On January 28, 2020, FDA updated the warning for clozapine to include serious bowel problems caused by untreated constipation. Clozapine is currently approved to treat schizophrenia and reduce risk of suicidal behavior in patients with schizophrenia. Constipation is a known side effect of clozapine. The updated warning now includes other uncommon bowel problems caused by untreated clozapine-associated constipation such as bowel obstruction and death of the colon wall. These and other bowel problems have resulted in hospitalization, surgery, or death. The risk of constipation is increased with higher doses of clozapine and its use in combination with other drugs that cause constipation.
Patients prescribed clozapine should contact health care providers if their bowel movements are less frequent than normal, if they have difficulty passing gas, or other symptoms of constipation. Signs and symptoms of serious bowel problems include nausea, vomiting, bloating, and stomach swelling or pain. Patients should contact health care providers right away if experiencing these symptoms.
Health care providers should evaluate bowel function before prescribing clozapine and throughout treatment. Providers should encourage patients to remain hydrated while taking clozapine to prevent constipation and may consider prophylactic laxative treatment when starting clozapine in patients with a history of constipation or bowel obstruction.
Consumers should report any adverse reactions experienced from this product to their provider and the FDA MedWatch Adverse Event Reporting Program online at: www.fda.gov/medwatch/report.htm
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