Fluoxetine, marketed under the brand names Prozac, Sarafem, Selfemra, and Rapiflux, is the only drug approved in the United States for depressed children aged 8 years and older, although the data used to obtain the approval are lacking. A reanalysis concluded that the drug was ineffective. Or safe.
Concerns about antidepressants should be discussed with your doctor. Those wishing to stop or reduce their dose are warned to do so only under medical supervision due to the risk of serious withdrawal symptoms.
The late psychiatrist and humanitarian Thomas Szasz, MD, co-founded the Civil Rights Commission to eradicate human rights abuses and restore human rights and dignity to the field of mental health.
Common antidepressants have no clinically relevant benefits for depressed children and teens, but they do pose safety risks, researchers argue.
— Peter C. Gøtzsche, MD, Director, Institute for Scientific Freedom, Denmark
WASHINGTON, DC, United States, Jan. 11, 2023/EINpresswire.com/ — Data Submitted to Drug Regulatory Authorities for Approval for Use of Antidepressant Fluoxetine in Depressed Children and Teenagers A review of the two researchers found the drug’s approval to be safe and effective for that age group.
Fluoxetine, the collective name for Prozac, Sarafem, Serphemra, and Lapiflux, is the only drug approved by the Food and Drug Administration (FDA) for depressed children 8 years and older in the United States. [1]
Researchers Peter C. Gøtzsche, MD (director of the Institute for Scientific Freedom, Denmark) and David Healy (psychopharmacologist and professor of psychiatry at McMaster University, Canada) used fluoxetine to gain approval. We conducted a systematic review of three clinical trials. A 2002 study of depressed children and adolescents in the United States.
A recent analysis published in the International Journal of Risk & Safety in Medicine found no clinically relevant benefits for fluoxetine. This was also the conclusion of patients who rated fluoxetine as ineffective. The researchers further found that the data showed that “suicidal ideation and suicidal behavior and aura of violence occurred more frequently with fluoxetine than with placebo.” [2]
Gøtzsche and Healy were critical of the two trials they investigated. They argued that key information was missing in the two studies and that there were “many errors, unexplained numerical discrepancies, and unexplained exclusion of patients from the analysis.” , “Results that contradicted the conclusion that fluoxetine was safe and effective were either sidelined or explained in disturbing ways,” they wrote.
In pointing out that the effects of antidepressants on growing children and adolescents are unknown, they refer to the fluoxetine package insert, stating that “the long-term effects of fluoxetine on growth and development cannot be directly evaluated. There is no research to do so,” he said. Maturity in pediatric and adolescent patients. “
According to their review, the researchers’ conclusions were straightforward.
Patients or parents who are concerned about new research are encouraged to discuss it with their physician. Also, be careful not to stop or change your medications unless under the supervision of your doctor, as there is a risk of serious withdrawal symptoms.
In 2006, approximately 3.3 million young people under the age of 25 were taking antidepressants. By 2020, that number has grown by more than 70% to over 5.6 million.
Youth suicide is on the rise in the country, along with the number of young people taking antidepressants. In 2006, a total of 4,408 of her children and adolescents under the age of 25 took their own lives, of which 219 died among her children under the age of 14. By 2019, the number of suicides he had increased by 47% to 6,500, of which 546 were by children under the age of 14, an increase of almost 150%.
The FDA first took action in 2004 against the increased risk of suicide from antidepressants, requiring the drug to have a black box label. Drug trials have found that children and adolescents are taking a new generation of antidepressants, selective serotonin reuptake inhibitors (SSRIs). In 2007, the FDA extended the warning to young adults between the ages of 18 and 24.
A recent study reconfirmed the effectiveness of black box warnings. Glen I. Spielmans, Ph.D., professor of psychology at Metropolitan State University in Minneapolis, led a study that analyzed data from clinical trials of antidepressants and found that black box warnings led to an increase in youth suicide due to low numbers of children. We investigated critics’ accusations that I was on medication.
“Recent data suggest that increased antidepressant prescriptions are associated with increased adolescent suicide attempts and suicide attempts among American children and adolescents,” the researchers concluded. I am writing in Frontiers of Psychiatry 2020. [3]
“Based on this body of evidence, regulatory warnings about antidepressant-related suicide are clearly justified,” they wrote, adding: of these risks. “
The main rationale for prescribing SSRI antidepressants to correct deficiencies in serotonin or other brain chemicals presumed to contribute to depression has been questioned by recent research. A review of reviews led by Joanna Moncrief, M.D., a psychiatrist and academic at University College London, finds scientific evidence supporting the theory that low levels of serotonin cause depression, even after decades of brain research. has yet to conclude.
“A comprehensive review of the main body of research on serotonin provides convincing evidence that depression is associated with, or caused by, low serotonin levels and activity. No evidence was shown,” the researchers wrote. “It also calls into question the rationale for the use of antidepressants.” [4]
The Citizens Commission on Human Rights (CCHR) continues to raise public awareness about the risks of serious side effects and withdrawal symptoms from antidepressants and other psychiatric medications. This allows consumers and their physicians to start or stop drug use in an informed manner. CCHR supports safe, science-based, drug-free approaches to mental health.
CCHR performs a complete physical examination including laboratory tests, nutritional and allergy screens, and all current medications to identify the physical cause of depression and other undesirable mental and emotional symptoms. Recommend review.
WARNING: Stopping or changing psychiatric medications should only be done under medical supervision as dangerous withdrawal symptoms may occur.
The Citizens Commission on Human Rights was co-founded in 1969 by members of the Church of Scientology and the late psychiatrist and humanitarian Thomas Saas, M.D., to end abuse and restore human rights and dignity. I was. To the field of mental health. CCHR has been instrumental in obtaining 228 laws prohibiting psychiatric abuse and human rights violations worldwide.
The CCHR Office of State in Washington, DC advocates for mental health rights and protections at the state and federal levels. CCHR’s traveling exhibit, which has toured 441 major cities around the world and educated more than 800,000 people on the to-date history of abusive and racist psychiatric practices, was held in Washington, D.C. Congressional Negro Caucus Foundation Annual Legislative Session and elsewhere.
[1] https://www.fda.gov/consumers/free-publications-women/depression-medicines
[2] https://www.scientificfreedom.dk/wp-content/uploads/2022/11/2022-Gotzsche-restoration-of-the-two-fluoxetine-trials-in-children.pdf
[3] https://pubmed.ncbi.nlm.nih.gov/32116839/
[4] https://pubmed.ncbi.nlm.nih.gov/35854107/
Anne Guedeke
Citizens Commission on Human Rights State Affairs Office
+1 202-349-9267
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CCHR: Antidepressant Warning
https://www.youtube.com/watch?v=GSfkwNmYesSQ
