I'm not looking at it as complaining. I'm looking at it as giving my input in favor of the drug. So I say we should be contacting both the FDA and Glaxo. Seems to me that Glaxo wouldn't want to withdraw a medication, unless it has been so much less profitable than they thought it would be, that they figured it's not worth it to try to keep it on the market.I'm troubled by the mixed messages....the FDA says that Glaxo wouldn't compromise, Glaxo says the FDA wouldn't compromise. So what's the real deal?Now, if we REALLY want to "complain", IMO we should be complaining to those busybodies at Public Citizen....Colleen
Missycat made a good point that the FDA cannot withdraw a product from the market - the pharmaceutical co.voluntarily withdraws it. The pharmacist at Glaxo told me that had they not withdrawn Lotronex, the FDA would have taken it to the next legal step - so basically, if the FDA "recommends a withdrawal" - it's withdrawn.Missycat also has a very good post toward the end of page 2 of Jeff's big post.From my conversations today, the FDA and Glaxo are making exactly the same claims - they each proposed compromises to restrict access to the drug, certify doctors and pharmacists, etc etc - and that the restrictions were too strict/lenient (depending on which one) to make it work. So.... we get screwed. Bottom line is that the millions that Glaxo has invested in research, development, clinical trials, distribution, & education ON TOP OF the refunds to patients they are now being forced to give - couldn't be that easy to walk away from. Even if profits are not and will not be huge, it is better than no revenue at all from such a huge 'upfront' investment.Yes, they can take the research that was the basis for Lotronex and re-configure it into new and possibly less dangerous drugs, but be realistic - by time that gets through the FDA, it will literally be years!I CAN'T GO THAT LONG WITHOUT LOTRONEX!!PLEASE BOMBARD THE FDA WITH YOUR 'TRUE LIFE' STORIES OF LIVING WITH IBS!!! I know it's a long shot, but something has to make them understand the consequences of this action!
ok, misspatience, I must lend a cautios tone towards the busy bodies. While those busy bodies are preventing me from geting my meds, they are also making sure I stay alive.My life sucked without Lotronex. I am horrified at a life without it, BUT, I would be ALIVE. And we must keep that in perspective. I know what I'll have to go through again without it. I know it will SEVERLY hamper my life. That it will not be normal again, etc. But life, while in pain and heartache to me is more important then death.Smack me upside the head if you disagree but please remember I myself understand the EXTREME difference it makes in my life and do have some empathy and understanding of it too. So I'm not out of touch with what many of us might go through.Anyway, I sent out prayer requests to all my friends today, I suggest we ask for prayer from anyone we feel comfortable asking.Grace and Peace,Keith------------------You're always welcome to visit my webstite at www.graceofchrist.org
To really understand why Lotronex is gone, look at the courts in Florida. Ongoing litigation (in that case about the presidential election) is the American culture. Why would Glaxo want to take on all the class-action and/or other lawsuits it would certainly have after the FDA put out warnings? We're out of luck about Lotronex for a long time to come. The next drug on the horizon is for IBS-C. Don't be surprised if the company decides to keep it off the market in the US. I'm checking with friends in Mexico to see if Lotronex is available there. Hell, if they can smuggle in all that marijuana and cocaine, Lotronex should be a piece of cake.
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