Yet sadly it is still on the market. Is there a number of deaths that are enough?
There is also this small 2016 study:
"Interference with neuronal development
Pregnancy outcome following maternal exposure to pregabalin may call for concern
ABSTRACT
Objective: To investigate pregnancy outcomes following maternal use of pregabalin.
Methods: This multicenter, observational prospective cohort study compared pregnancy outcomes in women exposed to pregabalin with those of matched controls (not exposed to any medications known to be teratogenic or to any antiepileptic drugs). Teratology Information Services systematically collected data between 2004 and 2013.
Results: Data were collected from 164 exposed pregnancies and 656 controls. A significantly higher major birth defect rate in the pregabalin group was observed after exclusion of chromosomal aberration syndromes, and when cases with exposure during first trimester of pregnancy were analyzed separately (7/116 [6.0%] vs 12/580 [2.1%]; odds ratio 3.0, 95% confidence interval 1.2–7.9, p = 0.03). The rate of live births was lower in the pregabalin group (71.9% vs 85.2%, p < 0.001), primarily due to a higher rate of both elective (9.8% vs 5.0%, p = 0.02) and medically indicated (5.5% vs 1.8%, p = 0.008) pregnancy terminations. In the Cox proportional cause specific hazards model, pregabalin exposure was not associated with a significantly higher risk of spontaneous abortion.
Conclusions: This study demonstrated a signal for increased risk of major birth defects after first trimester exposure to pregabalin. However, several limitations such as the small sample size, differences across groups in maternal conditions, and concomitant medication exposure exclude definitive conclusions, so these results call for confirmation through independent studies."
In theory, LLMs could review more sources for a personalized risk assessment. But a brief query on this subject yielded generic responses from multiple LLMs :(
I've seen AI recommended things like Fluoroquinolones (Avalox, Cipro, Levaquin etc), for UTIs.
The FDA itself says this class of drugs work no better than a placebo for UTIs, Sinusitis and Bronchitis. While they cause life altering side effects. They 'Flox' people.
My late wife's Journal was part of the evidence during a 2015 FDA hearing to get this crap off the market.
The bottom line is that AI can not be trusted for Medical Advice.
Be highly suspicious of a Human doctor recommending a drug in this class, that has so many Black Box Warnings.
There is also this small 2016 study:
"Interference with neuronal development
Pregnancy outcome following maternal exposure to pregabalin may call for concern
ABSTRACT
Objective: To investigate pregnancy outcomes following maternal use of pregabalin.
Methods: This multicenter, observational prospective cohort study compared pregnancy outcomes in women exposed to pregabalin with those of matched controls (not exposed to any medications known to be teratogenic or to any antiepileptic drugs). Teratology Information Services systematically collected data between 2004 and 2013.
Results: Data were collected from 164 exposed pregnancies and 656 controls. A significantly higher major birth defect rate in the pregabalin group was observed after exclusion of chromosomal aberration syndromes, and when cases with exposure during first trimester of pregnancy were analyzed separately (7/116 [6.0%] vs 12/580 [2.1%]; odds ratio 3.0, 95% confidence interval 1.2–7.9, p = 0.03). The rate of live births was lower in the pregabalin group (71.9% vs 85.2%, p < 0.001), primarily due to a higher rate of both elective (9.8% vs 5.0%, p = 0.02) and medically indicated (5.5% vs 1.8%, p = 0.008) pregnancy terminations. In the Cox proportional cause specific hazards model, pregabalin exposure was not associated with a significantly higher risk of spontaneous abortion.
Conclusions: This study demonstrated a signal for increased risk of major birth defects after first trimester exposure to pregabalin. However, several limitations such as the small sample size, differences across groups in maternal conditions, and concomitant medication exposure exclude definitive conclusions, so these results call for confirmation through independent studies."
Still on the market...Why?
https://web.archive.org/web/20161029080541/https://www.neuro...