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

Cannabis use, potency linked to psychotic disorder risk
MDedge Family Medicine
Amphetamine tied to higher risk of new-onset psychosis than methylphenidate
MDedge Family Medicine
Early childhood infections tied to psychosis risk
MDedge Family Medicine
Anticholinergic drugs linked to dementia in older populations
MDedge Family Medicine
LAIs still underused for patients with psychosis
MDedge Family Medicine
Four genetic variants link psychotic experiences to multiple mental disorders
MDedge Family Medicine
Agitation in psychosis: Still no ‘magic bullet’
MDedge Family Medicine
Psychodiagnostic testing services: The elusive quest for clinicians
MDedge Family Medicine
Will changing the names of psychiatric medications lead to better treatment?
MDedge Family Medicine
Pimavanserin reduced dementia-related psychotic symptoms without affecting cognition
MDedge Family Medicine