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absorption of Miralax

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I finally looked at some of the FDA files that posted the link to...found this one especially interesting for absorption issues:http://www.fda.gov/cder/foi/nda/99/020698a_MiraLax_clinphrmr.pdf

Scroll down to the end, and you can see charts relating to how much PEG (Miralax) was excreted. Look at the column labeled, " PEG recovery. " Whatever wasn't recovered, I presume, either stayed in the body or was excreted later, after they stopped checking. It seems to vary between 0 and 5%. In these adults. Of whom only a handful are listed in these charts.

I was bemused to see, in some of the other documents, that many of the patients on whom PEG was tested were living in nursing homes. They were told to keep a diary of their constipation-related symptoms while taking PEG. But...what if they had other complications? It seems like those were defined as not being PEG-related. Not that they couldn't have been caused by PEG...in some ways I think the whole issue was muddied because these patients were in nursing homes because they already had a variety of medical problems. I can see why the researchers opted to use elderly patients, because they often struggle with constipation, but...I still don't think this was a good study. I was kind of appalled that this is what the FDA considers good medical research. It's not that it was bad per se, it's just that the research focus was so narrow...I'm concerned that they could have missed the forest for the trees, so to speak. I mean, if elderly patients on PEG developed urinary problems, or neurological issues, it would just be chalked up to age. The researchers weren't particularly looking for those issues and wouldn't be likely (in my nonscientist opinion) to have detected them if they did crop up.

Bonnie

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