Lotronex

Lotronex is prescribed to treat chronic or severe irritable bowel syndrome (IBS) in women. It works by blocking the action of serotonin in the intestines, which slows the movement of stool throughout the body. IBS is diagnosed when the patient has had diarrhea or other symptoms for more than six months. Lotronex has not been seen to be effective in men. It was approved by the FDA in 2000.

Lotronex has been associated with serious side effects such as ischemic colitis—including rectal bleeding, bloody diarrhea and abdominal pain. Because of these dangerous side effects, Lotronex was voluntarily removed from the market in 2000—only a few months after it had been approved.

In 2002, the FDA revisited this issue, approving a supplemental New Drug Application (sNDA) that allowed restricted marketing of the drug. Now, Lotronex has been approved to treat only women with severe diarrhea-predominant irritable bowel syndrome. It also requires that patients are fully informed of the risks that go along with taking Lotronex.

Serious side effects may include:

• New or worsening stomach pain
• Bleeding from your rectum or blood in your stools
• Fast or uneven heartbeats
• Less serious Lotronex side effects may include:
• Mild stomach discomfort, bloating, or nausea
• Mild constipation
• Burping with heartburn
• Rectal hemorrhoids
• Bloating or gas
• Headache
• Skin rash