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Dear Friends:Lotronex Was Withdrawn From the Market In 2000, but Some Want It Back In response to repeated requests from people with irritable bowel syndrome (IBS), the FDA is now re-examining the status of the controversial drug Lotronex. According to a letter sent to patients by the FDA's Division of Drug Information, a tentative meeting has been set for April 22 to hear comments from an FDA advisory committee and the public about the drug. The FDA approved Lotronex in February 2000 to treat specific types of the intestinal illness, but it was withdrawn from the market nine months later after several life-threatening reactions and at least five deaths occurred in people given the drug. Lotronex was the first new drug in years to be approved to treat IBS, and its popularity quickly soared among people with the often-debilitating disease. Nearly half a million prescriptions were given during its brief availability. Since it was taken off the market, the drug's manufacturer, GlaxoSmithKline, has been in discussions with the FDA. They are exploring ways to create safety measures to ensure Lotronex is used only by people in whom the benefits would exceed the risks, the letter says. The FDA's letter states that IBS patients have commented that the agency is applying a different set of review standards in considering the risks and benefits for treatments for IBS -- an allegation denied in the letter. "There is little data currently available regarding specific risk factors, how patients can recognize emerging serious adverse events, or how Lotronex can be used to avoid or alleviate these risks. Under these circumstances, all IBS patients treated with Lotronex must be considered at risk for serious adverse events," write the authors. The FDA says the IBS community will have a voice in considering the risks and benefits of the drug, and it will include an IBS patient on the advisory committee. If you have additional questions about Lotronex or other drugs, call the FDA's Division of Drug Information at (888) INFO-FDA or email druginfo###cder.fda.gov. Sincerely,Stephen M. Paul, Ph.D.www.neopharmica.comI don't know if anyone else received this, but I thought you all might be interested
 

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Thanks for posting this, Bev. The part of the letter that discusses that there is no way of determining who will be at risk for developing complications really needs to be addressed. I would suggest everyone write to the cder email address and ask them "What risk management plans are in place for drugs like Viagra (which can cause heart attacks), Accutane (which can cause suicidal behavior), aspirin and other anti-inflammatory drugs (which can cause serious intestinal bleeding), and many others on the market that contain serious risk factors. Again, let's ask them to share with us what risk management plans are in place for all of these drugs, then we can determine whether or not their denial of a double standard is legit.I believe you now need to sign a waiver to use Accutane, why aren't we being given this option? These are the questions I'd like answered.Maria
 

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I got the FDA letter in my e-mail this morning. I wonder if it means that anyone other than Dr. Wood**** will be interested in my comments now. I've written to so many FDA officials (as we all have) since 11/2000, and only Dr. Wood**** has ever answered. I agree completely with Maria on the issue of risk management plans: Why is Lotronex different from any other high risk drug? I also noted in the full text of the FDA letter that there were several references to "numerous" deaths and adverse effects. From all the other FDA information I've read, then number of deaths was under 10 and the cases of ischemic colitis were under 100. with 300,000 prescriptions written, I'm not sure "numerous" is an accurate way to characterize these numbers.
 
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