3 ms·
> Of all the things that seem wrong with solving this with a pill Is this based on any experience (clinical or research) in postpartum depression or some philo
by haldujai 3y ago
> Of all the things that seem wrong with solving this with a pill
Is this based on any experience (clinical or research) in postpartum depression or some philosophical objection?
In case you were unaware of what severe postpartum depression can look like:
Severely ill patients often report suicidal ideation and behavior, typically demonstrate obvious impairment of functioning, and often manifest poor judgement that places the patient and others (including children) at risk for imminent harm. In addition, patients are more likely to develop complications such as psychotic and catatonic features and have a history of severe or recurrent episodes. Patients with severe major depression should be referred to a psychiatrist for management and often require hospitalization.
Source: UpToDate
> Is the FDA immune from suits if this results in a generation of damaged kids?
Sued for what? It's clearly stated in the drug monograph.
Available data from a clinical lactation study in 14 women indicate that zuranolone is present in low levels in human milk (see Data). There are no data on the effects of zuranolone on a breastfed infant and limited data on the effects on milk production.
The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for ZURZUVAE and any potential adverse effects on the breastfed child from ZURZUVAE or from the underlying maternal condition.
https://documents.sage-biogen.com/us/zurzuvae/pi.pdf https://documents.sage-biogen.com/us/zurzuvae/pi.pdf
> We should compare the kids"?
All patients enrolled in the trial were asked to stop breastfeeding. It is unethical to perform the study you are suggesting and even if it were no IRB would approve per regulations.
https://www.hhs.gov/ohrp/regulations-and-policy/regulations/45-cfr-46/common-rule-subpart-d/index.html https://www.hhs.gov/ohrp/regulations-and-policy/regulations/...