U.S. Food and Drug Administration • Center for Drug Evaluation
and Research |
U.S. Food and Drug Administration • Center for Drug Evaluation
and Research |
 |
Drug Information |
 |
|
|
Questions and AnswersLOTRONEXÔ (LOW-trah-nex) Tablets
What is Glaxo Wellcome telling health care providers today? The manufacturer of Lotronex (alosetron) tablets -- a drug used to treat irritable bowel syndrome in women -- has voluntarily decided to withdraw Lotronex from the market after discussions with the Food and Drug Administration (FDA) on how to best manage risk. This drug has been associated with reports of serious side effects such as intestinal damage as a result of reduced blood flow to the intestine (ischemic colitis), severely obstructed or ruptured bowels (complications of severe constipation), and death. What is Lotronex? Lotronex is a prescription medicine used to treat women with irritable bowel syndrome (IBS) who have diarrhea as their main symptom (diarrhea-predominant IBS). Lotronex has not been shown to help men with IBS. What is IBS? IBS is also called irritable colon and spastic colon. IBS causes lower abdominal pain and discomfort, urgency (a sudden need to have a bowel movement), and irregular bowel habits, such as diarrhea or constipation. In some people IBS causes mostly constipation; in others, mostly diarrhea; some people have alternating periods of diarrhea and constipation. Lotronex was approved only for women with diarrhea-predominant IBS. Lotronex should not have been used by women who have constipation as their main IBS symptom. IBS is a symptomatic disease that can cause significant discomfort but which does not result in complications that need bowel surgery (an operation). What previous actions have FDA and the manufacturer taken? FDA has worked with the manufacturer of Lotronex to:
What were some of the options FDA proposed to the manufacturer to manage risk? There are no current methods to anticipate which patients may suffer an adverse reaction. It is for this reason, the FDA discussed with the company other risk management options, including restricted distribution or marketing withdrawal. Because the FDA believes that IBS can be debilitating for some women, we discussed the option of a restricted drug distribution program with the company. The goals of a restricted use program would include:
Why did FDA approve Lotronex in the first place? FDA based its approval on the results of two 12-week double-blinded, placebo-controlled clinical trials. A total of 1273 non-constipated women, who met specific pain and stool consistency criteria, were enrolled. In each study, Lotronex was significantly more effective than placebo in providing relief from IBS pain and discomfort and in reducing the percentage of days with urgency. Treatment with Lotronex also resulted in firmer stools and a significant decrease in stool frequency. Prior to approval, four cases of ischemic colitis were observed in clinical studies and were discussed in November 1999 meeting of FDA’s Gastrointestinal Drugs Advisory Committee. At that time these adverse events were transient, mild-to-moderate in nature and reversible upon discontinuation of the drug. FDA has been closely monitoring Lotronex since cases of intestinal damage as a result of reduce blood flow to the intestine (ischemic colitis) and severely obstructed or ruptured bowels (complications of severe constipation) were first reported to FDA following approval of the drug on February 9, 2000. The FDA convened a second public advisory committee meeting on June 27, 2000 where risk management options in response to the serious adverse event reports were discussed. The consensus of the advisory committee members was that both doctors and patients must be informed of the potentially serious adverse events associated with Lotronex. As of November 10, 2000, FDA has reviewed a total of 70 cases of serious post-marketing adverse events, including 49 cases of ischemic colitis and 21 cases of severe constipation. Of these 70 cases, 34 resulted in hospitalizations without surgery, 10 resulted in surgical procedures and three resulted in death. What should I do if I am currently taking Lotronex? We encourage those people who have taken Lotronex to contact their doctor and discuss the appropriate follow-up, and alternative treatments. Any decision about which drug product to take to treat your symptoms should be made in consultation with your doctor based on an assessment of your specific treatment needs, specific risk profile, and other factors. FDA does not regulate the practice of medicine and cannot comment on, or recommend, a course of treatment for any individual. Will Lotronex be recalled from the pharmacy? The FDA did not request a recall of Lotronex. However, the company has indicated that they are planning to recall the product from pharmacies. Can my pharmacist continue to fill my prescription for Lotronex? At this time, Lotronex will remain in pharmacies until supplies are returned to the manufacturer or exhausted. Many pharmacies may choose to no longer fill prescriptions for Lotronex. Contact your pharmacist directly for more information. Is Lotronex approved in other countries? At this time Lotronex is also approved but not yet marketed in Mexico, Argentina, Brazil, and South Korea. How can I report a serious side effect with Lotronex to FDA? FDA encourages anyone aware of a serious adverse reaction, including consumers, to make a MedWatch report. You can report an adverse event in two ways:
Call 1-800-FDA-1088 Who manufactures Lotronex? GlaxoWellcome Inc. Where can I get more information relating to the withdrawal of Lotronex? To find out more about Lotronex from FDA: Visit our Drug Information web page at: www.fda.gov/cder Call Drug Information at: 888-INFO-FDA (888-463-6332)
FDA/Center for Drug Evaluation and Research |
