Why is hydrotalcite not available in the USA?
February 22, 2021 1:51 PM Subscribe
On a 2019 trip to Germany, my wife found antacids that really, really work for her. Since then, we've been importing rather marked-up packages from the Balkans. Is there a good reason why Bayer sells hydrotalcite everywhere but here in the USA?
We didn't bring antacids to Germany, and an extremely helpful Apotheke clerk set her up with a packet of Talcid. They're great! But every package is finite, and stateside we ended up on eBay getting identical tablets, with very similar branding, but with all the box text in Slovak. Looking around for this same thing, I see that this exact same product seems to be available as "Talcid" throughout most of central Europe, "Rupurut" in much of the Balkans, "Rennieliquo" in France, "Талцид" in the Cyrillic-alphabet-using world, "达喜" in China... but I come up blank trying to find this product (made by Bayer or anyone else) in the US. Is there a good reason why it's impossible to find hydrotalcite antacids in America?
We didn't bring antacids to Germany, and an extremely helpful Apotheke clerk set her up with a packet of Talcid. They're great! But every package is finite, and stateside we ended up on eBay getting identical tablets, with very similar branding, but with all the box text in Slovak. Looking around for this same thing, I see that this exact same product seems to be available as "Talcid" throughout most of central Europe, "Rupurut" in much of the Balkans, "Rennieliquo" in France, "Талцид" in the Cyrillic-alphabet-using world, "达喜" in China... but I come up blank trying to find this product (made by Bayer or anyone else) in the US. Is there a good reason why it's impossible to find hydrotalcite antacids in America?
Key phase in the US when it comes to stuff under the FDA's purview is "generally recognized as safe and effective". It takes lots and lots of money and time to get the FDA to approve something (or, to get your Senator to push legislation to remove something from that purview all together, like Sen. Orrin Hatch did with supplements and "natural" products.
Bayer already makes a jillion dollars with Alka Seltzer. Perhaps they figure that proving that hydrotalcite is also both safe and effective isn't going to be worth the cost it would take to get it approved by the FDA.
posted by sideshow at 2:21 PM on February 22, 2021
Bayer already makes a jillion dollars with Alka Seltzer. Perhaps they figure that proving that hydrotalcite is also both safe and effective isn't going to be worth the cost it would take to get it approved by the FDA.
posted by sideshow at 2:21 PM on February 22, 2021
For what it's worth, hydrotalcite appears to be chemically similar—though not identical—to the active ingredients in Extra Strength Gaviscon. I'm a little rusty on my chemistry, but both contain magnesium, aluminum, hydroxide, and carbonate groups; the difference seems to be in their relative proportions and arrangement in the "dry" crystal structure. It might be worth a shot. (Regular Strength Gaviscon is chemically different.)
posted by Johnny Assay at 2:43 PM on February 22, 2021 [4 favorites]
posted by Johnny Assay at 2:43 PM on February 22, 2021 [4 favorites]
I'm not a chemist or pharmacist but here's some information that might help:
According to drugs.com, alternate names involve some form of the words "aluminium magnesium hydroxide carbonate hydrate". The same page also lists various commercial names it's known as, and to your point, the US is not on it.
The FDA list of approved antacids does seem to refer to it (Sec. 331.11(2))?
posted by Candleman at 3:04 PM on February 22, 2021
According to drugs.com, alternate names involve some form of the words "aluminium magnesium hydroxide carbonate hydrate". The same page also lists various commercial names it's known as, and to your point, the US is not on it.
The FDA list of approved antacids does seem to refer to it (Sec. 331.11(2))?
posted by Candleman at 3:04 PM on February 22, 2021
I'll just add to Johnny Assay's information that cheaper store brands equivalent to Extra Strength Gaviscon are available at Rite-Aid and CVS, at least.
posted by JimN2TAW at 3:05 PM on February 22, 2021
posted by JimN2TAW at 3:05 PM on February 22, 2021
This thread is closed to new comments.
The Ask MeFi answer for Ambroxol at the time was that the patent has expired so it's now a generic drug. If the safety studies are too old it's not worth the time and money for a company to get it through a new FDA approval only to have it be immediately produced by everyone else.
I'd look to see if hydrotalcite is in the same situation.
posted by JoeZydeco at 2:20 PM on February 22, 2021 [1 favorite]