Archive for the ‘Xifaxan’ Category

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The etymology of an orphan

February 26, 2010

Xifaxan and its manufacturer, Salix, has been making news all week. An FDA advisory panel recently recommended the approval of Xifaxan in 550 mg tablets, as an Orphan Drug  for the maintenance of remission of hepatic encephalopathy (HE,) a dangerous result of liver failure.

Xifaxan or Rifaximin, is almost always the front line antibiotic used to eradicate SIBO. According to the literature, it has many advantages over other antibiotics. As a broad-spectrum, non-absorbable antibiotic, it is not absorbed into the bloodstream and it acts against both gram-positive and gram-negative pathogens. In many trials, the administration of Rifaxamin has produced a very low occurrence of side effects and additionally the risk of antibiotic resistance is lower with Rifaxamin than with many other antibiotics. Probably the most unique property of Rifaxamin, and also what makes it most useful to people with SIBO, is its demonstrated efficacy against bloating!  It has also been used to reduce or eliminate cutaneous lesions in Rosacea patients with SIBO.

To be honest I am unclear of the FDA’s recommendation for people with SIBO. If there is an impact, what does the drug’s status as an orphan drug mean for SIBO?

According to Wikipedia, the Orphan Drug Act is “meant to encourage pharmaceutical companies to develop drugs for diseases that have a small market.” That is certainly SIBO!  However, orphan drugs have to treat orphan diseases; conditions that affect fewer than 200,000 people in the United States. I have no idea how many people in the United States suffer from SIBO. During holidays and office birthday parties when I watch everyone eat candy I feel like I may be the only SIBO patient in the nation.

It may not matter whether or not SIBO is an orphan disease. Just a day before the news broke of the FDA recommendation, an article discussing the deliberation noted that Salix is planning to submit a new drug application for Xifaxan this year, specifically for the irritable bowel syndrome indication in the first half of 2010.

 Currently, Xifaxan is prescribed to people with SIBO off-label. The developments of Salix’s new application for Xifaxan for IBS will be of some interest to the SIBO community because if it is approved then Xifaxan could be prescribed specifically for SIBO. Xifaxan has not worked for all of us; I have taken several courses and sometimes it works and sometimes it doesn’t. However, the largest issue with Xifaxan for SIBO is the prohibitively high cost. Most insurance companies just don’t cover drugs when they are used off-label. If Salix’s application is approved, more people with SIBO will at least be able to try Xifaxan. Which, I believe is a good thing. It is interesting to note that there were questions of both efficacy and safety during the HE study, and the SIBO community should be on the lookout to see if these same issues arise during the IBS studies.

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All of the above most likely

November 17, 2009

Does this picture make me tear up (and sob uncontrollably) because

A) I grew up without a mother, who died when I was 10?

B) I’m afraid I’ll never have a child of my own? This used to be totally okay; I even went through the trouble of falling in love with a man who also didn’t want to have kids. I think if I were experiencing anything like what most women go through with their biological clocks I might have died by now, but mine’s ticking a little – I swear I can hear it under a pile of new wave CDs, my undying love for my cats, about 12 months of backlogged student loan payments, several layers of guilt about not being productive enough at work, a few screenplays I never wrote or produced, and that decision I have to make aboutwhat I’m going to wear this weekend to that party that I love.

C) I’m on my 6th round of Xifaxan and they always make me feel a little crazy?

OK Here are my symptoms: Slight irritability. A light feeling of sadness and despair. Light bloating and crampiness.

That’s it. Seriously.

And here’s my theory. Kefir ruined my life. This happened because the housekeeper wave is screwed, and has been since the spring of 2006, if not before. Kefir grains may be full of beneficial bacteria but they tend to deposit all the good stuff in all the wrong places for me. Hence, the last course I took of Xifaxan wasn’t able to help me as much as it normally does. Not because it wasn’t working, but rather because it was working so intensely hard. It was trying to get to the normal bad guys colonizing my small intestine, but it got really busy killing off an entirely new population of friendlies, kefir-y goodness friendlies, meant for my colon, which had taken up residence in my small bowel. This is why I had a CRAZY Herxheimer, which included severe body aches, depression, bloating and distention, headaches, diarrhea, and just loads and loads of misery. But it was all worth it because I got better, right?

WRONG! I pretty much felt only slightly better than before. Which is why I am taking a sixth course. I hold out hope that this time I truly did just need more Xifaxan to completely wipe out the unusually large (even by my dense standards) microbial zoo living in my short gut.

Good things that are happening – I’ve lost a few pounds, finally. I am slightly less tired than before and able to work out (which is why the weight is coming off – god bless you low carb enthusiasts like Taubes but if I don’t move I don’t lose) and I don’t want to spend my entire life under the covers, just some of it.

More to come.

Comments, suggestions?

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back on the xifaxan

October 15, 2009

1600 mg/day for 7 days. Each script for this stuff is a plane ticket to an exotic location I’m afraid I’ll never see.  Back on the ketogenic diet too.

Definitely at a low point. Feeling sick – bloating, body aches, brain fog. Spending a lot of time alone as I don’t feel well enough to go out as much as normal and my husband is working on a campaign. The weight is out of control. My body is still doing bizarre things and I get scared that I will never have a streak of good weeks/months again.

I’ve internet stalked some folks who I thought might have some good insight for the blog and the yahoo group and I’ve been ignored. I can’t blame them because its odd to be contacted privately and out of the blue but I would never turn someone down who asked for information like that. I wrote to Dr. Pimental with some questions on recurrance and I haven’t heard back; no surprise there. I’ve contacted some RDs in the area and what I’m hearing back about their knowledge of SIBO isn’t good news. Internet research turns up a lot of the same old forum posts/journal articles and even more dishearteningly, my own writings.

Then again, some things are going well. We have a new member in the Yahoo group and some enlightening discussions have been sparked. We’re possibly on the prowl for a doctor type that would hang out online and serve in an advisory capacity. I also managed to turn up a new-ish piece of research…for the second time. Its funny how bad brain fog can be. I posted the latest work of Dr. Pimentel (from June of this year) to the group back in August. Which means I obviously read it myself. However, it was all new to me when I reread it and found that he’s now recommending 50 mg of Erythromycin in a pediatric suspension as maintenance after antibiotic treatment for SIBO. Due to its pro-kinetic properties, E-mycin extended the time between symptom recurrence from 50 to 146 days. So I faxed the report to my doctor and I’ll be taking E-mycin after the Xifaxan.

And due to some of these enlightening discussions I just mentioned…I’m going to continue this yogurt/kefir fast. Its scary but after a gazillion recurrances with mere weeks in between, it cannot hurt.

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The antimicrobial properties of kefir, Gulf War Syndrome and gut bacteria, and the effects of high-fat nutrition on gut flora

September 2, 2009

Some interesting and unexpected research finds today:

On kefir, which I am beginning to make in my home

Resoution of Recurrent Clostridium difficile-associated Diarrhea Using Staggered Antibiotic Withdrawal and Kefir

Antimicrobial and healing activity of kefir and kefiran extract

And a few interesting studies recruiting now…

Bacterial Overgrowth Associated With Chronic Multisymptom Illness Complex
Taking the super obvious connection between SIBO and CFS past the obvious and examining the symptoms occurring specifically in Gulf War Syndrome (GWS) patients! Phenomenal!
And…

A controlled feeding experiment

“The purpose of this study is to determine the effect of dietary fat, in standard formulation, on the composition of the human microbiome in a prospective study of normal volunteers. Participants will be randomly assigned to either a high fat or low fat diet for 10 days. The gut microbiome will be phylotyped in fecal samples as well as in bacteria adherent to the colonic mucosa prior to, and during the course of the dietary interventions.”

I’m definitely going to want to follow these two for outcomes.