It just means they haven't done enough clinical trials with younger people. Getting FDA approval for pediatric use is more difficult (as it should be).
Eating fish a few times a week won't lower your IQ, but if you're pregnant, the mercury content could leave your child permanently mentally disabled. Still-developing bodies and minds can be much more sensitive and delicate than an adult. Just because a drug has been shown to be safe and effective for adults doesn't mean it will be equally safe and effective for children.
Good question, first thing to note is for FDA approvals adult is generally defined as 17 years of age.
For the lack of pediatric indication, it's almost certainly because the clinical trials used 18-45 as the inclusion criteria. This is typically done as it is (expectedly) easier to get Institutional Review Board ethics approvals for adults and considerably easier to recruit patients both simply because it's easier to recruit adults as well as the relative prevalence of adult PPD patients.
I'm not a psychiatrist but the similar intravenous drug this is based on (brexanolone) is approved at ages 15 and over so I don't expect there is any reason this would be ineffective.
A general "stopping point" for human brain development tends to be around 25 years old, iirc. It wouldn't surprise me at all to learn that antidepressants might not function as well for teenagers- I certainly went through a fair few before going without any for a few years, and ending up on (and staying on) Lexapro when I was around 30.
Not disagreeing with your idea, but the age 25 thing is basically a myth. Different brain processes do continue developing into adulthood, but many finish developing younger while others never finish developing.
> When we spoke, I told Steinberg his work had been referenced in this way. “Oh no,” he said, laughing. I then asked whether he had insights about where the figure 25 came from, and he said roughly the same thing as Cohen: There’s consensus among neuroscientists that brain development continues into the 20s, but there’s far from any consensus about any specific age that defines the boundary between adolescence and adulthood. “I honestly don’t know why people picked 25,” he said. “It’s a nice-sounding number? It’s divisible by five?”
> Kate Mills, a developmental neuroscientist at the University of Oregon, was equally puzzled. “This is funny to me—I don’t know why 25,” Mills said. “We’re still not there with research to really say the brain is mature at 25, because we still don’t have a good indication of what maturity even looks like.”
Uh, if you're reading off table 1 at section 5.3, that's across all chronically-administered SSRIs -- not this drug in particular. Zurzuvae was evaluated in much smaller clinical trials of 347 women 18-44 and as far as I can tell, did not have any incidences of discontinuance due to suicidal ideation.
The suicide warning for AD is misleading. They don't _cause_ suicidal thoughts, but they can give you energy and the ability to function before they start lifting mood.
So if you're already suicidal, you can regain the ability to act on it before you get relief
That's not what the label warnings say. You're specifically contradicting the label's clear language, and you're saying that the FDA and the drug manufacturer are not telling us the truth when they put that label on a drug.
QED.
Furthermore, subjects with suicidal ideations or attempts are disqualified from clinical trials. In practice, this also means that any subject with depression is disqualified and shall not participate in any clinical trial for "antidepressants".
How does it feel to know that a drug that's supposed to treat depression, and may cause suicidal ideations and attempts, was never tested on anyone who was depressed?
I'm literally telling you word for word what my doctor told me, my guy.
Also, this rant is hilariously incorrect. You...do know that manufacturers continue to collect reports on side effects outside of clinical trials, right?
> That's not what the label warnings say. You're specifically contradicting the label's clear language, and you're saying that the FDA and the drug manufacturer are not telling us the truth when they put that label on a drug.
SSRIs and suicide risk remains controversial, habinero is describing one possible explanation and what I was taught in medical school over a decade ago. The label language is clear but you are failing to understand the complexity and rationale behind the warning and actual clinical implications. This is not unexpected as monographs are intended for a medical expert audience who are trained in their interpretation.
To keep it simple for everyone I suggest we defer to the Chair of the FDA proceedings that led to the boxed warning for his explanation as he is undoubtedly more of an expert than any of us on this matter (shortened for brevity):
It seems inconceivable that antidepressants would induce suicidality in the absence of other associated or antecedent behavioral changes. The essential message of the Black Box is to remind prescribers and consumers about the importance of monitoring closely for adverse behavioral changes during ... antidepressant therapy in order to reduce the risk of suicidality in patients through age 24 years. The intention was not to discourage appropriate prescribing of antidepressants for youth with depression, OCD or anxiety disorders.
In fact, some evidence .... suggested substantial reductions in antidepressant medication prescriptions in children and adolescents following the Black Box Warning ... For the majority of these patients, the benefits of antidepressants greatly outweigh the risks. Nevertheless, we agree ... that prescribers have a “duty to warn” and highlight the need for adequate training for all potential prescribers during medical school and residency programs.
I found these 2 pharmacotherapy RCTs on patients with suicidal ideation within 30 seconds of Googling.
> In practice, this also means that any subject with depression is disqualified and shall not participate in any clinical trial for "antidepressants".
> was never tested on anyone who was depressed?
How are you making this leap that none of the RCTs enrolled patients with depression? You do realize it's a minority that have suicidal ideation right?
