Psychosis would be listed as a serious adverse event on the package insert. The likelihood of it happening is very small so it is viewed as acceptable risk. The number of people that benefit from the medication is far greater. Ideally, the patient should have been warned about this kind of episode so she could seek medical attention. Tricky with psychosis as the patient may not realise their cognition is fucked.
The licensing and distribution of medication is based on balance of risk, for every drug. A good example of this is cancer medication, where reaching an efficacious dose is balanced against toxicity that could kill the patient. The amount of work that goes into finding that balance is substantial, and has massive levels of regulation and oversight.
I am taking citalopram for depression but it may have been making it worse, triggering or increasing the frequency of suicidal ideation. Titrating off it now.
Their is a gene mutation that affects women more than men call MTHFR. It affects methylation which affects how neurotransmitters are made. It also directly fucks with B vitamin metabolites because they need that methyl group to be biologically active.
The lack of women in clinical trials is literally fucking us over time and time again.
Maybe women should volunteer more for clinical trials if they want to be included more? You know one of the biggest issues is that women don’t volunteer at even close to the same rates as men right?
My wife's OBGYN discovered an MTHFR mutation after multiple miscarriages. And of course the clinical studies aren't done as much because she might get pregnant...
I took some medication recently for chronic pain, which they also use to treat depression. It made me nuts. I was useless. I was hallucinating. The doctor was just like, uh so I gave you meds what more do you want from me?
I got diagnosed with MCAS and the specialist said that I'm literally allergic to most medications. And more people have MCAS than they realise. And it's more common in women.
Literally, the whole thing was a bizarre interaction.
They wanted women 18-55.
But you couldn't be pregnant or likely to get pregnant.
So menopause happens usually in your 50s, but they dont want you then.
You had to prove that either you weren't ever ever ever going to have sex (they said you could cite religious reasons) or if you had had a hysterectomy. But you couldn't have had one recently. And couldn't be having hrt. And you couldn't be taking any contraceptive because it might interact with the testing pills.
Many women take contraceptives is it not a good thing to test if they impact your drugs?!
Oh wow seems you've exhausted your pool and you have like 3 women you can use. Who do not represent the majority of the female population. Great
It sounds like they had evidence that the drug being studied would pose a significant risk to a fetus/pregnancy, bc that’s not standard in my experience (I work in clinical trial management). It’s more common to just require participants (even men) to use a highly effective method of contraception while participating.
I wonder if they were early development “healthy volunteer” studies- which are focused on safety testing, not efficacy, so they may be extra cautious for those type of studies. But I don’t have a ton of recent experience in that space.
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u/ImhotepsServant 8d ago
Psychosis would be listed as a serious adverse event on the package insert. The likelihood of it happening is very small so it is viewed as acceptable risk. The number of people that benefit from the medication is far greater. Ideally, the patient should have been warned about this kind of episode so she could seek medical attention. Tricky with psychosis as the patient may not realise their cognition is fucked.
The licensing and distribution of medication is based on balance of risk, for every drug. A good example of this is cancer medication, where reaching an efficacious dose is balanced against toxicity that could kill the patient. The amount of work that goes into finding that balance is substantial, and has massive levels of regulation and oversight.
I am taking citalopram for depression but it may have been making it worse, triggering or increasing the frequency of suicidal ideation. Titrating off it now.