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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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June 4, 2019 by RxISK.org

When Asthma leads to Suicide or Homicide

(RxISK.org) – It seems like it’s all happening in Wales at the moment.  Wales Online last week reported on two children who developed suicidal behaviour and change of personalities on montelukast – Singulair.

It was two mother who pieced the story together in the case of their children and confirmed the link to the drug by getting it stopped and seeing the problem clear up.  See below and at the attached link for the online complete with video and photographs.

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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 30, 2019 by Council for Evidence-Based Psychiatry

Campaigning persuades Royal College of Psychiatrists to change its position on antidepressant withdrawal

(Council for Evidence-Based Psychiatry) – Following campaigning by CEP, the All Party Parliamentary Group for Prescribed Drug Dependence and numerous members of the #prescribedharm community, the Royal College of Psychiatrists has today changed its position on antidepressant withdrawal.  It has issued a revised policy statement updating its guidance to doctors, and calls upon NICE to update its guidelines as well.  This follows many months of work by CEP and its members, including the publication of research which indicates that antidepressant withdrawal is more widespread, more severe and more long-lasting than suggested by current guidelines.

Specifically, the College is calling for the following changes:

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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 24, 2019 by Tim Beck, PhD | MadInAmerica.com

Psychotropic Medications Serve as Powerful Tools for U.S. Military, Imperialism

Ethnographic research sheds light on extensive psychopharmaceutical use by soldiers in post 9/11 U.S. wars.

(MadInAmerica.com) – A new study, published in Medical Anthropology Quarterly, overviews a growing phenomenon in the U.S. military referred to as ‘pharmaceutical creep,’ where psychiatric drugs have become circulated throughout deployment zones with increasing regularity. This can range from the non-prescribed distribution of substances like stimulants to increase soldier performance to the prescription of antidepressants in ways that impede military objectives.

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The contents of this Headlines page are provided for informational purposes. Any material, conclusions, or opinions presented in the linked articles are not necessarily endorsed by the Foundation for Excellence in Mental Health Care.