Latest News

FDA strengthens warning regarding clozapine, serious bowel complication risk


 

The Food and Drug Administration is strengthening a previous warning regarding the uncommon risk of serious bowel complications associated with the schizophrenia medication clozapine (Clozaril, FazaClo ODT, Versacloz).

FDA icon Wikimedia Commons/FitzColinGerald/ Creative Commons License

According to the FDA press release, dated Jan. 28, clozapine affects bowel function in a majority of patients, and constipation is a common adverse event associated with clozapine use. This can uncommonly progress to serious bowel complications, including complete bowel blockage, and can result in hospitalization or even death if the constipation is not diagnosed and treated quickly.

Patients should contact their health care clinician if their bowel movements are less frequent, they have a bowel movement less than three times a week, they have hard or dry stool, or they have difficulty passing gas. Urgent care is needed if patients are experiencing nausea, vomiting, belly pain, or bloating, according to the FDA.

In addition, health care clinicians should evaluate bowel function before beginning clozapine treatment, avoid coprescribing with other anticholinergic medicines, advise and question patients about the risks of clozapine and their bowel movements, monitor patients for complications, and consider prophylactic laxative treatment in patients with a history of constipation or bowel obstruction, the FDA added.

Recommended Reading

Health care reform may cut behavioral admissions
MDedge Emergency Medicine
Promoting recovery for patients with schizophrenia
MDedge Emergency Medicine
FDA warns of potentially fatal skin reaction with ziprasidone
MDedge Emergency Medicine
FDA calls study of unexplained olanzapine deaths ‘inconclusive’
MDedge Emergency Medicine
AAN: Largest neuroleptic malignant syndrome study finds predictors of poor outcome
MDedge Emergency Medicine
Rate of schizophrenia-related ED visits twice as high in men
MDedge Emergency Medicine
FDA: Olanzapine can cause serious skin reaction
MDedge Emergency Medicine
Statement warns of drugs causing or exacerbating heart failure
MDedge Emergency Medicine