Type of Spiritual Experience
A description of the experience
Alosetron hydrochloride (initial brand name: Lotronex; ) is a 5-HT3 antagonist used for the management of severe diarrhea-predominant irritable bowel syndrome (IBS) in women only.
Alosetron was withdrawn from the market in 2000 owing to the occurrence of serious life-threatening gastrointestinal adverse effects, but was reintroduced in 2002 with availability and use restricted.
The cumulative incidence of ischaemic colitis was 2 in 1000, while serious complications arising from constipation (obstruction, perforation, impaction, toxic megacolon, secondary colonic ischaemia, death) was 1 in 1000.
A 1999 review performed by FDA medical officer John Senior, indicated that 27% of patients experienced constipation. The phase III trial reported constipation occurred in 30% and 3% of patients in the alosetron and placebo groups, respectively. It was cited as the most important reason for patients dropping out of the study.
On June 7, 2002, the FDA announced the approval of a supplemental New Drug Application (sNDA) that allows restricted marketing of Lotronex (alosetron hydrochloride), to treat only women with severe diarrhea-predominant irritable bowel syndrome (IBS). It was the first drug ever returned to the U.S. market after withdrawal for safety concerns
On Jan, 6, 2016: 6,568 people reported to have side effects when taking Lotronex. Among them, 3 people (0.05%) have Hallucination.
Time on Lotronex when people have Hallucination :
|< 1 month||1 - 6 months||6 - 12 months||1 - 2 years||2 - 5 years||5 - 10 years||10+ years|
On Jan, 6, 2016: 6,568 people reported to have side effects when taking Lotronex. Among them, 23 people (0.35%) have Death.