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boxed warning
WARNING: SERIOUS GASTROINTESTINAL ADVERSE REACTIONS Infrequent but serious gastrointestinal adverse reactions have been reported with the use of alosetron hydrochloride. These events, including ischemic colitis and serious complications of constipation, have resulted in hospitalization and rarely, blood transfusion, surgery and death. Alosetron hydrochloride is indicated only for women with severe diarrhea-predominant irritable bowel syndrome (IBS) who have not responded adequately to conventional therapy [see Indications and Usage (1) ] . Alosetron hydrochloride should be discontinued immediately in patients who develop constipation or symptoms of ischemic colitis. Patients should immediately report constipation or symptoms of ischemic colitis to their prescriber. Alosetron hydrochloride should not be resumed in patients who develop ischemic colitis. Patients who have constipation should immediately contact their prescriber if the constipation does not resolve after alosetron hydrochloride is discontinued. Patients with resolved constipation should resume alosetron hydrochloride only on the advice of their treating prescriber [see Dosage and Administration (2.1) , Warnings and Precautions (5.1) , (5.2) ] . WARNING: SERIOUS GASTROINTESTINAL ADVERSE REACTIONS See full prescribing information for complete boxed warning. Infrequent but serious gastrointestinal adverse reactions have been reported with the use of alosetron hydrochloride. These events, including ischemic colitis and serious complications of constipation, have resulted in hospitalization and, rarely, blood transfusion, surgery and death. Alosetron hydrochloride is indicated only for women with severe diarrhea-predominant irritable bowel syndrome (IBS) who have not responded adequately to conventional therapy. (1) Discontinue alosetron hydrochloride immediately in patients who develop constipation or symptoms of ischemic colitis. Do not resume alosetron hydrochloride in patients who develop ischemic colitis. (2.1, 5.1, 5.2)
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warnings and cautions
5 WARNINGS AND PRECAUTIONS Serious Complications of Constipation: May occur in some patients without warning. Includes obstruction, ileus, impaction, toxic megacolon and secondary bowel ischemia and in rare cases perforation and death have been reported. Risk is increased in patients who are elderly, debilitated, or taking medications that decrease bowel motility. (5.1) Discontinue alosetron hydrochloride immediately if constipation occurs. (5.1) Ischemic colitis: May occur in some patients without warning. Promptly evaluate patients with signs of ischemic colitis (e.g., rectal bleeding, bloody diarrhea, new or worsening abdominal pain). (5.2) Discontinue alosetron hydrochloride immediately if signs of ischemic colitis occur, such as rectal bleeding, bloody diarrhea, or new or worsening abdominal pain. (5.2) 5.1 Serious Complications of Constipation Some patients have experienced serious complications of constipation without warning. Serious complications of constipation, including obstruction, ileus, impaction, toxic megacolon and secondary bowel ischemia, have been reported with use of alosetron hydrochloride during clinical trials. Complications of constipation have been reported with use of 1 mg twice daily and with lower doses. A dose response relationship has not been established for serious complications of constipation. The incidence of serious complications of constipation was approximately 0.1% (1 per 1,000 patients) in women receiving either alosetron hydrochloride or placebo. In addition, rare cases of perforation and death have been reported from post-marketing clinical practice. In some cases, complications of constipation required intestinal surgery, including colectomy. Patients who are elderly, debilitated, or taking additional medications that decrease gastrointestinal motility may be at greater risk for complications of constipation. Alosetron hydrochloride should be discontinued immediately in patients who develop constipation [see Boxed Warning ] . 5.2 Ischemic Colitis Some patients have experienced ischemic colitis without warning. Ischemic colitis has been reported in patients receiving alosetron hydrochloride in clinical trials as well as during marketed use of the drug. In IBS clinical trials, the cumulative incidence of ischemic colitis in women receiving alosetron hydrochloride was 0.2% (2 per 1,000 patients, 95% confidence inte...
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adverse reactions
6 ADVERSE REACTIONS The following adverse reactions are described in more detail in other sections of the label: Complications of constipation [see Boxed Warning, Warnings and Precautions (5.1) ] Ischemic colitis [see Boxed Warning, Warnings and Precautions (5.2) ] Most common adverse reactions (incidence > 2% and > placebo) in clinical studies were constipation, abdominal discomfort and pain, nausea and gastrointestinal discomfort and pain. (6.1) To report SUSPECTED ADVERSE REACTIONS, contact Amneal Pharmaceuticals at 1-877-835-5472 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Patients with Irritable Bowel Syndrome: Table 1 summarizes adverse reactions from 22 repeat-dose studies in patients with IBS who were treated with 1 mg of alosetron hydrochloride twice daily for 8 to 24 weeks. The adverse reactions in Table 1 were reported in 1% or more of patients who received alosetron hydrochloride and occurred more frequently on alosetron hydrochloride than on placebo. A statistically significant difference was observed for constipation in patients treated with alosetron hydrochloride compared to placebo (p < 0.0001). Table 1: Adverse Reactions Reported in ≥ 1% of Patients with Irritable Bowel Syndrome and More Frequently on Alosetron Hydrochloride 1 mg Twice Daily Than Placebo Body System Adverse Reaction Placebo (n = 2,363) Alosetron Hydrochloride 1 mg twice daily (n = 8,328) Gastrointestinal Constipation 6% 29% Abdominal discomfort and pain 4% 7% Nausea 5% 6% Gastrointestinal discomfort and pain 3% 5% Abdominal distention 1% 2% Regurgitation and reflux 2% 2% Hemorrhoids 1% 2% Gastrointestinal: Constipation is a frequent and dose-related side effect of treatment with alosetron hydrochloride [see Warnings and Precautions (5.1) ] . In clinical studies constipation was reported in approximately 29% of patients with IBS treated with alosetron hydrochloride 1 mg twice daily (n = 9,316). This effect was statistically significant compared to placebo (p < 0.0001). Eleven percent (11%) of patients treated with alosetron hydrochloride 1 mg twice daily withdrew from the stud...
adverse reactions table
Table 1: Adverse Reactions Reported in ≥ 1% of Patients with Irritable Bowel Syndrome and More Frequently on Alosetron Hydrochloride 1 mg Twice Daily Than PlaceboBody System Adverse ReactionPlacebo (n = 2,363)Alosetron Hydrochloride 1 mg twice daily (n = 8,328)Gastrointestinal Constipation6%29%Abdominal discomfort and pain 4%7%Nausea 5%6%Gastrointestinal discomfort and pain 3%5%Abdominal distention 1%2%Regurgitation and reflux 2%2%Hemorrhoids1%2%