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us food and drug administration: 3627t2c

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sg9- 1 2 3 4 5 6 7 8 9 . 10 11 12 13 14 15 16 17 . 18 19 20 21 22 . 23 24 25 201 TWO of t he other cases were very, very complicated -- the lady with multiple adhesions. So, I think we should not be counting all these patients indiscriminately as complications of constipation. DR. HANAUER: Thank you. Yes, Dr. Siegel? DR. SIEGEL: I don't know if I am getting this point correctly, but to me', I don't think it matters too nuch whether all of those patients were specifically related :o the drug in a causal factor. I think that, especially >nce it becomes a little bit looser in terms of the prescribing, it is important to have some sort of a >enchmark so that we can see that when patients who aren't necessarily the perfect patients for these drugs are receiving it, whether we can see, you know, how constipation ind those serious complications change when those kind of xactice patterns are established. DR. HANAUER: Yes? MR. HAMMES: Obviously, the rate of serious zomplications that we are seeing enough were enough to set )ff some flags. I would like to think that the efforts of :oday are going to decrease that rate. So, I would say -et's start where we are and monitor it, and if it goes up irom here we have a real problem, and it should go down. DR. HANAUER: Any other goals that the committee rould like to address? MILLER REPORTING COMPANY, INC. 735 geh Street, S.E. Washington, D.C. 20003 (202) 546-6666

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