Yes I've seen this before. It comes out of the US approved prescribing information for doctors and this type of detailed information about almost every possible risk you'll find with many pharmaceuticals. Go to US where you can advertise prescription drugs on TV, they always finish off the ad with a long disclaimer about every possible side effect. Personally I think some people are going a bit overboard on this. The pregnancy issue came about from animal data it says, it doesn't prove that sparsentan will have this problem in humans but regulators are rightly cautious and insist the potential human risk is included here. It's not uncommon to see this sort of thing especially when a new drug hits the market. Travere has stated recently they expect the REMS conditions to be removed at some stage. You also need to look at what the actual patient data from their trials showed.
You've heard of the drug aspirin? I'm guessing you've taken it at some time? You know it's been around for about 150 years?
Now check this out:
https://www.bayer.com/sites/default/files/2020-11/aspirin-pm-en.pdfIt's the full product information from Bayer the manufacturer. It runs to 59 pages! The warnings and precautions section alone is over 4 pages.
DXB200 may well be "safer" than sparsentan and not have such warnings if and when it is launched, but it would be very unwise to draw hard and fast conclusions at this time, you never know that some serious problem could emerge with DXB200 when more information comes from more patients and used for longer.
(20min delay)