What happened to Kaopectate's old formula?
August 2, 2005 7:31 AM   Subscribe

What does "nonmonograph designation" mean, with regards to pharmaceuticals and the FDA? Or, more specifically, why did the FDA pull attapulgite off the market?

As best I can determine, antidiarrheals which used attapulgite (such as the old formula of Kaopectate) were pulled off the market or reformulated after the FDA, in 2003, gave it "nonmonograph designation." I'm curious as to what a "nonmonograph designation" by the FDA is, and what the background story is behind attapulgite specifically being yanked.

Kaopectate now works off of the same active ingredient as Pepto-Bismol, and when I tried to find out why Kaopectate was reformulated, and what other medications might have attapulgite, I ran across the FDA stuff that said attapulgite wasn't available, period, anymore.

This may be one of those obscure ones no one can answer, but then again, I got nearly everything wrong with Chapi Chapo, and you guys still got me an answer ... :-)
posted by WCityMike to Health & Fitness (5 answers total)
This FDA statement suggests that attapulgite was dinged because the FDA wasn't satisfied that it was effective for the indication it was being advertised for.

If your drug requires FDA approval, you can't just, for instance, bottle up some water and say it cures cancer. You have to have evidence that it does so.
The FDA found attapulgite efficacy data to be inadequate and, thus, attapulgite was not included as a monograph ingredient in the April 17, 2003 final rule.
posted by ikkyu2 at 7:41 AM on August 2, 2005

"nonmonograph" means "not safe for human use", "insufficiant data" or "the label is making false claims".

Attapulgite, calcium polycarbophil, and polycarbophil have been reclassified from proposed category I to nonmonograph status because of insufficient effectiveness data.

posted by cmonkey at 7:42 AM on August 2, 2005

Here is yet another doc on attapulgite. Look for the section titled "III. Summary of Significant Changes From the Proposed Rule", it describes what was wrong with all the studies. Mostly lack of placebo controls, it seems.
posted by smackfu at 7:45 AM on August 2, 2005

This link (click here instead for its enclosing frame) explains where the 'monograph' comes in in the FDA regulatory process. Basically it's an approved chunk of text describing the drug and its properties and the evidence for those properties; these monographs get collected, edited slightly, and reformatted in books like the PDR.
posted by ikkyu2 at 7:46 AM on August 2, 2005

Wow. Thanks, everyone ...
posted by WCityMike at 7:53 AM on August 2, 2005

« Older Upgrading a Vaio's PSU & GPU   |   Where should we move? Newer »
This thread is closed to new comments.