Alosetron - Warnings and Precautions
The following warnings and precautions are taken directly from the US FDA-approved drug label for Alosetron. This is the same information dispensing pharmacists read.
\u26a0\ufe0f Boxed Warning (Highest FDA Alert)
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 ] . 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 , Warnings and Precautions , ] . 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 complicatio
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.
Discontinue alosetron hydrochloride immediately if constipation occurs.
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).
Discontinue alosetron hydrochloride immediately if signs of ischemic colitis occur, such as rectal bleeding, bloody diarrhea, or new or worsening abdominal pain.
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 interval 1 to 3) through 3 months and was 0.3% (3 per 1,000 patients, 95% confidence interval 1 to 4) through 6 months.
Ischemic colitis has been reported with use of 1 mg twice daily and with lower doses.
A dose-response relationship has not been established.
Ischemic colitis was reported in one patient receiving placebo.
The patient experience in controlled clinical trials is insufficient to estimate the incidence of ischemic colitis in patients taking alosetron hydrochloride for longer than 6 months.
Alosetron hydrochloride should be discontinued immediately in patients with signs of ischemic colitis such as rectal bleeding, bloody diarrhea, or new or worsening abdominal pain.
Because ischemic colitis can be life-threatening, patients with signs or symptoms of ischemic colitis should be evaluated promptly and have appropriate diagnostic testing performed.
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