# Alosetron In Men



## oldjoe (May 9, 2007)

I am a 69 year-old man. I have a lifetime history of IBS-D. I used alosetron when in came out in 2000. I found it effective, and I had no trouble from it. I had used it for about 6 months when it was pulled rom the market. I see it was re-introduced in 2002 but can only be presribed for women with IBS-D.I can't find out why this is limited to use in women only. Does anybody know where I can find the reason, and what would happen if men use it? I know that men have a lower absorbtion ability for the drug, but that's usually overcome by a larger dose.


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## Kathleen M. (Nov 16, 1999)

the first time around it was only approved for woman.The problem is that it doesn't seem to work for as many men as it does woman. Not enough of a difference to be statistically better than placebo for the group as a whole.If they can't prove it does anything in the population as a whole they can't get approval for it.I do not think it is any more dangerous for men and I think some men do get it (insurance coverage may be more difficult).There was one study that showed a very small percentage of men respond physiologically in the same way the woman it works for, so there is that. It just isn't something easy to test for.


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## oldjoe (May 9, 2007)

Kathleen,So, you don't know of any dangers in men? Is there any medical article or other reliable source of info that you know of re: effects in men?P.S. I am an old member of this BB, but forgot my old ID, etc., so have just re-joined. I think my old number was in the hunreds. I see you are still working on it. I thought with alosetron I was all set, and was very discouraged when it got pulled from the market. I have mostly used loperamide to help lately, with fair results.


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## Kathleen M. (Nov 16, 1999)

I assume it has the same risks that it has in woman (extreme constipation and ischemic colitis) I don't know if we have the data to support that, but I think it is safe to assume that one needs to watch for those problems in men who try it.Here is the study comparing men and womanhttp://www.ncbi.nlm.nih.gov/entrez/query.f...l=pubmed_docsum


> However, two females showed no slowing of colonic transit on treatment. Among male patients, two of 15 had a slowing of colonic transit at 24 h that was greater than the mean change in female patients, suggesting responsiveness to alosetron among a subgroup of males.


Here is a more recent study in men that showed some benefit, and did enough men you can see they get similar problems to woman.http://www.ncbi.nlm.nih.gov/entrez/query.f..._docsumB=pubmed


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## oldjoe (May 9, 2007)

Thanks. Those articles were just what I was looking for. I suspect that prescribing for men will soon become "legal" after the ladies have been used a guinea pigs to dispel the panic-like reaction that greeted the initial reports of alosetron side-effects. Obviously a safer drug is needed, but I hope in time other companies will venture back into this important area. Meantime, I guess it's bootleg alosetron time. Maybe we can get it in Mexico.


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## Kathleen M. (Nov 16, 1999)

I think some doctors will prescribe it "off label" for men. "Off Label" prescribing is not illegal.Insurance may not cover it, but I think some men here have had a doctor that will prescribe it.I'm not sure I'd trust bootleg Lotronex.


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## 21723 (Aug 19, 2005)

From what Ive read don't expect Lotronex to be approved for men. It would cost GSK millions to get it approved and they would not see a return on their investment. Only a hand full of men take it now and it really does not work as well on us.I am on my second week of .5mg bid and seeing little improvement, certainly not worth the $350 it cost me for a one month supply. I am going to try 1mg bid and see how that works. My ins co says I am not covered because I am a male. If the drug works I will deal with the ins co with a discrimination lawsuit. Drugs are prescribed all the time off label and the ins co's pay for it. I'll keep you posted on my progress.


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## echris (Jul 19, 2000)

I'm a 66 year old male. I have taken Lotronex since it came on the market, during the time that it was off the market and continued since it has been back on the market. When it came back on the market, my insurance carrier initially rejected my claim but, when I appealed it, they agreed to cover it. For a long time, I was taking two of the 1.0 mg tablets a day. The last couple of months, I have been able to reduce it to 1/2 of a 1.0 mg tablet every other day. It is quite expensive. My last refill, for 3 months, cost my insurance company over $600. The nicest thing about the Lotronex is that, after over 25 years with chronic D, I am finally actually seeing a reduction in my anxiety about eating. I now routinely have meals without having to run to the bathroom during the meal which is really nice.Don't want anyone to get their hopes up too much about any single drug being a miracle. I have also been on a gluten free diet for several years now. Absent the gluten free diet, nothing really controlled my D.


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