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Lotronex, FDA Approval, and Men...

347 Views 11 Replies 4 Participants Last post by  JeanG
G
In reading several of the posts about the recent GW press releases and approval of Lotronex/Alosetron by the FDA, I'm getting confused about what that approval means for men.Specifically, the wording of the FDA approval (as displayed in these posts) ranges from "We don't RECOMMEND it for men" to "We don't APPROVE it for prescribing to men" to "Physicians CANNOT prescribe it for men". The admonitions seem to range from a benign caution up to an outright prohibition.Can someone DEFINITIVELY clear this up for me?? Is it NOT approved for use in men, and does that translate to an actual prohibition??If I ask my doctor to prescribe it for me because I want to try it, am I going to be asking him to break the law, or just go against a benign FDA recommendation?? Obviously, I don't want to ask a doc to break the law, but I would certainly discuss the possibilities with him if it was just a matter of insufficient data on male studies coupled with a soft FDA recommendation.Thanks...BJ
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My two Dr's (Family & Gas..) both told me in person this week that they would give me a prescription for this drug when I'm finished with the study. I think this drug gives me about 80% releave. I have only had D onetime in about 3 weeks and no real painful attacks at all. The only problem for me in getting this drug will be the dose I need it could be that I may require more than the 1mg that they are going to produce in the being....
A doctor can prescribe it for any sex they feel it will help.1) female2) male3) hermaphrodite3) pseudo-hermaphrodite, including transsexuals.4) genders invented by those claiming abduction by space aliens.
G
I liked that flux!
I think that a man taking Lotronex is the same as a woman taking Viagra.It might work or it might not work. Noone Knows for sure!
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G
Bob,Once a drug is approved, physicians can prescribe it for conditions/genders the drug was not originally approved for. For example, the antidepressant Trazodone is sometimes prescribed to treat insomnia, because of its sedating properties.
G
flux, bobk, poly, and Guy - thanks very much for the answers.And flux...my compliments on your wit. In fact, since I was abducted by space aliens while fishing at night in a Mississippi swamp with my cousin Billy Bob Rae, it certainly seems like I would be eligible for a Lotronex prescription. And, of course, I can afford it since I sold the rights to my story to the National Enquirer.BJ
Not only that, Bob, but a little bird told me that they will not only specify that it is for women only. They just have to get through retesting the men. Chuckle, chuckle, Flux![This message has been edited by Persistance (edited 02-13-2000).]
G
I just read a thing on the internet about Lotronex. First, it is not recommended for men because it doesn't seem to work. Second, the main side effect is constipation which i definitely don't need. Matt
Good one, Flux!!
JeanG------------------I'm also Praying with Bettie for a cure for this NASTY IBS! ANDMay the "farce" be with you. JeanG
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G
Good one, flux .... but what about me??
Julie
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Judamar:From this point onward we shall be known as, The Advance Guard for the Ozone Rangers!
Don't worry, they have something out there for all of us!!!
JeanG------------------I'm also Praying with Bettie for a cure for this NASTY IBS! ANDMay the "farce" be with you. JeanG
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Hi Guy:I didn't see your post on trazadone. I do take it for insomnia. It does enable me to get at least some sleep. Sleeping pills don't do a thing for me.JeanG------------------I'm also Praying with Bettie for a cure for this NASTY IBS! ANDMay the "farce" be with you. JeanG
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