Tag: black box warning

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Researchers Conclude Suicide Warning On Antidepressant Labels Is Justified

Researchers examining the validity of the black box warning on antidepressants have concluded that the warning of the increased risk of suicidal thoughts and actions in children and young adults is clearly justified.

The best evidence available from clinical trials “demonstrated increased risk of suicidality adverse events among youth taking antidepressants,” according to researchers from universities in the United States and Australia, whose findings were published in the journal Frontiers in Psychiatry.

The researchers also examined critics’ claims that the black-box warning led to fewer prescriptions for antidepressants and, as a result, higher rates of suicide and suicide attempts.

Instead, researchers found that the rise in suicidal behavior in children and young adults occurred while prescriptions for antidepressants also increased.

“More recent data suggest that increasing antidepressant prescriptions are related to more youth suicide attempts and more completed suicides among American children and adolescents,” the researchers wrote.

“The black box warning is firmly rooted in solid data, whereas attempts to claim the warning has caused harm are based on quite weak evidence,” they concluded.

A black box warning on a drug label is one of the FDA’s strongest warnings, reserved for drugs that carry significant risk of serious or fatal side effects.

The black box warning on antidepressants was first required by the FDA in 2004 to warn of the increased risk of suicidal thoughts and actions in children and adolescents.  The warning was expanded in 2007 to include young adults.

“When a clear body of evidence points to increased treatment-linked risk, patients and healthcare providers should be made aware of these risks,” the researchers wrote, noting their duty to warn.

WARNING: Anyone wishing to discontinue or change the dose of a psychiatric drug is cautioned to do so only under the supervision of a competent medical doctor because of potentially dangerous, even life-threatening mental and physical withdrawal symptoms.

If you or someone you know has experienced harmful side effects from antidepressants, we want to talk with you.  You can contact us by clicking here or by calling 303-789-5225.  All information will be kept in the strictest confidence.

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News for Colorado

Study Finds Antidepressants Double The Risk Of Suicide And Violence in Adults With No Mental Disorders

A study recently published in the Journal of the Royal Society of Medicine concluded that antidepressants double the risk of events leading to suicide and violence in adults with no signs of any mental disorder.

As the Citizens Commission on Human Rights (CCHR) has been warning for years, the study confirms that antidepressant drugs themselves cause violence and suicide.

The Food and Drug Administration (FDA) requires its most serious black-box warning on all antidepressants to warn that the drugs increase the risk of suicidal thinking and behavior in young adults ages 18 to 24, but the warning does not currently extend to adults older than 24.

The link between antidepressants and violence, witnessed firsthand in Colorado in the deadly actions of Eric Harris at Columbine and James Holmes at an Aurora movie theater, is not yet reflected in any FDA black-box warning.

The new study, which reviewed published clinical trials found in online searches and clinical study reports obtained from European Union and United Kingdom drug regulators, concluded that the harm being caused by antidepressants extends to all age groups and that the harm includes violence.

bullets“While it is now generally accepted that antidepressants increase the risk of suicide and violence in children and adolescents (although many psychiatrists still deny this), most people believe that these drugs are not dangerous for adults,” the study authors wrote.

“This is a potentially lethal misconception.”

The researchers calculated that one of every 16 mentally healthy adults taking antidepressants experienced harm related to suicide or violence.

Warning: Anyone wishing to discontinue an antidepressant or any other psychiatric drug is cautioned to do so only under the supervision of a competent medical doctor because of potentially dangerous withdrawal symptoms.

If you or someone you know experienced violence or suicidal thoughts or actions from taking an antidepressant or any other psychiatric drug, please report it to the FDA by clicking here.  And we want to talk to you about your experience.  You can contact us privately by clicking here or by calling 303-789-5225.  All information will be kept in the strictest confidence.

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News for Colorado Schools

Brighton School District 27J In Violation For Eight Years Of State Law Safeguarding Students

An examination of Brighton School District 27J Board policy by the Citizens Commission on Human Rights of Colorado (CCHR) found that until today, the superintendent’s policy did not contain language prohibiting school personnel from recommending or requiring psychiatric drugs for any student, a policy that has been required by state law since 2003.
This means that for the past eight years, some 15,000 children in the district have not been protected by district policy from teachers, principals and other school personnel pressuring parents to put their children on behavioral drugs, especially ADHD drugs, which may endanger their health and mask the real problems students are experiencing in the classroom.
C.R.S. 22-32-109(1)(ee) requires school district Boards of Education to adopt policy “to prohibit school personnel from recommending or requiring the use of a psychotropic drug for any student.” The law further requires policy that “School personnel shall not test or require a test for a child’s behavior without prior written permission from the parents or guardians or the child and prior written disclosure as to the disposition of the results or the testing therefrom.”
One in nine boys between the ages of 6 and 14 in the U.S. is already being treated with ADD/ADHD drugs (methylpenidate). These drugs are amphetamines, which are highly addictive, which lab rats cannot distinguish from cocaine, and which a government study found greatly increase the risk that children taking them will end up on street drugs – especially cocaine. The last thing we need is schools pressuring parents to pressure their doctors to put even more of our kids on these drugs.
In 2006 the U.S. Food and Drug Administration began to require ADD/ADHD drugs to carry the FDA’s strongest, “black-box” warning that the drugs can cause heart attacks, strokes and sudden death. Cardiologist Steven Nissen, on the FDA advisory panel that recommended this warning, explained the urgency of the warning: “This is out-of-control use of drugs that have profound cardiovascular consequences. We have got a potential public health crisis. I think patients and families need to be made aware of these concerns.”
Drugging may make children easier to control, but it comes at the cost of putting children’s health at tremendous risk. It also does not address the real problem the child is experiencing, which may be a lack of additional instructional help, poor nutrition, or an undiagnosed physical condition.
CCHR Colorado brought the policy omission to the attention of Brighton 27J officials early today. District chief legal officer Janet Wyatt reported that district Board policy was revised later in the day to bring it into compliance with state law.
The Brighton Standard Blade covered this story, which is available online to subscribers.

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News for Colorado

Denver Post Fails To Address The Role Of Psychiatric Drugs In Suicides

Psychiatric Drugs Are Linked To Worsening Depression and Suicide

A story in today’s Denver Post about suicides in Colorado failed to address a key issue:  How many of these individuals had been taking psychiatric drugs, known to worsen depression and increase the risk of suicide, before they took their own lives?

We know that individuals seeking help from psychiatrists will almost certainly be prescribed one or more psychotropic (mind-altering) drugs because, according to a recent article in the New York Times,drugging is so much faster and more profitable to the psychiatrists than taking the time to listen to their patients’ problems.

We also know that psychiatric drugs are known to cause serious, even life-threatening side effects.  (For international studies and warnings on the dangerous side effects of psychiatric drugs, as well as adverse drug reactions reported to the FDA, go to CCHR International’s psychiatric drug side effects search engine.)

Antidepressants in particular are known to cause worsening depression, birth defects, sexual dysfunction, anxiety, panic attacks, hostility, aggression, psychosis, violence, suicide and many, many other adverse events.  Long-term antidepressant users frequently report that their emotions have been deadened so much that they feel like zombies.

With drugging having become almost the only psychiatric “treatment” available, no wonder the rate of suicides in Colorado has shown no improvement whatsoever in the 22 years for which data is available from the Colorado Department of Public Health and Environment’s online death statistics database.

CCHR International’s award-winning documentary, “Dead Wrong: How Psychiatric Drugs Can Kill Your Child,” is the powerful story of one mother’s quest to understand her child’s suicide.  Six months after her son Matthew died, Celeste Steubing discovered the link between psychiatric drugs and suicide.  Feeling betrayed over having been denied these facts, she testified before the FDA in 2004, along with many other parents whose children had been driven to suicide by antidepressants.  That same year, the FDA issued its strongest, black-box warning that antidepressants can cause suicide, a warning that came 18 months too late for Matthew.  Click here to view the DVD and hear what parents, health experts, drug counselors and doctors have to say about the deadly dangers of psychiatric drugs.

If you have experienced increased depression, thoughts of suicide, or any other adverse side effect while taking a psychiatric drug, report it to the FDA by clicking here.

If you or someone you know has been harmed by psychiatric treatment or psychiatric drugs, you can contact us privately by clicking here or by calling 303-789-5225.  All information will be kept in the strictest confidence.  We also welcome your comments below.

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