Zelnorm- for girls only?

Why is Zelnorm- (pills you take for IBS) limited to women only? :confused:

Men have IBS too, right?

Your Dr. can write you a script for Zelnorm, and you’ll get it.

I think you’re talking about coverage, which is the amount your insurance pays.

Men might have IBS, but it’s far more common for women to have it.

What was your question?

The ads only show women, and say it’s for women, and same with Consumer reorts in this months issue. They don’t say why. :confused:

I only posted this question a month ago.

(BTW, my favorite is the brunette with the blue shirt. ROWR!!)

I almost posted this question a month ago. :smack:

from www.zelnorm.com (where else)

Can men take Zelnorm?
Zelnorm is a medicine for the short-term treatment of women who have Irritable Bowel Syndrome (IBS) with constipation as their main bowel problem. Zelnorm does not work for all women who use it. The safety and effectiveness of Zelnorm in men have not been established.
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Why can men not take Zelnorm?
Zelnorm received FDA approval based on the results of two clinical studies, each lasting 12 weeks in duration. Both studies involved primarily women patients.
e.g. it is not licenced for men!

Doesn’t Zelnorm sound like a wonderful name for a comic book villain?
“You will bow down before Zelnorm, Jor-el! And after you, your heirs! Or else I’ll make their guts miserable!”

So it sounds like because most of the sufferers are women they conducted their clinical trials in women, and therefore the drug is only approved for use in women. Would it work for men? Probably, but they need to prove to the FDA it is also safe and effective for men before they can market it.

I can tell you that it can be difficult to get enough volunteers for a statistically significant clinical trial for a drug that treats a disease or condition that disproportionately affects one gender more than the other. The company I work for has run into the same thing in reverse…we have a drug for a disease that affects males far more than females. The clinical trial for males was relatively easy and was completed quickly but the one for females started much later because of the difficulty in finding eligible patients.

So there’s probably no known reason why men couldn’t take it, it’s just that it hasn’t been established that they can? Does that mean in a few years it’ll probably end up being prescribed for both men and women?

Because if they had guys hiking up their shirts so you could read the writing on them, it would be weird, rather than a catchy new style of advertising. Like those singing bellybutton commercials, which weren’t weird at all. :rolleyes:

I was prescribed Zenorm for my stomach problems. It didn’t help, but they did prescribe it and dispense it. (I’m male by the way.)

I like men’s bellies . . .

[nitpick]“e.g.” means “for example”[/nitpick].

The real question is why isn’t it approved for men? Why didn’t they study it in men? Is it specifically contraindicated?

I suspect it’s as Laughing Lagomorph posted about - too hard to get sufficient male candidates as it’s far more common in women, and they most likely preferred to see if it was effective at all as soon as possible. It’d be like testing breast cancer drugs on men, for instance - men get breast cancer but lots less frequently than women. Plus, women get IBS symptoms more frequently/strongly during their menstrual period, so it’s possible the clinical trials were limited to women to try to account for that variation.

It used to be common for drug trials to be done only on men (unless it was for “female problems”) because women’s menstrual/hormonal cycles were thought to be possible confounding variables. But then the drugs would get prescribed for women without much thought on testing.

ouch I hate being nitpicked, but you are quite right. “id est” it should have been.

There are some safety concerns about zelnorm in rare instances
http://www.hc-sc.gc.ca/hpfb-dgpsa/tpd-dpt/zelnorm_hpc_e.html