Adverse Effects

New research published in the July issue of The Journal of Clinical Psychiatry found that the use of mood stabilizers, antipsychotics, antidepressants, and hypnotics during pregnancy is associated with increased health risks to the infant.

It is appropriate to hold a company or doctors who may be aiming to make money out of vulnerable people to a high standard when it comes to efficacy, but for those interested to advance the treatment of patients with any medical condition it is not appropriate to deny the likely existence of harms on the basis of a failure to reach a significance threshold that the very process of conducting an RCT will mean cannot be met, as investigators' attention is systematically diverted elsewhere.

Individuals between the ages of 15 and 24 are more likely to commit a violent crime if they are taking an SSRI antidepressant than if they are not, according to new research out of Sweden. The study published in PLoS Medicine on Tuesday, suggests "warnings about the increased risk of violent behavior among young people taking SSRIs might be needed.”

Huffington Post and journalist Steve Brill have combined to launch a 15 part series about how Johnson & Johnson illegally violated FDA restrictions by pushing the antipsychotic drug, Risperdal, for use with adolescents and the elderly. The series, entitled “America’s Most Admired Lawbreaker,” launched yesterday and will include mixed media, videos, podcasts, source documents, as well as 15 written chapters. Click more for a synopsis of part 1.

In 1980, the British Medical Journal published a “Systematic Review of the Benzodiazepines” by the Committee on the Review of Medicines. The committee denied the addictive potential of Benzodiazepines and limited their suggestions to short term use. The results have been devastating.

Writing for the UK’s Daily Mail, Peter Gøtzsche introduces his new book “Deadly Psychiatry And Organised Denial.” “More than 80 million prescriptions for psychiatric drugs are written in the UK every year, Gøtzsche writes. “Not only are these drugs often entirely unnecessary and ineffective, but they can also turn patients into addicts, cause crippling side-effects - and kill.”

“In Gallup's annual measure of 25 major U.S. business sectors, the percentage of Americans with a positive view of the pharmaceutical industry dropped from 40% in 2014 to 35% this year, while the percentage with a negative view rose from 36% to 43%.”

In exchange for pleading guilty to murder, a young soldier received a 45-year sentence with the possibility of parole. The plea resulted from evidence that Chantix, a smoking cessation drug manufactured by Pfizer, can increase hostility and agitation, according to the SunHerald. “Several experts provided some evidence that Chantix affected (the soldier’s) ability to appreciate the nature and quality or wrongfulness of his acts,” the SunHerald noted.

When Wilda White recovered from a manic episode triggered by her ADHD medication, she had lost her relationship, her home, and her dream job as a public interest lawyer. She reached a turning point when, she told Seven Days newspaper, "in the course of trying to figure out what had happened to me, I went on the website Mad in America.” Through the site, she connected with a job listing from Vermont Psychiatric Survivors, a non-profit dedicated to empowering and protecting the rights of people labeled “mentally ill.” She is now their executive director.

According to an analysis by the Washington Post, “On average, police shot and killed someone who was in mental crisis every 36 hours in the first six months of this year.” Chuck Wexler, executive director of the Police Executive Research Forum called it “a national crisis.” “We have to get American police to rethink how they handle encounters with the mentally ill. Training has to change.”

Amid growing criticism about the over-prescription of psychotropic medication in foster care, Pennsylvania commissioned PolicyLab to conduct an analysis of the use of psychiatric drugs among all of the state’s Medicaid-enrolled children. The report, released in June, found that the rate of psychotropic prescriptions among youth in Medicaid and foster care was higher than previously reported.

Antipsychotics are currently the predominant treatment for individuals diagnosed with schizophrenia, but there is an accumulating body of research that links the use of these drugs to structural abnormalities in the brain. A recent meta-analysis suggests that gray matter loss in the brain may depend on the dose and class of the antipsychotic.

Antipsychotics are being prescribed to people who may have challenging behaviors but no mental disorder, according to new research published in this month’s issue of BMJ. “Excessive use of psychotropic drugs has individual and systemic implications,” the researchers write. “Antipsychotics, in particular, are associated with several adverse side effects that can impair quality of life and lead to deleterious health outcomes.”

New research finds that brain matter loss in patients diagnosed with schizophrenia is correlated with antipsychotic use, according to Psych Central. The analysis suggests that the continued use of antipsychotics is linked with progressive cortical gray matter loss.

Psych Central covers findings published in BMJ revealing that many people in the U.K. with intellectual disabilities are being prescribed antipsychotic drugs. The study’s lead author comments: “People who show problem behaviors, along with older people with intellectual disability or those with co-existing autism or dementia, are significantly more likely to be given an antipsychotic drug, despite this being against clinical guidelines and risking possible harm.”

This month’s issue of JAMA Psychiatry ran an editorial commenting on recent research revealing that the majority of youth prescribed antipsychotics have not been diagnosed with a mental disorder.

In the September issue of The Journal of the American Medical Association (JAMA) three FDA advisory committee members describe the convergence of factors that made the committee’s recommendation to approve flibanserin especially challenging and politically charged.

In addition to hosting the Panorama programs and The Famous Grouse history of Study 329, Study329.org has a comprehensive timeline on the origins of concerns about the SSRIs and the risk of suicide, initially with Prozac and subsequently with Paxil/Seroxat. The hope is to provide a comprehensive repository for anyone who wants to study SSRIs, RCTs, and Study 329 in particular.

MedPageToday reports that Janssen Pharmaceuticals omitted data from a 2003 study that connected Risperdal with serious side effects. Janssen was previously sued by the FDA for marketing Risperdal for off-label uses and settled for $2.2 billion in 2013. Earlier this year, a man with autism was awarded $2.5 million after growing breasts while on Risperdal. According to MedPage, documents from this latest case reveal missing data tables from a 2003 study “designed to ferret out potential adverse effects of long-term risperidone use.” The missing tables were related to elevated prolactin levels and side effects, including gynecomastia in men.

Writing for Forbes, Matthew Herper documents the FDA’s increasing drug approval rates. “In 2008, BioMedTracker says the FDA approved 20 new molecular entities (NMEs) and rejected 20, for an approval rate of 50%.” So far this year, he writes, “the FDA approval rate is more like 96%.”

Bertha Madras, professor of psychobiology at Harvard Medical School, has printed a critique listing 20 flaws to a recent study finding no differences in physical or mental health problems between users and non-users of marijuana.

The Australian reports that their Therapeutic Goods Administration (TGA) received new data from drug company Janssen-Cilag, the developers of risperidone, “indicating a more than fivefold higher risk of ‘cerebrovascular adverse events’ — stroke or transient ischaemic ­attack — in patients with vascular or mixed dementia on risperidone.”

The US Food and Drug Administration has announced that there will soon be a public meeting to explore providing drug companies with greater flexibility in promoting off-label indications to doctors. When it comes to prescribing medications to children, and particularly psychiatric medications, this is a bad idea. I write both as a former consultant to the pharmaceutical industry, and as a father who lost a son to the toxic effects of antipsychotics prescribed off-label.

US Food and Drug Administration scientists want to better evaluate side effects of sexual dysfunction associated with antidepressant drugs.

Four different studies conducted in different ways examining different groups have linked use of certain psychiatric drugs to bone fracture risks and negative impacts on human bone development.