“Black Box” FDA Warnings for Antidepressant Medications
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Despite perceived safety and popularity of SSRIs and other antidepressants, studies suggest usage can bring dangerous and understated side effects, especially for adolescents and young adults. In 2004, after a thorough review of data, the Food and Drug Administration (FDA) adopted a “black box” warning label on all antidepressant medications to alert the public for potential risks of increased suicidal thoughts in children and adolescents taking antidepressants. In 2007, the agency extended the warning to include young adults up to age 25. A “black box” warning is the most serious type of warning on prescription drug labeling. The warning emphasizes that children, adolescents and young adults taking antidepressants should be closely monitored, especially during the initial weeks of treatment, for any worsening depression, suicidal thinking or behavior, or any unusual changes in behavior such as sleeplessness, agitation, or withdrawal from normal social situations. These FDA approved medications have never been tested on children or approved by the FDA for adolescents. The FDA concludes these medications were not originally “designed” for adolescent use, which makes it sound as if prescription medications are actually “designed” for anyone. They are not, they are concocted extracts, synthetically modified to attack, address or alter various areas of the mind and body. Quite often prescription medications, especially those where patents are about to expire, are reassigned or relabeled to address other illnesses or symptoms, which may be completely unrelated to the original disorders or symptoms they were tested and approved for. This means, more often than not, the relabeling of these powerful medications is a marketing ploy, to ensure highly profitable patents do not become lost revenue streams. Medications That May Contribute to Pediatric Suicide
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