients return to their previous drug treatment. When the previous drug treatment is not restarted, post-withdrawal disorders may last for several months to years.”

The editorial also stated that, “With SSRI withdrawal, persistent postwithdrawal disorders may appear as new psychiatric disorders, in particular disorders that can be treated successfully with SSRIs and SNRIs. Significant postwithdrawal illnesses found with SSRI use include anxiety disorders, tardive insomnia, major depression, and bipolar illness.”

While the study authors found no difference between gradual tapering over relatively short periods and abrupt discontinuation of SSRIs, the editorial authors argued that there was evidence to suggest benefits to tapering.

Chouinard G, Chouinard V, -A, New Classification of Selective Serotonin Reuptake Inhibitor Withdrawal. Psychother Psychosom 2015;84:63-71. DOI:10.1159/000371865 (Abstract and full text)

Fava, G.A., A. Gatti, C. Belaise, J. Guidi, and E. Offidani. “Withdrawal Symptoms after Selective Serotonin Reuptake Inhibitor Discontinuation: A Systematic Review.” Psychotherapy and Psychosomatics 84, no. 2 (2015): 72–81. (Abstract and full text)

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DATA FROM “POWER TO HARM”
(John Cornwell, The Power to Harm, Penguin Books, 1996, Preface) – Prozac exposed

AN EARLY MASS KILLING RELATED TO THE NEW ANTIDEPRESSANTS

“On September 14, 1989, Joseph T. Westbecker, a forty-seven-year-old pressman returned to Standard Gravure, his former place of work in Louisville, Kentucky, and shot 20 of his co-workers, killing eight and injuring twelve, before committing suicide in front of the pressroom supervisor’s office.

“It was discovered soon afterward that Westbecker had been taking a course of the antidepressant Prozac. Thus, Eli Lilly of Indianapolis, the manufacturer and distributor of the drug, became a prime target in a subsequent liability suit brought by the survivors and trelatiives of the dead.”

MAKING THE PROZAC STUDIES ACCEPTABLE TO THE FDA BY RE-WORDING

“One item involved a November 1990 report by the German affiliate chief, Claude Bouchy, expressing his ‘great concerns’ in response to the request of Lilly executives that the phrase ‘suicidal ideation’ be changed to ‘depression’ in data on suicidality: ‘I do not think I could explain to the BGA [the German government’s drug-regulatory body], to a judge, to a reporter, or even to my family why we would do this,’ the document read, ‘especially on the issue of – sensitive issue of suicide and suicidal ideation, at least not with the explanations that have been given our staff so far.’”

“Eventually Zettler asked, ‘Do you have any criticisms about the way the data from overseas was gathered and reported?

“‘Yes,’ she responded with gusto. ‘At one point in 1984, Eli Lilly received word from the German authorities that they were not going to approve this drug because of their concern with the suicidality and agitation. They said that people became agitated before the antidepressant effects came on, and that increased the risk of suicide. They wrote a memo concerning untoward, damaging effects and Lilly then went over there and looked at the data again and pulled out cases that they didn’t think were suicide.

“Lord let this sink in for a moment. ‘First of all,’ she continued, ‘how are they to know? The investigator thought it was a suicide attempt. They said , well they don’t think it is….’ The British and the Danish, she added were similarly concerned about safety, but Lilly reacted in a like manner.”

(Quotes taken from book by John Cornwell, The Power to Harm, Penguin Books, 1996)

THE USE OF OTHER DRUGS TO MASK SIDE EFFECTS IN PROZAC DRUG TRIALS

“After the court reconvened, Zettler again asked about the effect of concomitant medications in Prozacs clinical trials. Various witnesses had tackled this question before, but Lord’s approach, loaded with qualifying detail, was devastating.

“‘To simply sedate them, make those things [adverse events] less of a problem and then not report them, was in my opinion improper,’ she said to a hushed court. She was not referring, she added, to aspirin or antibiotics. ‘Those sorts of things are expected. But in this case, they regularly, systematically, and in a large portion of the people used tranquilizers, sedatives, to calm people down. It happened in very high percentages of people in the study, and it completely obscured what this product was doing to people’s minds.’”

(Quotes taken from book by John Cornwell, The Power to Harm, Penguin Books, 1996)

DURING THE TRIAL REGARDING ELI LILLY’S CULPABILITY FOR WESTBECKER’S MASS SHOOTING WHILE TAKING PROZAC, LILLY’S LAWYERS SECRETLY SETTLED WITH ALL THE PLAINTIFF’S UNDER THE CONDITION THAT THEY CONTINUE THE TRIAL, THEIR LAWYERS NOT BRING UP CERTAIN DAMNING INFORMATION BEFORE THE JURY AND THAT THE JURY, JUDGE AND PUBLIC NOT BE TOLD OF THE SETTLEMENT. AFTER LILLY APPEARED TO WIN THE JURY’S VERDICT THEY PUBLICIZED THEIR WIN AND PROZAC’S EXONERATION IN THE MEDIA AND TO DOCTORS ACROSS THE COUNTRY. HOWEVER, THE RUMORS THAT LILLY HAD SETTLED THE CASE WERE EVENTUALLY CONFIRMED.

“Attempts to deny the existence of a financial settlement were finally swept away in July, when it was revealed that plaintiff Andrew Pointer, shot [by Joseph Westbecker on Prozac] in the tunnel between Standard Gravure and the Currier-Journal building, had been obliged to divulge his earnings in a divorce settlement. Without revealing the actual figure, his lawyer declared publically that he was receiving a huge payment from Lilly, in three parts.

(Quotes taken from book by John Cornwell, The Power to Harm, Penguin Books, 1996)

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