# FDA Approves Restricted Marketing of Lotronex



## Kathleen M. (Nov 16, 1999)

http://www.fda.gov/bbs/topics/NEWS/2002/NEW00814.html K.


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## Kathleen M. (Nov 16, 1999)

Glaxo's press release http://www.gsk.com/press_archive/press_06072002.htm K.


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## Stace (Sep 20, 2000)

I do not suffer with D, but am so thrilled for those who need Lotronex! Wonderful news!!Stacey


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## LotronexLover (Jan 10, 2001)

I didn't call myself LotronexLover for nothin' LOL


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## JeanG (Oct 20, 1999)

This is fantastic news!!! Jeff was quoted in the New York Times at: http://www.nytimes.com/aponline/health/AP-Bowel-Drug.html You have to register to read the article, but you are not sent junk mail, nor information sold.JeanG


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## Jeffrey Roberts (Apr 15, 1987)

Additional information on Lotronex, including the revised professional and patient labels and physician and patient agreement documents, can be found on FDA's website at: http://www.fda.gov/cder/drug/infopage/lotronex/lotronex.htm


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## echris (Jul 19, 2000)

I, too, am pleased to see Lotronex back on the market. Congrats to all those people on and off of this BB, especially Jeff, who put in so much work to help so many people.Now every IBS - D patient and their doctor can at least consider this important medication. Hopefully it will no longer be prescribed to individuals who already have problems with constipation.Now watch Concerned Citizen go to work to identify anyone with the remotest condition that they can relate to the medication. They have made it perfectly clear that they aren't done with Lotronex.echris


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## trbell (Nov 1, 2000)

check ABC news tonighttom


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## knothappy (Jul 31, 1999)

When can we get our hands on it?? Like maybe tomorrow??????


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## *Luna* (Nov 19, 2001)

YAAAAAAAAAAAAAAAAAAYYYYYYYYYYYYYYYY!!!!!!!!!!!!!!!!!!!!!!!!!!!My heart jumped for joy when I saw the press release!!!Now I have to hope for the first time that my IBS can be considered "severe." I've definitely had "severe" bouts but do manage it better now. Altho I do have my days when it really does limit my activities, it's not as frequent as it used to be. Of course, if I didn't watch what I ate, I could easily be a severe case real fast.Hopefully a dr. will take pity on me and consider me severe enough!! Lotronex changed my life so much when I was taking it!!!A thought... I wonder if patients will lie (or exaggerate) to their dr. about how severe their symptoms are so they can get Lotronex??


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## MarkinCA (Mar 23, 2000)

Congratulations, women. I envy you.Men are completely out of luck.Has there been even a hint of considering allowing men to get it?Mark


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## Jeffrey Roberts (Apr 15, 1987)

The good thing about the medical system is that once acredited withyour doctorate you are privileged to practice medicine anyway youchoose. This is called the "art of medicine".Given that men were receiving Lotronex off-label from the beginning,there is nothing in this new restricted marketing that says men cannot haveaccess to the medication. This is something that you and your doctorneed to discuss. Nobody else needs to approve this.Jeff


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## linda48846 (Nov 5, 2001)

Oh, I can't believe it!!! Yea! There's hope that I will have my miracle medicine back! I am sooooooooo happy right now - that if I'm not careful I may mess my pants!!!!!!!!!!!!Thank you so much Jeff and everyone else who helped to make this possible!!!!Bless you all!!!!


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## *Luna* (Nov 19, 2001)

I'm still


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## Jeffrey Roberts (Apr 15, 1987)

CBS Evening News ran a short piece on June 7. I've placed the video on-linefor anyone who would like to see it.You can watch or download it from the link below. The voice is a littleout of sync but you'll get the gist. The video might be a little blotchyif you watch it while it downloads. After it downloads just play it againin your video player. The segment is about 25 seconds long.The file is 4Mb. in length so dial-up modem people have been warned! http://www.ibsgroup.org/other/cbsnews_060702.mpg Enjoy!Jeff


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## MarkinCA (Mar 23, 2000)

"Given that men were receiving Lotronex off-label from the beginning, there is nothing in this new restricted marketing that says men cannot haveaccess to the medication."Jeff, are you sure about this? I am well-aware of off-label prescribing, which is how men got Lotronex in the first place.But now it's not going to be sold in the normal way. It's under a restricted regime. The FDA and GSK announcements specified that it would be available "only for women."I WANT YOU TO BE RIGHT!!!But how do we get around the specific terms of these restrictions?Mark


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## WD40 (Jun 7, 1999)

LotronexLover, when I saw the article, you were literally the first person I thought of!


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## carolauren (Mar 14, 2002)

Markin, I did a quick read-through of the documents from FDA--From the Physician Attestation sheet:


> quote: I understand that treatment benefits of Lotronex in populations other than adult women with D-predominant IBS have not been established.


From the Patient-Physician Agreement:


> quote: Lotronex is only for women with very bad IBS...Lotronex has not been shown to help men with IBS...


I think there is wiggle room here. The agreements do not say doctors *cannot* prescribe for men, only gives the indication for women which was shown in the clinical studies. In clinical practice, we know that some men benefitted greatly from it. If you hadn't been on the drug before, the trick is going to be finding a doctor who will do this, in essence, going off-label as Jeff says.If a man had been on it already with good results, I would think his doctor would find this persuasive enough to put him back on it.


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## MarkinCA (Mar 23, 2000)

I sure hope you're right.It partly depends on whether the specifics of the overall FDA policy supercede the wording of the physicians' agreements. A courageous doctor is just going to have to try it.There's also the secondary question of whether the miserly insurance companies will cover it for men. But of course the most important question is whether men will be able to slip through those cracks and get it in the first place.We know that a significant number of men were taking Lotronex before the withdrawal. Does anyone know if ANY men were among those handful of people who had the adverse reaction?Mark


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## DigestDan (Nov 30, 2000)

I was one of the men who took Lotronex very successfully for almost a year. Even at a low dose - one-half a pill per day - it changed my life. I have been involved in writing letters and calling the FDA and GSK since the day it was withdrawn in Nov. 2000. I am hoping and praying that we men will be allowed to benefit from this. I, also, wonder whether the new regulations might preclude off-label prescriptions.....Dan


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## JuliaNYC (Apr 20, 2000)

Dan, I read the material posted on the FDA website (many documents) pretty thoroughly and it doesn't appear that the off-label question is addressed one way or the other. I think it's going to be more of a question of whether a doctor is willing to do it. Take a look at the attestation form and the patient form on the FDA website and the approval letter the FDA sent to GSK and see what you think. Julia


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## DigestDan (Nov 30, 2000)

Julia - Thanks. I did look at it, and don't know what to think. Off-label is not mentioned, or prohibited, for that matter. We do need some clarification about this...Dan


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## karoe (Sep 22, 1999)

In addition to the lifesaving help this will be for those who need the drug, think of the AWARENESS OF IBS that this entire process has caused!! More awareness=more interest=more research!!! Kudos to all of those involved in this effort!! IBS on the CBS nightly news...never thought I'd see THAT!!!


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## LotronexLover (Jan 10, 2001)

(above) That's too funny.This is such a great week (despite my flare ups). We get Lotronex back and I find the greatest GI ever. As you all know...I have had terrible experiences with GI's. I now found Dr. Mushnik in Voorhees







, NJ. Oh my, this man knows his stuff, has character, listens to me, is caring, and is SOOooo pro-Lotronex. The intestinal fairy has shined upon me!!!!!!


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## carolauren (Mar 14, 2002)

Excellent about finding this doc, LL! You'll be all set in a few months!


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