Yep. Just happened to see this [1] article out of the corner of my eye while browsing. Really concerning. And from the sound of it, this Valisure place, not the FDA, is the one who discovered the issue. One wonders what use regulators are these days.
My infant daughter was prescribed ranitidine for reflux from age 3 months to about age 6 months. Anyone with more chemistry knowledge than me want to venture any guesses about how concerned I should be?
Do you have any of the pills left? You could get the leftovers tested. But I would ask your pediatrician. I would guess you probably don't need to be specifically concerned.
Yeah, I replied to another commenter, but I have some of the syrup left over and I'm sending it to be tested. Turns out the folks who discovered this have publicly-available testing. I'm thinking that the limited duration is a good thing. Fingers crossed.
It's a different issue than the valsarten issue. Valisure is suggesting that ranitidine breaks down itself into NDMA, which, as an organic chemist, I guess could happen to a small degree based on the structure[1], but it would be hard to mimic the conditions inside the body in a lab.
The Valisure petition speculated that the source of the NDMA was the result of the “inherent instability” of the ranitidine molecule, which can degrade under certain conditions, such as when it is digested, to create NDMA.
From the NDMA wiki: [NDMA] is also used to create cancer in rats for cancer research.
That is super alarming.