Lotronex
FDA approved Lotronex on February 9, 2000 for use in the treatment of IBS in women whose predominant bowel symptom is diarrhea. FDA subsequently received numerous reports of serious and fatal gastrointestinal adverse events in patients that were given Lotronex. As of November 10, 2000, FDA had received and 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 the 70 cases, 34 resulted in hospitalization without surgery, 10 resulted in surgical procedures, and three resulted in death. FDA has received two additional reports of death that the agency did not classify as being cases of ischemic colitis or severe complications of constipation.
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.
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; or
-
current Crohn's Disease or ulcerative colitis, or a history of such a disease.
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:
Develop a Medication Guide that communicates to patients the risk of rare but serious side effects while taking Lotronex and which tells patients how they can recognize those risks and take early action to prevent serious harm.
Revise the professional labeling to inform health care providers about these possible serious side effects of Lotronex, to describe the types of patients that should not receive Lotronex, to explain when Lotronex therapy should be interrupted or stopped permanently, and to describe the types of patients that are most likely to benefit from Lotronex.
Distribute a "Dear Health Care Practitioner" and a "Dear Pharmacist" letter, which the manufacturer of Lotronex has sent to health care providers to convey new information on safety.
» top
