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June 13, 2019 by Emmarie Huetteman | Medscape.com

FDA Overlooked Red Flags in Drugmaker’s Testing of New Depression Medicine

(Medscape.com) – Ketamine is a darling of combat medics and clubgoers, an anesthetic that can quiet your pain without suppressing breathing and a hallucinogenic that can get you high with little risk of a fatal overdose.

For some patients, it also has dwelled in the shadows of conventional medicine as a depression treatment — prescribed by their doctors, but not approved for that purpose by the federal agency responsible for determining which treatments are “safe and effective.”

That effectively changed in March, when the Food and Drug Administration approved a ketamine cousin called esketamine, taken as a nasal spray, for patients with intractable depression. With that, the esketamine nasal spray, under the brand name Spravato, was introduced as a miracle drug — announced in press releases, celebrated on the evening news and embraced by major health care providers like the Department of Veterans Affairs.

The problem, critics say, is that the drug’s manufacturer, Janssen, provided the FDA at best modest evidence it worked and then only in limited trials. It presented no information about the safety of Spravato for long-term use beyond 60 weeks. And three patients who received the drug died by suicide during clinical trials, compared with none in the control group, raising red flags Janssen and the FDA dismissed.

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June 12, 2019 by RxISK.org

EMA Acknowledges Persistent Sexual Dysfunction After SSRIs & SNRIs

(RxISK.org) – The European Medicines Agency has just concluded a review into sexual dysfunction after the discontinuation of SSRIs and SNRIs. Before we discuss their findings, it’s worth looking back over the events of the past year.

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June 9, 2019 by Frontiers

Call for submissions: Antidepressant Prescriptions in Children and Adolescents

Abstract submission deadline is June 17; manuscript deadline October 17

Editors Michael P. Hengartner, David Healy, Irving Kirsch

SUBMIT

(Frontiers) – The prescription of antidepressants to children and adolescents is a controversial topic. With respect to depressive disorders, to date no single pediatric antidepressant trial found efficacy on the pre-specified primary outcome (Healy et al., 2019). However, when meta-analytically pooled across all trials, antidepressants appear to have a statistically significant albeit marginally small benefit over placebo (Locher et al., 2017). It also appears that antidepressants are more effective for anxiety disorders than for depressive disorders (Locher et al., 2017). On the other hand, the risk of suicidal events in antidepressant recipients is about twice that seen in placebo recipients, indicating that antidepressants increase the suicide risk in children and adolescents (Sharma et al., 2016).

Another issue related to the risk-benefit conundrum is the influence of the pharmaceutical industry on the design, conduct and publication of pediatric antidepressant trials (Leo, 2006). Systematic biases and even research misconduct have been documented in several industry-sponsored trials, and these flaws further complicate the interpretation of published findings on the usefulness of antidepressants in children and adolescents (Jureidini et al., 2004).

The aim of this Research Topic is to provide a forum to discuss these important issues. Researchers from the field of child and adolescent psychiatry, paediatrics, clinical psychology, social work, public health, sociology, epidemiology, clinical pharmacology and toxicology, and psychopathology, may submit high-quality research.

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June 7, 2019 by Rhiannon Lucy Cosslett | The Guardian

I know antidepressant withdrawal symptoms are real. Why didn’t doctors?

Like many, I’ve experienced severe side-effects from withdrawal. Now clinicians are starting to take them seriously

(The Guardian) – It’s something of a relief to see before you, written down in black and white, what you have known to be true for a long time: in this case, that antidepressant withdrawal symptoms aren’t, well, all in your head. In a significant shift in position, the Royal College of Psychiatrists now accepts that it has not paid enough attention to patients suffering from severe withdrawal symptoms when coming off antidepressants.

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June 6, 2019 by Michael P. Hengartner | Acta Neuropsychiatrica

Scientific debate instead of beef; challenging misleading arguments about the efficacy of antidepressants

(Acta Neuropsychiatrica) – In a recent commentary with the polemic title ‘Antidepressnats; what’s the beef?’, Goodwin and Nutt argued that the benefit-risk ratio of antidepressants had been questioned inappropriately (Goodwin & Nutt, 2019). Personally I think it is a great achievement that our medical system can offer pharmacological treatments to people who suffer from serious clinical depression, and like Goodwin and Nutt I accept that antidepressants may be useful in some patients (Hengartner & Ploderl, 2018). Nevertheless, and this is where my position deviates from Goodwin and Nutt, I am also concerned about the overestimation of efficacy and the minimisation of harm (Hengartner, 2017). There are many misrepresentations in the commentary by Goodwin & Nutt, all of which systematically inflate the apparent benefits of antidepressants, and in this letter, I will discuss five of them.

Full article

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May 31, 2019 by Psychiatric News

Taking Antidepressants After Age 60 May Increase Dementia Risk, Study Finds

(Psychiatric News) – People who take antidepressants after age 60 may face a greater risk of dementia than those who don’t take antidepressants, a study in the American Journal of Geriatric Psychiatry has found.

Arad Kodesh, M.D., of the University of Haifa in Israel and colleagues analyzed the health records of 71,515 people aged 60 years or older from Israel. As far back as 2002, the participants had no diagnosis of dementia or record of taking medications for dementia. No participants had taken an antidepressant in 2012. The researchers then followed the participants from May 2013 to October 2017.

During follow-up, 3,688 participants had received and filled prescriptions for an antidepressant for at least 60 days. Of those, 11% developed dementia. In contrast, only 2.6% of those who did not take antidepressants developed dementia. After adjusting for other conditions linked to dementia risk, the researchers found that the risk of dementia in those who took an antidepressant was 3.43 times greater than those who did not.

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May 29, 2019 by Helen McArdle | The Herald Scotland

U-turn as psychiatrists say patients should be warned of antidepressant withdrawal risk

(The Herald) – PATIENTS prescribed antidepressants should be warned of the potential for “severe and long-lasting withdrawal symptoms” psychiatrists have said.

The revised guidance, issued today by the Royal College of Psychiatrists, marks a major turning point for official advice about the drugs.

Previously the College insisted that the side effects of tapering off antidepressants were “usually mild and self-limiting”, lasting around a week.

However, that has been increasingly challenged by campaigners, researchers, patient groups and parliamentary inquiries at Holyrood, Westminster and the Welsh Assembly which between them gathered evidence from thousands of antidepressants users who had suffered long-lasting or even permanent harm after weaning themselves off antidepressants.

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May 17, 2019 by ED YONG | The Atlantic

A Waste of 1,000 Research Papers

Decades of early research on the genetics of depression were built on nonexistent foundations. How did that happen?

(The Atlantic) – In 1996, a group of European researchers found that a certain gene, called SLC6A4, might influence a person’s risk of depression.

It was a blockbuster discovery at the time. The team found that a less active version of the gene was more common among 454 people who had mood disorders than in 570 who did not. In theory, anyone who had this particular gene variant could be at higher risk for depression, and that finding, they said, might help in diagnosing such disorders, assessing suicidal behavior, or even predicting a person’s response to antidepressants.

Back then, tools for sequencing DNA weren’t as cheap or powerful as they are today. When researchers wanted to work out which genes might affect a disease or trait, they made educated guesses, and picked likely “candidate genes.” For depression, SLC6A4 seemed like a great candidate: It’s responsible for getting a chemical called serotonin into brain cells, and serotonin had already been linked to mood and depression. Over two decades, this one gene inspired at least 450 research papers.

But a new study—the biggest and most comprehensive of its kind yet—shows that this seemingly sturdy mountain of research is actually a house of cards, built on nonexistent foundations.

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May 17, 2019 by Neuroscience News

Inflammation induces anhedonia in women but not men

Inflammation appears to reduce reward response in females. Reduced activity in the brain’s reward system is a key component of anhedonia, the loss of enjoyment in activities, a core feature of depression. The findings may explain why depression is more prevalent in women than in men.

Source: Elsevier

Inflammation reduces the brain’s response to rewards in women, but not in men, according to a new study in Biological Psychiatry: Cognitive Neuroscience and Neuroimaging, published by Elsevier. Reduced activity in the brain’s reward center is the signature of anhedonia, a core feature of depression that reflects a loss of enjoyment in things or activities. Women are two-to-three times more likely to be diagnosed with depression, and the new findings pinpoint a key difference in men and women that could contribute to the lopsided rates of the disorder.

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May 14, 2019 by Peter Simons | MadInAmerica.com

Exposure to Antidepressants in the Womb Linked to Autism

(MadInAmerica.com) – Researchers, publishing in Toxicology Research, review the evidence that antidepressant exposure in the womb is linked to autism spectrum disorders (ASD) in humans. Each of the studies they examined determined that there was a correlation between the drug exposure and risk of autism diagnosis.

The research was led by Xu Wang and Zonghui Yuan at the National Reference Laboratory of Veterinary Drug Residues and the MAO Key Laboratory for Detection of Veterinary Drug Residues in China.

According to the researchers, up to 13.3% of women continue taking antidepressants during pregnancy. They write that “Many antidepressant treatments cross the placenta and are secreted in breast milk, and as a result raise anxiety regarding severe effects on fetal and infant exposure.”

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