Blackbox warnings are on medications for a very good reason, but the FDA would like this one removed.
Stay informed and alert so that you do not get misled by these tactics
The Black Box Warning Label is on Antidepressants For a Very Good Reason
Yet health professionals would like to see it removed
The title of this Medscape post (FDA antidepressant warnings tied to increase in suicidality) had me thinking that the FDA was giving out a warning that antidepressant drugs could lead to suicidal and homicidal ideation, so I read the article.
As soon as I started reading it, I realized I completely misunderstood the article heading.
The article author, Brooks, did acknowledge that these antidepressant drugs have had a black-box warning label since 2005, indicating that these drugs can increase the user's risk of suicide for those younger than 18 years old. That black box warning label was updated in 2007 to change the age to 24.
However, the article was about reevaluating that black box warning and a possible replacement (removal?).
Why, you would wonder, if a drug that is “supposed” to improve your mood but could also make it worse to the point of suicide, would the FDA/drug manufacturers consider removing a label that warns the user of this potentially deadly occurrence?
The author claims, based on a study, that once the warning label was put in place, there was less antidepressant use. The argument is that people did not use the drugs out of fear of the risk of suicidal tendencies and thus did not get proper treatment. The author further argues that this meant an increase in suicides.
To assume that the rise in suicides is related solely to a black box warning is absurd.
My argument here is: where is the longitudinal evidence that these drugs will improve mood? Where is the proof that depression is due to a lack of serotonin when we have Systematic reviews that indicate this belief is false?
Do you think that Prozac is going to give you an endless supply of serotonin? (Some patients do believe this because what an SSRI drug does has never been explained to them by their medical professional).
If parents and young adults are avoiding antidepressants due to the suicidal risk, are the practitioners offering other solutions? From my experience, the only other option they offer is talk therapy, which in some instances may be helpful but certainly not for all cases.
The mindset that a drug is the only solution for depression is a harmful one but one that continues.
The STAR-D Trial
Dr. McFillin did an excellent interview with Robert Whitaker (founder of Mad in America) in which they described the faults of the STAR-D trial, which has been considered the gold standard for antidepressant efficacy. (The discussion of the STAR-D trial begins at 34:58).
The STAR-D trial was not placebo-controlled, so we do not know how many people would have seen remission in one year without any drug intervention. Additionally, the study did not compare drug use to any other modality, so we do not know if any alternative option would have yielded positive outcomes.
For entry into the study, participants had to score 14 on the HAM-D (Hamilton Depression Rating Scale ). A score of 14 to 17 is considered mild to moderate depression. A score of greater than 17 is considered moderate to severe depression.
The depressed individual in the study starts on citalopram, and if that were not effective, meaning your score was 7 or above on the HAM-D, they would try a different drug on you. If you did score below 7, you were seen as in remission and placed into the one-year follow-up study.
If each drug was not effective, then the person got placed on another medication.
The study concluded that medical professionals need to keep trying different medications to find which one is effective for that person.
The study concluded there was a 70% cure rate…
However, Whitaker states that out of 4,040 people in the study, 1,508 fell into the remission category, and of those people, only 108 were still well and in the trial at the end of one year.
That means, in actuality, only 3% stayed well at the one-year mark.
At 45:23, Whitaker mentions the TAD study. He also states that it is a corrupt study in children in which 17 of the 18 suicide attempts were people on Prozac (fluoxetine), even though that is not what was reported, as they concluded there was no excess risk in the drug group. Whitaker goes on to mention that the side effects of psychosis and mania can be worse in kids.
As I write this, another school shooting,
this time in Wisconsin.
I read somewhere in the past that a pharmaceutical rep is on site after a school shooting; however, I do not know where I read that and cannot find a source in a search.
But while looking, I did find this:
A December 2010 study by Moore et al. concluded that 1527 cases of violence were reported in which only 31 drugs were the suspected cause. Of those 31, 11 were antidepressants, 6 were sedative/hypnotics, and 3 were drugs for ADHD. Therefore, acts of violence may be associated with only a small select group of drugs.
I also came upon a letter from Matt Powell that was written to the Connecticut governor regarding a firearms bill (in response to shootings). Powell wrote that the focus instead should be on the relationship between mass shootings and prescription drugs.
In Powell’s letter (I do not know when it was written), he provides a long list of suicides and homicides and the drugs these people were taking. He also lists others for whom we do not have medication information.
Going back to the Medscape article
A commenter on the Medscape article page stated that the study author has a long advocate history for increasing antidepressant use, and a person quoted in this Medscape article (McIntyre) has also received speaker fees from many drug companies.
Why This Matters
When the doctors wanted to put our son on an antidepressant at 15 years old, not one medical professional (and we saw many) noted this very deadly risk. I was instead only informed that he may experience a cotton mouth.
Seriously, that was it. That information came from the psychologist. The prescribing psychiatrist did not tell me one side effect of the drug!
What if I am a parent who completely trusts the doctor and wholeheartedly believes in allopathic medicine, and that black box warning label is removed?
Bottom Line
Black box warnings are there for a good reason and must stay.
Allopathic doctors need to be made aware of options for depression that are out of their scope and refer their patients instead, not just to psychiatrists and psychologists but to professionals such as nutritionists who specialize in endogenous root causes of depression.
The deception needs to stop, such as cherry-picking studies so that antidepressant drugs appear effective or basing the drug's effectiveness long-term on studies that last only 8 weeks.
Furthermore, in the drug trials, were the depressed participants in the placebo group told to stop their current antidepressant medication abruptly, and if so, did they consider the harmful side effects of sudden withdrawal? How does this impact the study results?
Additionally, many people are placed on an antidepressant off-label for other issues, such as not being able to fall asleep or stress at work. Many people who lost their loved ones while they were taking an antidepressant will tell you they were not even depressed, that the doctor put them on the drug for an entirely different reason, yet they committed suicide.
And yet, there is still no accountability for all these tragic deaths.
Do you think it will get any better under the MAHA agenda?
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I think the real problem is much deeper than black box warnings. For a long time, I have thought that all of these anti-depressants should be removed from the market. They don't work. Like you said, "only 3% stayed well at the one-year mark." It is my suspicion that this 3% would have stayed well at the one-year mark with a placebo. Prove me wrong.
The only thing they serve is the allopathic model where every "disease" can be treated with a pill. They make treatment easier for the parents because just giving a pill is easier than long investigation into alternative therapies that do work. These therapies include dietary changes, magnesium supplementation, bolstering support structures, and more.
Unbekoming has a great article today on magnesium:
39. How does magnesium deficiency relate to stress, anxiety, depression, and violent behavior?
Magnesium deficiency is closely linked to stress, anxiety, and depression. Magnesium plays a crucial role in regulating neurotransmitters involved in mood and emotional stability. When magnesium levels are low, the nervous system becomes more sensitive to stress, leading to heightened anxiety and increased risk of depression.
Magnesium deficiency can also contribute to violent behavior. Studies have shown a correlation between low magnesium levels and aggressive behavior, potentially due to the mineral's role in regulating neurotransmitters and calming the nervous system. Additionally, the calming and mood-stabilizing effects of magnesium have been observed in clinical settings, further supporting its role in mental and emotional well-being.
40. What evidence supports the use of magnesium in improving mental and emotional health?
The NIH's recognition of depression as a sign of magnesium deficiency in 2000 provides substantial support for the mineral's role in mental health. Numerous studies have demonstrated magnesium's efficacy in reducing anxiety and improving mood. Research also indicates that magnesium supplementation can alleviate symptoms of depression and even prevent its development.
Clinical experience further supports the use of magnesium for mental and emotional well-being. Healthcare professionals, including those specializing in mental health, have observed significant improvements in patients with anxiety and depression after supplementing with magnesium. The testimonies of individuals who experienced relief from mental distress after magnesium supplementation provide additional anecdotal evidence of its positive effects.
https://unbekoming.substack.com/p/transdermal-magnesium-therapy