Relevance
Antidepressants emerged on the consumer market in the mid-1950s. At the time, the American Food and Drug Administration (FDA) did not have any regulations in place for such drugs, and clinical trials were needed in order to prove that the drugs fulfilled their purpose and did so safely. The first of these drugs was iproniazid, upon which the standard for judging the suitability of antidepressants would come to be based.
Throughout the 1960s, 1970s, and 1980s, antidepressant regulation was nearly non-existent. Few new drugs had been developed in those decades, as the most popular forms of antidepressant medications remained monoamine-oxidase inhibitors (MAOIs) and tricyclic antidepressants (TCAs).
In 1990, an academic paper was published by Dr. Martin Teicher from the Harvard Medical School that suggested a possible link between the use of Prozac and suicidality. It was the point at which the FDA started to seriously consider the inherent risks of using antidepressants, some three years after Prozac had been made available to those who suffer from depression.
In 1991, the FDA received testimony from individuals and family members of those who claimed to be have been adversely affected by the drug and met with representatives of Prozac’s manufacturer, Eli Lilly and Company, to discuss conducting a new series of trials on the drugs. Lilly presented its findings to the FDA sometime thereafter, and the drugs were not found, at that time, to increase the risk of suicidality in users.
Throughout the 1990s and early 2000s, many law suits were launched against major drug manufacturers by family members of victims of suicide who were actively using antidepressants at the time of death, despite the fact that studies on antidepressants continually showed no increase in the risk of suicidality in any patients. However, more detailed studies would eventually focus on two groups: children and the elderly.
In 2004, the FDA’s Dr. Robert Temple raised concerns before the U.S. Senate about the risk of suicidality in children who use antidepressants, after conducting an intensive study that confirmed the claim, which resulted in a ruling that forced drug manufacturers to place a “black box” warning label on all antidepressant medications. It read, “Antidepressants increased the risk of suicidal thinking and behavior (suicidality) in short-term studies in children and adolescents with Major Depressive Disorder (MDD) and other psychiatric disorders. Anyone considering the use of [drug name] or any other antidepressant in a child or adolescent must balance this risk with the clinical need. Patients who are started on therapy should be observed closely for clinical worsening, suicidality, or unusual changes in behavior.”
More detailed information on the FDA’s actions between 2004 and 2006 regarding antidepressants can be found here. Other information and a comprehensive medication guide for antidepressants can be found here.
Mind
Throughout the 1960s, 1970s, and 1980s, antidepressant regulation was nearly non-existent. Few new drugs had been developed in those decades, as the most popular forms of antidepressant medications remained monoamine-oxidase inhibitors (MAOIs) and tricyclic antidepressants (TCAs).
In 1990, an academic paper was published by Dr. Martin Teicher from the Harvard Medical School that suggested a possible link between the use of Prozac and suicidality. It was the point at which the FDA started to seriously consider the inherent risks of using antidepressants, some three years after Prozac had been made available to those who suffer from depression.
In 1991, the FDA received testimony from individuals and family members of those who claimed to be have been adversely affected by the drug and met with representatives of Prozac’s manufacturer, Eli Lilly and Company, to discuss conducting a new series of trials on the drugs. Lilly presented its findings to the FDA sometime thereafter, and the drugs were not found, at that time, to increase the risk of suicidality in users.
Throughout the 1990s and early 2000s, many law suits were launched against major drug manufacturers by family members of victims of suicide who were actively using antidepressants at the time of death, despite the fact that studies on antidepressants continually showed no increase in the risk of suicidality in any patients. However, more detailed studies would eventually focus on two groups: children and the elderly.
In 2004, the FDA’s Dr. Robert Temple raised concerns before the U.S. Senate about the risk of suicidality in children who use antidepressants, after conducting an intensive study that confirmed the claim, which resulted in a ruling that forced drug manufacturers to place a “black box” warning label on all antidepressant medications. It read, “Antidepressants increased the risk of suicidal thinking and behavior (suicidality) in short-term studies in children and adolescents with Major Depressive Disorder (MDD) and other psychiatric disorders. Anyone considering the use of [drug name] or any other antidepressant in a child or adolescent must balance this risk with the clinical need. Patients who are started on therapy should be observed closely for clinical worsening, suicidality, or unusual changes in behavior.”
More detailed information on the FDA’s actions between 2004 and 2006 regarding antidepressants can be found here. Other information and a comprehensive medication guide for antidepressants can be found here.
Mind
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