5 ms·
What black box warning are you talking about? The only one I see for Zurzuvae is: "IMPAIRED ABILITY TO DRIVE OR ENGAGE IN OTHER POTENTIALLY HAZARDOUS ACTIVITIE
by haldujai 3y ago
What black box warning are you talking about?
The only one I see for Zurzuvae is: "IMPAIRED ABILITY TO DRIVE OR ENGAGE IN
OTHER POTENTIALLY HAZARDOUS ACTIVITIES"[1]
[1]https://documents.sage-biogen.com/us/zurzuvae/pi.pdf https://documents.sage-biogen.com/us/zurzuvae/pi.pdf
- caeril 3y agoI haven't yet read the clinical trial results, but suicidal ideation has turned out to be a shockingly common side-effect of many other types of anti-depressants. The comment was unnecessarily inflammatory, but the concern is reasonable.
- NoZebra120vClip 3y agoMy bad - not a black box in this case. Just a regular box. Sorry for the confusion.
- haldujai 3y agoBlack box (obsolete) and regular box are the same thing, they're simply called boxed warnings. In case you think this is semantics, boxed warnings are a determination by the FDA of a risk of adverse reaction so serious in proportion to the benefit of the drug it must be considered when assessing risks and benefits. The warning you are referring to is a regular warning which is used when there some evidence of a causal association but a causal relationship has not been definitively identified. In this specific instance it is based on an association of increased suicidality in a study looking at all antidepressants for all depressive indications and specifically in patients below the age of 25, not specific to this drug or drug class. This warning is accordingly present on all antidepressants. I won't go into the knowledge base behind this warning, its magnitude and variation between drugs but it is readily available online. Suffice it to say medical experts do not view the risk serious enough to merit a boxed warning and should the FDA have wanted to absolve themselves of blame as. you suggest it would be boxed.