Summary of Adverse Reactions

Adverse Reactions Occurring in More Than 1% of Mesalamine Suppository Treated Patients (Comparison to Placebo)1

In the multicenter, open-label, randomized, parallel group study comparing the CANASA® 1000 mg suppository (HS) to that of the CANASA® 500 mg suppository (BID), there were no differences between the two treatment groups in the adverse event profile. The most frequent AEs were headache (14.4%), flatulence (5.2%), abdominal pain (5.2%), diarrhea (3.1%), and nausea (3.1%). Three (3) patients had to discontinue medication because of a treatment emergent AE; one of these AEs (headache) was deemed possibly related to study medication.1

In addition to the events observed in the clinical trials, the following adverse events have been associated with mesalamine containing products: nephrotoxicity, pancreatitis, fibrosing alveolitis and elevated liver enzymes. Cases of pancreatitis and fibrosing alveolitis have been reported as manifestations of inflammatory bowel disease as well.1

Mesalamine has been implicated in the production of an acute intolerance syndrome characterized by cramping, acute abdominal pain and bloody diarrhea, sometimes fever, headache and a rash; in such cases prompt withdrawal is required.



Information on this website is not intended to replace the advice of your physician(s). Please consider what you learn here a starting point for a conversation with your physician. All care of ulcerative proctitis and related conditions must be guided by the appropriate healthcare professional. CANASA® is a prescription drug.

References
1. CANASA® (Mesalamine, USP) Rectal Suppository 1000 mg Prescribing Information, October 2008.

 

CANASA® is available by prescription only.

CANASA® 1000 mg Suppositories are indicated for the treatment of active ulcerative proctitis.

CANASA® is contraindicated in patients who have demonstrated hypersensitivity to mesalamine (5-aminosalicylic acid) or to the suppository vehicle [saturated fatty acid esters (Hard Fat, NF)], or to salicylates (including Aspirin).

As with other mesalamine containing products, less common but possibly serious side effects such as acute intolerance syndrome, pericarditis and pancolitis may occur.

Patients on CANASA® 1000 mg, especially those on concurrent oral products which contain or release mesalamine and those with pre-existing renal disease, should be carefully monitored with urinalysis, BUN and creatinine testing.

Caution should be exercised when CANASA® suppositories are initially used in patients known to be allergic to sulfasalazine.

CANASA® was generally well tolerated in clinical studies. The most common side effects of CANASA® are dizziness (3%), rectal pain (1.8%), fever (1.2%), rash (1.2%), acne (1.2%), and colitis (1.2%).

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit http://www.FDA.gov/medwatch, or call 1-800-FDA-1088.