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Discussion Starter · #1 ·
Hi Lotronex Lover I just saw your post, but I can assume from the short message, WE WON?? We have it back? I can hardly believe it!! But I want details--where can I get the info on what, how, when, restrictions, who can prescribe, etc? DETAILS, PlEASE!! Love you all--Kitty
 

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Basically back with restrictions. FDA & glaxo to talk. 4 - 6 months until re-marketed. Go to NEWS , type in LOTRONEX. There are about 7 articles it's in. (I am sorry I can't get into it - I am 15 min. late for my 30th B day dinner & friends are calling me on cell wondering where I am). I will try to e-mail you news. PLEASE post for others. I don't know how.
 

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Oh PooP!!!! It won't let me copy & paste. Please go to NEWS on who ever you server is. TYPE Lotronex & please PLEASE tell everyone else on the BB the details. I gave you the major details. But please fill in the rest.
 

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Discussion Starter · #5 ·
Ok, this is also where I found an article that capsulized the meeting. Go to www.msnbc.com and then click on the bar on the left labeled "health". Scroll down and click on the "bowel drug" thread. Kitty
 

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'A life without Lotronex is a miserable existence,' said a tearful Diana Hoyt of Atlanta, who described swallowing four anti-diarrheal pills and donning a diaper just to spend a few minutes asking the FDA for the only pill that ever made her feel well. IF THE Food and Drug Administration heeds the panel's advice, Lotronex will be tough to get - prescribed only by doctors who have undergone special training to use it and given only to the sickest patients, who must register in a national database that monitors how well they fare. The panel vote followed emotional pleas from patients with irritable bowel syndrome, or IBS. The condition afflicts millions of Americans with diarrhea, constipation, abdominal pain and other symptoms that can be debilitating. Patients recounted severe pain and embarrassing episodes when they could not reach a bathroom in time. Many said they avoided social situations and had to rearrange work and limit travel. "A life without Lotronex is a miserable existence," said a tearful Diana Hoyt of Atlanta, who described swallowing four anti-diarrheal pills and donning a diaper just to spend a few minutes asking the FDA for the only pill that ever made her feel well. With Lotronex, "suddenly I was living a normal life," patient Terry Olifiers said. "I could now leave my house without fear. I no longer had the embarrassment of having to change my clothes at work or running into restrooms." Two attorneys for people injured by the once-popular drug, which was pulled off the market in November 2000, argued it's too risky to sell again. One played a video of a Florida woman left mostly paralyzed and unable to breathe on her own after a burst colon attributed to Lotronex caused a brain-damaging infection. Her attorney asked if the FDA should allow the sale of Lotronex again. "No, don't let them," Gloria Lockett gasped on the videotape. "She would have been better off dead," attorney Dennis Larry said later. PATIENTS WILLING TO ADOPT RISKS The risk is worth it, responded 10 sufferers of irritable bowel syndrome. "Have you ever soiled your pants in public?" Brenda Compton snapped at one of the attorneys. She turned to face the panel of solemn-faced physicians judging the issue for FDA. "I'm not asking you, I'm begging you, bring the drug back." Lotronex initially was lauded as the first new therapy in decades for irritable bowel syndrome, or IBS, which afflicts up to 11 percent of Americans, mostly women. The illness isn't life-threatening, but causes misery: chronic abdominal pain, sudden and urgent need to go to the bathroom and either frequent diarrhea, constipation or both. Lotronex is only for the diarrhea-dominant type. After only nine months of sales in 2000, manufacturer GlaxoSmithKline pulled Lotronex off the market because of two side effects: a life-threatening intestinal inflammation called ischemic colitis and constipation so severe it could require surgery, even kill. The FDA has counted 238 reports of those side effects. Some 163 were hospitalized and 51 required surgery. Of 14 reported deaths, seven were probably caused by the drug, FDA says. In studies, Lotronex offered only modest overall relief for female IBS patients. But the most severely ill - estimated at 5 percent to 10 percent of IBS patients - seemed to benefit far more. It's not proved to work for men and is dangerous for anyone with constipation. "It is our intention to be extremely cautious with this medication," said Glaxo's Dr. James Palmer. Advertisement When he heard Lotronex was being pulled off the market, Atlanta architect Corey Miller raced from pharmacy to pharmacy to stockpile the drug, his only relief from the devastating condition. Miller calls it his miracle - until his hoarded stash ran out a few months ago. So Tuesday, he joined the other desperate patients to beg the FDA to let Lotronex sell again despite its risks. However, to win FDA approval to resume sales, Lotronex's maker is pledging major restrictions that would keep patients like Miller from buying it. PROPOSED RESTRICTIONS Glaxo's plan: Only physicians experienced in treating IBS could prescribe Lotronex; women would have to sign a form swearing they understand the risks; and pharmacists could fill only prescriptions bearing a special sticker showing that the form had been signed. Patients could only get a 30-day supply at a time - no refills without another doctor's visit - and would be told to try 1 milligram daily, half the originally recommended dose. They would be urged to see a doctor immediately if they have any symptoms of side effects, such as constipation, unusual abdominal pain or blood in the stool. FDA's advisers recommended some additional restrictions, stressing that the drug is only for the sickest patients, who must register on a national database to get the drug, and that physicians undergo some form of training to prescribe Lotronex instead of simply declaring themselves competent to do so. Glaxo also must perform audits or other tough monitoring to ensure the restrictions are working. The FDA isn't bound by its advisers' recommendations but typically follows them. But critics say the plan isn't tough enough to save lives, much less deter determined patients for whom it's not considered safe. Dr. Sidney Wolfe, head of Public Citizen's Health Research Group, a consumer group said the drug was too dangerous to bring back. A reintroduction "would be a serious public health mistake, likely, if not certain, to result in the need for the drug to be withdrawn again," he told the panel. The Associated Press and Reuters contributed to this report.
 
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