Postpartum depression: new drug will be monitored at approved sitesBMJ 2019; 364 doi: https://doi.org/10.1136/bmj.l1400 (Published 26 March 2019) Cite this as: BMJ 2019;364:l1400
- Owen Dyer
The first drug approved by the US Food and Drug Administration for the treatment for postpartum depression will be administered only to short term inpatients at specially approved sites, as the FDA seeks to monitor risks of adverse events that emerged during clinical trials.1
Brexanolone (made by Sage Therapeutics and marketed as Zulresso), is an injected drug that has shown a much faster effect than oral treatments in ameliorating depressive symptoms, but the demands of infusion—and the risk identified in trials of patients fainting or having reduced consciousness—mean that patients will have to remain at designated treatment centres for 60 hours while the drug is infused.
Any adverse events will be carefully tracked as part of a risk evaluation and …