New Safety Concerns Identified For 1 in 3 FDA-Approved Drugs


Source: News.Yale.edu
Ziba Kashef
May 9, 2017

Nearly one out of every three drugs approved by the Food and Drug Administration (FDA) have a new safety issue detected in the years after approval, says a Yale-led study. While most of the safety concerns are not serious enough to require withdrawal of a drug from the market, the finding highlights the need for ongoing surveillance of new drugs in the post-market period, said the researchers.

The findings were published May 9 in the Journal of the American Medical Association (JAMA).

To assess new drugs for safety and effectiveness, the FDA relies on premarket drug testing and clinical trials. Most of the trials involve fewer than 1,000 patients studied over a period of six months or less, making it difficult to detect safety issues that might be identified once more patients use the drug over a longer time period. To identify factors that might enhance patient safety and regulatory surveillance efforts, the Yale-led team analyzed data on new drugs approved between 2001 and 2010, with follow up through 2017.

The research team, led by associate professor of medicine and public health Dr. Joseph Ross, found that 32% of new drugs were flagged for a safety issue after approval. “That is very rarely a drug withdrawal, but more commonly a black box warning, or drug safety communication issued by the FDA to let physicians and patients know that new safety information has been determined,” said Ross.

The researchers also identified characteristics of drugs that were more likely to be associated with a safety concern, including biologic therapies and drugs that were approved through the FDA’s accelerated approval pathway.

While the study results point to the need for ongoing monitoring of newly approved drugs, they also demonstrate that the FDA’s current process is working. “The fact that the FDA is issuing safety communications means it is doing a good job of following newly approved drugs and evaluating their safety up in the post-market period,” Ross noted.

At a time when the FDA is under pressure to accelerate drug approvals, the study findings provide key information about the agency’s process. “It shows that there is the potential for compromising patient safety when drug evaluation is persistently sped up,” said Ross. At the very least, the study should inform ongoing debate about premarket drug evaluation, the researchers said.

Other authors on the study are Nicholas Downing, Nilay Shah, Jenerius Aminawung, Alison Pease, Jean-David Zeitoun, and Harlan Krumholz. All authors have completed the ICMJE Form for Disclosure of Potential Conflicts of Interest, which are detailed in the study.

There was no funding for this research.

Read More At: News.Yale.edu

Bombshell Study Admits Antidepressants Increase Suicide Attempts In Teens & Are Completely Worthless For Treating Depression

Antidepressants
Source: NaturalNews.com
Julie Wilson
June 13, 2016

A bombshell study published in the medical journal The Lancet admits what Natural News and others in the holistic health community have been reporting for years: antidepressants kill. On Wednesday, researchers published the most comprehensive analysis to date of the safety and efficacy of widely prescribed antidepressants in children and teens.

What they found is that the majority of antidepressants prescribed to young people have far more risks than benefits, doing essentially nothing to ease symptoms of depression, while significantly increasing suicidal thoughts and suicide attempts, CBS News is reporting.

Out of 14 antidepressants analyzed by researchers, only one – fluoxetine (marketed under the name Prozac and Sarafem) – proved effective for relieving symptoms of depression better than a placebo pill. Venlafaxine (Effexor), on the other hand, was shown to increase the risk of suicidal tendencies in children and teens compared to a placebo and five other antidepressants.

The study results are major considering the fact that antidepressant use among young people is at an all-time high. Shockingly, children under 5-years-old are the fastest growing group being prescribed mind-altering drugs.

Most antidepressants do NOTHING to help depression, study finds

Antidepressant use among children and teens rose from 1.3 to 1.6 percent between 2005 and 2012, according to a separate study published in The Lancet.

As the authors of this latest study confirm, the implications of drugging children with powerful, mind-altering drugs is completely unpredictable, which is why international guidelines encourage doctors to use non-drug approaches including “cognitive behavioral or interpersonal therapy.”

Lead study author Dr. Andrea Cipriani says that because brains in children and teens are not yet developed, it’s important to lead with caution when prescribing medication, “because we don’t know the potential implications in the long term … .”

The U.S National Institutes of Health estimates that some 2.8 million children (or about 11 percent) between the ages of 12 and 17 have suffered from at least one episode of depression, for which we now know that antidepressant drugs are totally worthless.

Dr. Cipriani explains that depression in children differs widely from that of adults. “Not only is it still under-diagnosed and under-treated but also it tends to present in a different way,” he said. “Depressive symptoms in children and adolescents are rather undifferentiated. You notice more irritability, aggressive behavior and problems at school. And consequences of depressive episodes in children and adolescents are dramatic because they include impairments in their social functioning but also an increased risk of suicidal ideation and attempts.”

FDA privy to antidepressant harm in children for decades

The U.S. Food and Drug Administration has known for more than a decade that antidepressants pose immense harm to patients, particularly children, which is why it implemented “black box” warnings in 2004 for users under the age of 24. The labels clearly state that the drugs up your chances of becoming suicidal or intensify preexisting suicidal thoughts and behavior.

Yet, irresponsible physicians continue to push harmful drugs on children and teens that alter brain chemistry. Not only that, but doctors are increasingly prescribing the drugs for off-label uses.

This was substantiated just weeks ago in a study published in the May issue of the Journal of the American Medical Association (JAMA), which found that nearly half of people prescribed antidepressants aren’t even depressed.

After analyzing a decade of antidepressant prescription records, researchers concluded that only 55 percent were given for depression, while the remaining 45 percent was written for conditions such as anxiety, sleeping problems, pain, panic disorders and attention deficit hyperactivity disorder (ADHD).

Doctors prescribing depression pills for pretty much anything

Other off-label uses include digestive problems, eating disorders, migraines and menopausal symptoms. Twenty-nine percent of antidepressant prescriptions were written for off-label uses. The study authors expressed grave concerns about the fact that these drugs, which are proven to be dangerous, are being prescribed for conditions for which there is no evidence supporting their efficacy, or safety for that matter.

The reason doctors are pushing unproven drugs, is because they’re being advised to do so by Big Pharma, and not by scientific research, said the study authors.

Further illustrating just how worthless these drugs are, medical researcher Peter Gotzsche said last year that nearly all psychiatric drugs, including antidepressants, could be withdrawn from the market without damaging public health. In fact, he recommends it.

Read More At: NaturalNews.com

Medical Journal Openly Admits 50% Of People On Antidepressants Don’t Even Have Depression

Antidepressants
Source: NaturalNews.com
David Gutierrez
June 7, 2016

Nearly half of people taking depressants are not suffering from depression at all, according to a study conducted by researchers from McGill University in Montreal, and published in the Journal of the American Medical Association (JAMA).

These people have been prescribed the drugs for “off label” uses not approved by drug regulatory agencies. These uses have never been proven safe or effective.

“It’s an interesting phenomenon,” author Jenna Wong said. “We had heard that in the scientific community there has been a suspicion among doctors that physicians are commonly prescribing antidepressants for uses other than depression. We also found that for the major classes of antidepressants, there was an increasing prescribing trend over time.”

Treatments not backed by evidence

The researchers reviewed 10 years of antidepressant prescription records, containing data on more than 100,000 prescriptions written by approximately 160 doctors for nearly 20,000 patients. They analyzed trends of prescribing for every antidepressant class except monoamine oxidase inhibitors, which are almost never prescribed as antidepressants anymore and therefore rarely occurred in the records.

They found that only 55 percent of the prescriptions were written for depression. The other 45 percent were written for anxiety (18.5 percent), insomnia (10 percent), pain (6 percent), panic disorders (4 percent), and for a slew of conditions that are off-label for every antidepressant, including attention deficit hyperactivity disorder (ADHD), digestive disorders, eating disorders, migraine and vasomotor menopause symptoms.

Twenty-nine percent of antidepressant prescriptions were written for a use that was off-label for that particular drug. Fully 66 percent of prescriptions written for conditions other than depression were off label.

If nothing else, the study shows that rates of antidepressant prescriptions are a not a good indicator of the rate at which depression is being diagnosed, or treated, the authors noted. It also raises concerns that the drugs are being so widely used for conditions not backed by scientific research.

“The findings indicate that the mere presence of an antidepressant prescription is a poor proxy for depression treatment, and they highlight the need to evaluate the evidence supporting off-label antidepressant use,” the authors wrote.

Deadly placebos

Wong noted that off-label uses have never been proven effective, and may also carry a risk of unknown side effects.

“I can’t make a statement to say that for sure they don’t work or that they are exposing patients to health risks but there’s the possibility that they could be causing adverse health effects or that they may not be effective for the conditions,” Wong said. “Without any scientific evidence, it’s hard to be able to say.”

“It raises the question of why they are prescribing them,” she said.

The authors speculated that many doctors are relying on tradition or informal channels of information, rather than scientific research.

“Physicians may be talking to their colleagues and saying, ‘Hey, I’ve used this drug in my patient population and it works,'” Wong said. “So it’s more word of mouth.”

Other potential reasons for off-label prescribing may be marketing by pharmaceutical companies or simply the use of antidepressants as a last resort when other treatments have failed.

“Some of these conditions are things where there is no exact treatment,” Wong said. “The patients may be desperate for something to treat their ailments.”

The findings are particularly troubling given how many studies have shown that antidepressants have little, if any, benefit over a placebo – but with a much higher rate of potentially dangerous side effects, including suicide.

In an article published last year in the British Medical Journal, esteemed evidence-based medicine researcher Peter Gotzsche argued that nearly all psychiatric drugs, including antidepressants, could be discontinued without harming public health. In fact, he said, there would probably be a benefit; currently, these drugs kill 500,000 people per year – and that’s just for people over the age of 65 living in Western countries.

Read More At: NaturalNews.com