Jan 28,2020: FDA is underpinning an existing warning that constipation caused by the schizophrenia medicine clozapine (Clozaril, Fazaclo ODT, Versacloz, generics) can, unusually, progress to serious bowel complications. This can lead to hospitalization or even death if the constipation is not diagnosed and treated quickly.
Background: Clozapine affects how the intestines (bowels) function in the widely held patients. It produces effects ranging from constipation (trouble having a bowel movement), which is a frequent incident, to serious but unusual bowel problems, including complete blockage of the bowel.
Recommendation: Patients should contact to their health care professional if:
- Their bowel movements are not as much than normal.
- Not have a bowel movement for at least three times a week.
- Have hard or dry stools.
- Have difficulty passing gas.
- Patients should contact your health care professional immediately if you have symptoms which can be associated with the serious bowel problems such as: nausea, vomiting, bloating or belly swelling, or belly pain.
Health care professionals should:
- Evaluate the bowel function before starting the patient on clozapine.
- Avoid co-prescribing clozapine with other anticholinergic medicines (cause gastrointestinal hypomotility).
- Advise patients frequently of the significant risk of the constipation and life-threatening bowel issues and the need in order to stay hydrated to prevent constipation.
- Question patients concerning the frequency and quality of their bowel movements throughout treatment.
Healthcare professionals and patients are encouraged to account adverse events or side effects related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program. https://fda.einnews.com/pr_news/508279977/clozaril-fazaclo-odt-versacloz-clozapine-drug-safety-communication-fda-strengthens-warning-that-untreated-constipation-can-lead-to-serious
