Lotronex (alosetron) is an oral medication used to treat severe cases of irritable bowel syndrome (IBS) in women who have diarrhea as a major symptom. Manufactured by Glaxo Wellcome, Lotronex is not effective in men with IBS.
Lotronex is prescribed for women who have predominantly diarrhea causing Irritable Bowel Syndrome (IBS).
Lotronex was approved by the FDA in 2000 to treat women with severe diarrhea-predominant irritable bowel syndrome (IBS) who have chronic IBS symptoms (generally lasting 6 months or longer).
Side effects commonly associated with Lotronex are headache, stomach upset, and hemorrhoids.
In 2000, Glaxo Wellcome withdrew Lotronex tablets from the market, as the drug was reportedly causing serious, sometimes fatal intestinal side effects including constipation and ischemic colitis–a serious complication caused by reduced blood flow to the intestines. The FDA studied 70 cases of adverse reactions to Lotronex, including 5 deaths. The main concern was the potential for damage to the intestine from either ischemic colitis or severe constipation.
Lotronex is contraindicated in patients with a history of chronic or severe constipation, intestinal obstruction, stricture, toxic megacolon, gastrointestinal perforation and/or adhesions, ischemic colitis, impaired intestinal circulation, thrombophlebitis, or hypercoagulable state, Crohn’s disease or ulcerative colitis, diverticulitis, severe hepatic impairment, and/or hypersensitivity to any component of the product.
What is Irritable Bowel Syndrome (IBS)?
IBS is a symptomatic disease that can cause significant discomfort, but which does not result in complications that need bowel surgery. 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.
Did FDA approve Lotronex in the first place?
Did FDA approve Lotronex? The FDA based its approval of Lotronex 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 the 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.
IBS Symptoms and Types
IBS symptoms include abdominal pain, bloating, and discomfort. However, symptoms can vary from person to person. Some people have constipation, which means hard, difficult-to-pass, or infrequent bowel movements. Often these people report straining and cramping when trying to have a bowel movement but cannot eliminate any stool, or they are able to eliminate only a small amount. If they are able to have a bowel movement, there may be mucus in it, which is a fluid that moistens and protect passages in the digestive system. Some people with IBS experience diarrhea, which is frequent, loose, watery, stools. People with diarrhea frequently feel an urgent and uncontrollable need to have a bowel movement.
Can I file a lawsuit if I have suffered damages from taking Lotronex?
Possibly. While all medications have certain, anticipated side effects, a drug manufacturer has a duty to inform physicians adequately regarding the known risks associated with its drugs. If a manufacturer fails to do so, it can be held responsible to patients who are injured as the result of inadequate warnings, under a legal theory known as “product liability.” Depending upon the particular circumstances of your case, damages may include recovery for any of the following:
- Past and future medical expenses
- Past and future pain and suffering
- Lost wages
- Loss of future earning capacity
- Emotional distress
If you or a loved one has experienced any health problems while taking Lotronex, you should contact your doctor immediately. You may also wish to contact an experienced Lotronex Side Effects lawyer to discuss your legal options. As all legal claims are subject to time limits, however, you may risk forfeiture of your right to financial compensation if you delay.