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Re: Nepal develops more effective drug for typhoid - 18-07-2007, 10:44 PM

Well, I believe it is the most effective and cheap medicine available todate. I say this becuase that's what the data says and I was primarily invovled in treating the patients.

There are several clarifications I want to make about the issues that have come up in this forum.

First of all we should read and be updated and verify what we have heard from other sources. It reminds me of good old saying of "Kag le kan lagyo vandai ma kan ko pachadi dau dunu hudai "

The drug is not banned in the US!!! And FDA still continues to approve it. They haven't withdrawn it. Only the Bristol Myer Siquib, a patent right company withdrew its sale only from North American market because of fear of litigations. That's being hysteric.Once agian, what ever treatment modalities US doctors follow is not appropriate all the time.

What ever side effects of hypo and hyperglycemia reported so far were primarily in the patients with diabetes. We didn't have any patient with diabetes enrolled in our study. We gave Gatifloxacin to 390 patients and none of them had any serious side effects. As every knows so called dangerous hypo/hyperglycemia would warrant these patients to be admitted in the hospital because they become so sick. None of the patients became sick requiring admission rather those on gati improved quicker and better. Only complications we had was in cefixime group.

Well what ever discussion we doing right now is largely based on the retrospective audit of prescriptions in elderly patients whose mean age group 78 years(NEJM, march 2006). They had diabetes and were on oral hypoglycemic agents also. Really can't draw any definite conclusions from that study. We need prospective double blind study to answe this questions.
There are association of dysglycemia with gatifloxacin and association is different from causation. One should give us convincing evidence that gati causes dysglycemia.

Trails are stopped early due to various reasons. One being if a drug is found to be very very effective than other compared drug. Then the trial is stopped in the middle because the difference in out come was so huge that you dont' need to reach the target sample size to have statistically significant results

I anyone need to read or know about gati an FDA, I would suggest you all to do some homework on gati. Read March 2006 NEJM article, go to FDA website and what really FDA says about it. It doesn't say don't use gati. Even with cipro and oflox DDA gives warning of cartilage toxicity, how many of us don't use cipro/oflox in children. FDA hasn't approved any flouroquinolones below 18 years of age. Now does it mean that we are poisoning our kids here in nepal because we are prescribing flouroquinolones in pediatrics as well as in young adults who are between 13 and 18 years of age !!! Did u guys get what I mean?
Being the first author of the article, I would end my discussion saying that I would take gatifloxacin if I get typhoid. I would treat my brothers, father and mother with gatifloxacin if they get typhoid and don't have diabetes.

Anil Pandit, MD
Maryland General Hospital
University of Maryland Medical System
Baltimore, Maryland.
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