FDA Orders Black Box Warnings on Antidepressants labels and Patient Information Guides to Warn about Suicide risk
Fri, 15 Oct 2004
We have won the first battle in a struggle for full disclose of serious adverse drug effects and disclosure of failed clinical trials.
Prescribing physicians and the public have an urgent need and a right to know. Not until Congressional committees and the Attorney General of New York entered the fray, and examined a body of concealed evidence, did FDA officials "see the light."
From now on, parents will be informed that a causal relationship has been found between suicidal behavior and antidepressant drugs. They will, for the first time, be able to make an informed decision affecting their children’s health and lives.
For more than 15 years drug companies, the psychiatric establishment – including the American Psychliatric Association, the National Institute of Mental Health – and the FDA denied the link between antidepressants and increased suicide.
But the evidence from controlled clinical trials and post-marketing case reports is overwhelming: children and adolescents who were prescribed an antidepressant were twice as likely to become suicidal compared to those given a placebo. Furthermore, the drugs showed no clinically significan benefit beyone placebo.
News reports rarely disclosed that leading psychiatrists who are cited as "experts" have significant financial ties to the manufacturers of these drugs, and might therefore have a conflict of interest. Is it unreasonable to suspect that their steadfast defense of the drugs’ efficacy and safety might be even slightly influenced by their financial ties?
But journalists continue to be beguiled by speculative scientific hypotheticals which psychiatrists discuss as though they have been proven. Misinformation is transmitted to the public about unproven "chemical imbalances" in the brain of depressed people – when, in fact, NO EVIDENCE EXISTS demonstrating any chemical or structural brain abnormality in people diagnosed with a mental illness.
Indeed, no psychiatric diagnosis – for adults or children–has attained the scientific standard of a demonstrable medical disease. Psychiatry has only identified symptoms which may have any number of causes – some drug-induced, others due to a physiological disease. Thus, psychiatry’s authoritative (though flawed) diagnostic reference tool – the DSM IV – refers only to "disorders" not disease.
Although the focus, thus far, has centered on the suicide risk for children under 18, FDA’s warning for antidepressants applies to adults and children. Evidence exists demonstrating a suicide link to these drugs in adults as well.
A front page article in today’s Wall Street Journal refers to "decades of nueuroscience wisdom" then proceeds to transmit yet another round of speculative hypotheticals about children’s brains, promoted – without validation–by "expert" psychiatrists whose institutions are dependent on antidepressant drug company funding.
"A growing number of studies suggest that the antidepressants called SSRIs stimulate the birth of new neurons in the brain. Boosting this “neurogenesis” might have different effects on a developing brain than a mature one.
Adult brains, according to decades of neuroscience wisdom, weren’t supposed to be able to make new neurons. But in a 2003 paper, molecular psychiatrist Ronald Duman of Yale and his colleagues showed that, in lab animals, antidepressants boost neurogenesis in parts of the brain.
The birth of new neurons takes time. Newborn neurons take weeks to travel to their target. Scientists now believe that this explains why SSRIs take weeks to affect depression.
The creation of new neurons in the brain had been assumed to be beneficial. In depressed adults, the hippocampus — the part of the brain responsible for learning, memory and emotion — is typically shrunken. By restoring it to full size, and presumably, full health, depression might be lifted. But in young people with depression, the hippocampus isn’t shrunken. It may be that the influx of new neurons is somehow detrimental to adolescents. Some scientists wonder whether the new neurons could destabilize fragile brain circuits in kids suffering from mental illness."
See: THE WALL STREET JOURNAL. Why Depression Looks Different In a Kid’s Brain, By SHARON BEGLEY
New Studies May Help Explain Links Between Suicide And Antidepressant Use The Role of Impulse Control
October 15, 2004; Page A1
Vera Hassner Sharav
FDA Orders Strong Antidepressant Warnings
13 minutes ago
By DIEDTRA HENDERSON, AP Science Writer
WASHINGTON – All antidepressants must carry a “black box” warning, the government’s strongest safety alert, linking the drugs to increased suicidal thoughts and behavior among children and teens taking them, the Food and Drug Administration said Friday.
Because the warnings are primarily seen by doctors, the agency also is creating an information guide for patients to advise them of the risk.
“Today’s actions represent FDA’s conclusions about the increased risk of suicidal thoughts and the necessary actions for physicians prescribing these antidepressant drugs and for the children and adolescents taking them,” said Dr. Lester Crawford, acting FDA commissioner.
The drug labels also include details of pediatric studies which, thus far, have pointed to Prozac as the safest antidepressant for youths to take.
On average, 2 percent to 3 percent of children taking antidepressants have increased suicidal thoughts, independent experts, working with Columbia University, found.
The FDA announcement follows to the letter guidance from federal advisers. After searing and emotional public hearings one month ago, the advisers urged the agency to add its most strident warnings to the drugs.
The FDA said in a statement that it recognizes that depression in pediatric patients “can have significant consequences in pediatric patients if not appropriately treated. The new warning language recognizes this need but advises close monitoring of patients as a way of managing the risk of suicidality.”
An information guide will be distributed with each antidepressant prescription. Parents will be advised to look for warning signs in children that include worsening depression, agitation, irritability, and unusual changes in behavior. Those worrisome signs could come within the first months of starting an antidepressant or when the drug’s doses changes – higher or lower.
In 24 trials involving more than 4,400 patients taking antidepressants, researchers found a greater risk of increased suicidal thoughts and behavior during the first few months of treatment.
Celexa, Prozac and Zoloft posed lower risks for children, researchers found, while Luvox, Effexor and Paxil had higher risks of increased suicidal thoughts and behavior.
Prozac is the only antidepressant approved by the FDA for use for treating depression in pediatric patients.
Anafranil, Prozac, Luvox and Zoloft have been used for treating obsessive compulsive disorder in pediatric patients.
The new warnings, however, will be carried by all antidepressants, including Anafranil, Aventyl, Celexa, Cymbalta, Desyrel, Effexor, Elavil, Lexapro, Limbitrol, Ludiomil, Luvox, Marplan, Nardil, Norpramin, Pamelor, Parnate, Paxil, Pexeva, Prozac, Remeron, Sarafem, Serzone, Sinequan, Surmontil, Symbyax,Tofranil, Tofranil-PM, Triavil, Vivactil, Wellbutrin, Zoloft and Zyban.
The agency’s action comes at a time when it faces withering criticism for not acting sooner on antidepressants, and for the shortage of flu vaccine and the high-profile withdrawal of Vioxx for safety concerns.
Congressional investigations have focused on allegations the agency silenced its own employees who tried to raise safety concerns on the antidepressants and Vioxx.
Copyright © 2004 The Associated Press. All rights reserved.
Webmaster’s note: As of 2 PM, 10/15/04, the above AP article has been slightly revised. The current version of this article is available at:
In the revised version, paragraphs three and four have been replaced by the following:
Dr. Lester Crawford, acting FDA commissioner, said the agency sought to balance the increased risk of suicidal thoughts and behavior against the known benefit of treating depression in children.
He said the new labels warn of the “risk of suicidality and encourages prescribers to balance this risk with clinical need.”
Prozac is the only antidepressant approved for use in children.
The following has also been added:
To make sure the medication guide is available with each prescription or refill, Crawford said the FDA would work with manufacturers to develop “unit of sale” packaging for all antidepressants. In “unit of sale” packaging, a medication is distributed in its original container and pre-labeled by the manufacturer. It contains sufficient medication for one normal course of therapy.