The FDA Announces Two More Antacid Recalls Due to Cancer Risk
wired.com
wired.com
I don’t think the penalty for not storing your medicine quite right should be ingesting a carcinogen.
I also think it's unlikely that those people who are keeping their meds in their car are also keeping their meds dissolved in a solution with high levels of nitrite.
Still, this suggests that ranitidine may not be stable and its breakdown products may be risky. If mixing it with nitrite produces NDMA under condition found in the stomach that is another risk case. I wonder if there is any breakdown over time just sitting on the shelf?
And yet even pharmacies have no problem shipping via consumer services in the dead of summer, and show zero care for whether "overnight" actually means "over weekend".
One time I was on a drug that had to be shipped to me from an out of town pharmacy in a refrigerated vehicle. The delivery guy demanded that my apartment leasing office refrigerate it, which led to them almost losing it.
Next time I had it shipped to a local pharmacy instead for pickup. That pharmacy didn’t refrigerate it at all and insisted that was kosher. (They also almost lost it.)
I called the original pharmacy and they assured me it doesn’t actually need to be refrigerated, as long as it doesn’t reach its melting pint of like 100 F.
The package said it needed to be refrigerated.
If you call the company, they can basically answer any question you ask, even for un-approved indications.
But for them to bring it up without you asking is a big Nono.
For all day-to-day drugs it's really a precaution rather than anything else. Usually they just become a little less effective by becoming less concentrated, but most of the ones I worked with even the 50/80(?) ones were still fine years later (stored at 50 degrees celsius, 80% humidity (I think? Was 20 years ago)). We had a special warm room where all the samples were kept.
https://www.nakedcapitalism.com/2020/01/big-pharma-wont-let-...
It’s not just Zantac. It’s blood pressure medication and now diabetes 2 medication to lower blood glucose. If you read the Bloomberg article linked in the post, it’s even more scary. Basically they don’t test the drugs which is why They are being discovered one by one.
If you’re on any sort of generic medication, it’s probably manufactured in India/China and it’s probably contaminated. And if it’s not contaminated it might not even fit to specifications, ie too much of the drug or too little per pill. It’s happening all the time and the FDA is reactive not proactive. There’s a quote in the Bloomberg article about a judge not wanting to peel the onion because it could be too bad.
Valisure said “these levels are too high”, the FDA came back with “you’re testing it wrong”, so the FDA retested and determined a few of the drugs has higher than allowed NDMA, but we’re talking 10-50% too high (of a very small limit), not the 20,000% too high that Valisure claimed.
My guess is the FDA will institute new guidelines on testing, manufacturers will change their processes and ranitidine will come back in a year or so.
The first step in the synthesis of ranitidine is a Mannich reaction on a furan compound (furfuryl alcohol) to produce essentially one half of the molecule. The key reagent in that step is dimethylamine hydrochloride.
The final steps of the synthesis involve conditions that will form nitrosamines from amines.
Thus, if any dimethylamine hydrochloride is left over after the first step, conditions exist to turn it into NDMA.
Dimethylamine is a bugger to get out of a reaction mixture, and it would not surprise me to find that a poorly-designed or badly executed reaction scheme may fail to remove some trace amounts, therefore opening the door to producing NDMA. In other words, as an impurity existing from the first step of the synthesis.
So it's not just a case of "NDMA accumulation".
I have had experience witnessing syntheses of pharmaceutical APIs at Indian manufacturing plants, and have seen some horror stories.
The NYT reports that Sanofi's recall "applied only to the United States and Canada, and that its products sold outside the two countries were sourced from different suppliers", which is fairly common practice. So it may be that only some API makers have the problem, which is likely a manufacturing and QC problem.
There are somatic processes, likely starting in the stomach and concluding in the liver, which are efficiently converting ranitidine to NDMA. Here's just one study. https://academic.oup.com/carcin/article/37/6/625/1744630
Did they get in a spat with suppliers? Are they trying to dump the price of ranitidine and nizatidine to buy up at markedly reduced value? Perhaps drive down demand from drugs with less margins towards higher ones?
For those downvoting: this is business as usual in entrenched markets like pharmaceuticals -- especially since the FDA has no capacity to enforce anything.
And on more thorough review, it looks like the hysteria has spread to many other countries as well -- how quaint.
For those that really aren't aware of what good hysteria marketing looks like, please take a look at: https://www.valisure.com/blog/uncategorized/detection-of-ndm...
Anyone that works in the world of marketing/PR can see it plainly.
I don't feel like digging into what strings they had to pull in order to get this viral, but anyone possessed by curiosity should take a look at their team: https://www.valisure.com/about-us/ After reading their profiles, two members should instantly pop out at you.
Jirstrand is runner-up from all the impressive PR work she's done.
Berkal: very weak maybe.
They did NOT simulate a normal diet with common levels of sodium nitrate. At 10 mM there is no NDMA found. Sodium nitrate concentrations for meat are much lower than 10 mM. The FDA puts a strict upper limit of sodium nitrate concentrations in meat at 100mg/kg, so around a concentration of .015mM (!)
I don't need to do any further math to tell you no one is eating that much cured meat in a single sitting (it's simply not possible).
Edit: sibling comment provides some evidence that the concentrations of nitrites where they observed NDMA are much higher than what might be expected in a normal diet.
It’s debatable how effective antacids are anyway; for example, if you have an H. Pylori infection, antibiotics would be way more effective.
That suggests that you have a gallbladder dysfunction. You might want to get an ultrasound for gallstones.
This URL doesn't load in my version of Firefox (old and heavily tweaked, I admit). And it crashes Midori.
But this works fine:
$ w3m -dump https://www.wired.com/story/the-fda-announces-two-more-antac...
Edit: OK, it works in my Firefox if I hit escape as soon as the page has loaded. So maybe there's some non-content module that loads more slowly, and triggers the problem. It could be a "turn off ad blocker" popup. Given that I block popups.
Meanwhile, Grandma can read the article just fine when she double clicks on the blue e.
I have no problems with maybe 90% of sites. So I'm pretty confident that the rest are doing something odd, and likely not in my best interest.
Some cool sites do require WebGL, which I block. But I can't imagine that's needed to display text and images. And I can even handle NYT's trippy images layout.
I really have no clue what some sites are doing, however. It could be ad blocking, or the fact that I'm using a German VPN exit. Or maybe one or both of those plus blocking popups. Maybe referrer and/or fingerprint obfuscation.
But it's easier to find workarounds for that ~10% than figure out just exactly how they're breaking basic HTML and CSS.
(Side note: My kids' grandma is a retired software developer. So I guess maybe it's just that the average grandma is more sophisticated than we are?)
Folks, this is not a good sign.
I mean, there are laws against stalking, right?
Are you in the EU?
You are blocking ads, I presume?
Do you see any popups?
Blocking ads, blocking js, EU. Firefox on Android.
Additionally, my traffic and dns go through a (also EU hosted) DO droplet which is running pihole and dnscrypt.