Lotronex is only for women with IBS who have diarrhea as their main symptom (diarrhea-predominant IBS). Women who have constipation as their main IBS symptom should not use Lotronex.
Lotronex treatment should not be started when women are constipated and is contraindicated in women with the following:
- a history of intestinal obstruction, stricture, toxic megacolon, gastrointestinal perforation, and/or adhesions;
- a history of ischemic colitis;
- active diverticulitis;
- current Crohn's Disease or ulcerative colitis, or a history of such a disease.
Lotronex is a prescription medication that was approved to treat Irritable Bowel Syndrome (IBS) in women. The FDA is advising patients who are taking Lotronex to contact their healthcare provider to discuss treatment alternatives.
On November 28, 2000, at the request of the Federal Drug Administration (FDA), the drug manufacturer, Glaxo Wellcome, announced that it would voluntarily withdraw Lotronex (alosetron hydrochloride) from the market. Glaxo Wellcome agreed to the withdrawal after the drug was linked to an increasing number of deaths, surgeries and hospitalization
Glaxo Wellcome agreed to withdraw Lotronex from the market after reports of five deaths in patients taking Lotronex, and numerous reports of severe constipation leading to intestinal obstruction and ruptured bowels. According to an FDA publication, as of November 10, 2000, the FDA had received 70 reports of serious adverse events associated with Lotronex, including 49 cases of ischemic colitis (a life-threatening intestinal inflammation resulting from inadequate blood flow to the intestine), and 21 cases of severe constipation. Of the 70 reported cases of adverse events, 34 resulted in hospitalization without surgery, 10 required surgery, and three died. The FDA has received two additional reports of death also believed to be related to Lotronex, raising the death count to five. Some of the patients who survived required the surgical removal of sections of their intestines.
The FDA approved Lotronex on February 9, 2000. Prior to approval, the FDA was aware that four patients receiving Lotronex in clinical trials had suffered the complication of ischemic colitis. However, these cases were described in FDA literature as "transient, mild-to-moderate in nature and reversible" once the patient stopped taking the drug. Glaxo Wellcome representatives denied that Lotronex had caused the ischemic colitis and stated any of the risks could be adequately managed. However, this does not appear to be the situation, and consequently, Lotronex has been removed from the market.