FDA expands black-box warning on antidepressants

Black Box Warning

Muy importante:

“A Food and Drug Administration advisory panel on Wednesday agreed with the agency’s proposal that the labels on antidepressants should be expanded to include the risk of increasing suicidal thoughts and behaviors in young adults.”

This FDA expansion ruling is significant because it expands the black-box warning from children and adolescents (up to 18 years old) to young adults (up to 25 years old). However, what about the gap between those 25-34 years old? And then 34-65 years old? Studies consistently show that teens and the elderly are at the highest risk for suicide attempts. Why isn’t there also a black-box warning for those 65 and older?

My recommendation? The FDA needs to slap a general black-box warning on all antidepressants saying that it “can increase the risk of suicidal thoughts and behaviors.” Period.


“Adult antidepressant studies carried out by pharmaceutical companies suggest that adults up to age 24 are more than twice as likely to think about or try suicide if they’re using antidepressants than if they’re taking sugar pills. The studies didn’t find that antidepressants increase suicidal behavior for adults ages 25 to 64, and the drugs appear to reduce suicide attempts in patients 65 and older.” – USAToday

Interesting conclusion considering the statistics above. I’m skeptical. Thanks to PsychCentral for pointing this out.


“These are a brief list of comorbid conditions that occur with depression. If any of these problems are untreated, the SSRI can often amplify the depression and the impulsivity. More likely to suicide.

1. Bipolar illness
3. Temporal lobe dysregulation following brain injury
4. Metabolic issues including bowel, liver, and hormonal dysregulations
5. Other meds not properly identified as interacting and creating toxic reactions
6. Improperly adjusted dosage
7. Sleep not addressed simultaneously
8. Nutrition insufficiency: effects biotransformation and  foundation of neurotransmitters
9. Neurotoxins already present
10. Genetic inability to metabolize different SSRIs, causing toxic accumulation”

Thank you, CorePsych, for pointing out what often gets overlooked.

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