LOTRONEX® in Severe Diarrhea-Predominant Irritable Bowel Syndrome (IBS-D)

Exclusion Criteria

• •1. Has had a period of 3 consecutive days without a bowel movement in the past 14 days.
• •2. In the past 14 days, has had evidence of chronic or severe constipation, or has a history of chronic or severe constipation, or a history of sequelae from constipation.
• •3. Has recurrent bowel obstruction of the small intestine or colon.
• •4. Has had bloody diarrhea or abdominal pain with rectal bleeding in the past 14 days (except rectal bleeding due to hemorrhoids).
• •5. Has a known biochemical or anatomical abnormality of the gastrointestinal tract.
• •6. Has a history of thrombophlebitis or hypercoagulable state.
• •7. Has a history of atherosclerosis.
• •8. Has any medical or surgical condition that in the judgment of the investigator makes the patient an inappropriate candidate for Lotronex® therapy (e.g., an unstable cardiovascular, autoimmune, renal, hepatic, pulmonary, endocrine, metabolic, gastrointestinal, hematologic, or neurological condition; recent or ongoing malignancy; evidence of hepatic dysfunction; or renal impairment.)
• •9. Mental impairment of inability to understand the medication guide and instructions for study participation or refusal to comply with protocol.
• •10. Current (within 7 days from start of Lotronex® use) use of fluvoxamine.
• •11. Chronic (≥ 6 months) use of narcotics or opioids.
• •12. The patient has used an investigational drug or participated in an investigational study within 30 days of Visit 1/ Screening Visit.
• •13. The patient is hypersensitive or has a known negative response to 5-HT3 antagonists.
• •14. Had a significant adverse event during previous treatment with Lotronex® or is currently using Lotronex®.