# FDA Warns against Lotronex



## Mike NoLomotil (Jun 6, 2000)

FDA WARNS AGAINST BOWEL DRUGWashington-AP: The government is warning women that Lotronex, a popular new treatment for Irritable Bowel Syndrome, sometimes causes severe intestinal side effects-some requiring surgery.The Food And Drug Administration announced Thursday August 24, 2000 it had ordered GLAXO WELLCOME INC. to attach to every Lotronex bottle a plain-English pamphlet explaining the risk.At least 19 women have suffered the side effects-either a potentially life-threatening intestinal inflammation called ischemic colitis or severe constipation-and the FDA has preliminary reports of another 14 cases since Lotronex hit the market six months ago.GLAXO said "only a handful of the estimated 230,000 people who have tried Lotronex have suffered 'SERIOUS PROBLEMS'".GLAXO also is mailing a warning to thousands of doctors this week to help reduce the number of prescriptions physicians are writing for women who should not use it.Irritable Bowel Syndrome affects up to 15 percent of Americans, mostly women, and involves chronic or recurrent abdominal pain, the urgent need to go to the bathroom, and either frequent diarrhea or constipation orboth.


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## Jeffrey Roberts (Apr 15, 1987)

Friday August 25 2:38 AM ET FDA Warns of Bowel Treatment Effects By LAURAN NEERGAARD, AP Medical Writer WASHINGTON (AP) - A popular new treatment for irritable bowel syndrome could cause severe intestinal side effects - some requiring surgery - that have already affected at least 19 women. The Food and Drug Administration announced Thursday it had ordered Glaxo Wellcome Inc. to attach to every bottle of Lotronex a plain-English pamphlet explaining the risk, and that women should stop taking it at the earliest sign of a problem. Women have reported either a potentially life-threatening intestinal inflammation called ischemic colitis or severe constipation, and the FDA has preliminary reports of another 14 cases since Lotronex hit the market six months ago. Some cases apparently were caused by doctors giving Lotronex to women who shouldn't have taken it, sparking the FDA to order the unprecedented straight-to-the-patient warning brochures called ``MedGuides.'' The FDA, shaken by a recent spate of drugs that had to be banned, is hunting new ways to swiftly counter side effects of newly approved prescription drugs. Lotronex will test whether the MedGuides help. A consumer advocacy group, however, called the move insufficient. ``We do think this drug should come off the market, and will file a petition to get it off,'' said Dr. Sidney Wolfe of the group Public Citizen, who said he fears a woman eventually will die of the side effects. ``The risks clearly outweigh the benefits.'' But the FDA counters that if patients learn the early signs of a side effect, they can stop taking Lotronex before they have trouble.  ``This drug works in some people and it doesn't work in others,'' said Dr. Victor Raczkowski, FDA's deputy chief of gastrointestinal drugs. The new warning should ensure that ``the patients most likely to benefit from the drug and least likely to have serious side effects take it.'' Glaxo also is mailing a warning to thousands of doctors this week to help reduce the number of prescriptions physicians are improperly writing for women who shouldn't use the drug, said vice president James Palmer. Lotronex is the first new therapy in decades for irritable bowel syndrome, a mysterious disorder that affects up to 15 percent of Americans, mostly women. IBS involves chronic or recurrent abdominal pain, the sudden and urgent need to go to the bathroom and either frequent diarrhea or constipation or both. Lotronex offers modest relief to women whose main IBS problem is diarrhea. It doesn't work for men. About one of every 700 Lotronex users will develop ischemic colitis, says the new MedGuide. Also, the drug can cause constipation so severe that patients need hospitalization, even surgery, to unblock their intestines. In the worst case, one patient needed her colon removed. The FDA's top warnings: -Do not ever take Lotronex if you are constipated most of the time or ever have had severe constipation. If you have severe or worsening constipation while taking Lotronex, stop using it immediately and call your doctor. -Stop using Lotronex and call your doctor immediately if you have new or worsening pain in the lower abdomen, bloody diarrhea or blood in the stool. These are early symptoms of ischemic colitis. -Because Lotronex does not cure IBS or work for everyone, quit using it if your symptoms do not improve within four weeks. -Do not take Lotronex if you have ever had ischemic colitis or such other intestinal disorders as Crohn's disease, ulcerative colitis or active diverticulitis. - On the Net: The MedGuide for Lotronex is available on Glaxo's Internet site, http://www.lotronex.com.[/URL]


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## Jeffrey Roberts (Apr 15, 1987)

Thursday August 24 6:43 PM ET U.S. Toughens Warnings on Glaxo Bowel Drug By Lisa Richwine WASHINGTON (Reuters) - U.S. health officials said on Thursday they were strengthening warnings on Glaxo Wellcome's (GLXO.L) irritable bowel drug Lotronex and requiring distribution of consumer-friendly information about possible side effects. The Food and Drug Administration said Lotronex would be the first prescription drug to carry an agency-approved medication guide to help patients recognize rare but serious side effects. The information should help patients recognize early signs of serious side effects, which include severe constipation and a serious condition called ischemic colitis that restricts blood flow to the intestines, the FDA said. If patients contact their doctors at the first hint of trouble, they can minimize the chance of serious harm, said Dr. Victor Raczkowski, deputy director of the FDA office that evaluated Lotronex. ``By giving patients the early warning signs of some the things that could progress to more severe complications, we feel they will be prevented,'' Raczkowski said in an interview. Those measures did not satisfy the consumer group Public Citizen, which said it was preparing a petition asking the FDA to take Lotronex off the market. Dr. Sidney Wolfe, director of Public Citizen's Health Research Group, said irritable bowel syndrome was not serious enough to justify a treatment with side effects that could turn fatal. Treatment with Lotronex ``converts a relatively benign disease into a life-threatening situation,'' Wolfe said. ``It's only a matter of luck that no one has died (from Lotronex) thus far.'' Irritable bowel syndrome is a sometimes disabling disorder that afflicts an estimated 25 million Americans, most of them women. Symptoms include frequent diarrhea, constipation or both as well as abdominal pain and bloating. Treatments had been limited before the FDA approved Lotronex in February for women with irritable bowel syndrome whose main symptom is diarrhea. When it debuted, Lotronex included warnings about the possibility of rare cases of ischemic colitis. Now, the Lotronex label will advise physicians not to prescribe the drug for women considered at higher risk for serious side effects. That includes women with a history of bowel problems such as intestinal obstructions, Crohn's Disease, ulcerative colitis or ischemic colitis as well as active diverticulitis. Also, women should not start taking Lotronex while they have constipation, the new label says. The FDA has received 11 reports of serious constipation in patients taking Lotronex, some requiring hospitalization or surgery, Raczkowski said. In clinical trials before the drug was approved, no serious constipation was seen. Four cases of ischemic colitis appeared in clinical trials, and the agency tallied eight more from the time the drug hit the market until June 1. Four patients were hospitalized, but all 12 recovered without serious harm, the FDA said. Since June 1, another 10 confirmed or suspected cases have been reported to FDA, Raczkowski said. The FDA estimates the chances for developing ischemic colitis while taking Lotronex are about 1 in 700, Raczkowski said. Under a 1999 regulation, the FDA can require pharmacists to distribute medication guides with agency-approved language to help consumers understand safety risks. The guide for Lotronex will warn consumers to contact their doctor immediately if they develop severe constipation, have constipation with increased abdominal discomfort or notice signs of ischemic colitis. Those signs include new or worsening lower stomach pain or bloody stools. Glaxo Wellcome spokesman Doug Stokke said the company on Wednesday sent letters to about 500,000 physicians, pharmacists and other health care professionals informing them of the new safety information. The medication guides were in production and should be distributed beginning next month, Stokke said.


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## Guest (Aug 27, 2000)

Thanks Jeff and Mike for this interesting article. I was just about to post a question about this because a few nights ago on CBS Evening News, there was something about Lotronex that the FDA was warning about, but I caught the tail end of the story. I went to CBS's web site and of course found nothing about the warning they talked about! Never thought about coming here.The interesting thing is that I was reading and read that people with a previous diagnoses of crohn's, etc.. shouldn't take this drug. Well, before my gi doc told me in Feb. of this year that I had IBS, I had been diagnosed with crohn's for 2 yrs. before and was given the meds that they give to crohn's patients. And now I'm taking Lotronex, but have noticed an improvement in my symtoms and don't seem to have any life threatening side effects. Thanks again for the info. and now I'll have to ask my doc about the Lotronex and a previous dx of crohn's.Brandi


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## Mike NoLomotil (Jun 6, 2000)

BRANDI:If you are OK with it, just watch for any changes and do not "panic". Statistics = "some" not "all" and you are not gaurantedd to fall into any "some" category. But you should discuss it with your doc, and if he agrees you seem to tolerate it fine, just educate youraelf to the warning signs and be aware for the first sign of anything.I am glad you are gtting some relief!MNL


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