New FDA Drug Safety Communication on clozapine (Clozaril, Fazaclo ODT, Versacloz)

https://www.fda.gov/drugs/drug-safety-and-availability/fda-strengthens-warning-untreated-constipation-caused-schizophrenia-medicine-clozapine-clozaril-can?utm_campaign=New%20Drug%20Safety%20Communication%20on%20clozapine%20%28Clozaril%2C%20Fazaclo%20ODT%2C%20Versacloz%29&utm_medium=email&utm_source=Eloqua


New FDA Drug Safety Communication on clozapine (Clozaril, Fazaclo ODT, Versacloz)

The Food and Drug Administration (FDA) is strengthening an existing warning that constipation caused by the schizophrenia medicine clozapine (Clozaril, Fazaclo ODT, Versacloz, generics) can, uncommonly, progress to serious bowel complications. This can lead to hospitalization or even death if constipation is not diagnosed and treated quickly. Constipation is a frequent and known side effect of clozapine, but serious and fatal events continue to be reported. Clozapine affects how the intestines (bowels) function in the majority of patients. It produces effects ranging from constipation (trouble having a bowel movement), which is a common occurrence, to serious but uncommon bowel problems, including complete blockage of the bowels. We found that because of the way clozapine works this risk is greater with clozapine than with the other schizophrenia medicines in its drug class. The risk is further increased at higher doses of clozapine and when it is co-prescribed with a type of medicine called anticholinergics, which can slow the movement in the intestines, and other medicines that cause constipation, including opioids. Many different kinds of medicines have these anticholinergic effects. We are requiring a new warning and updates about this risk to be added to the prescribing information of all clozapine products. As part of FDA’s routine monitoring, we will continue to monitor clozapine and will report updated information to the public if it becomes available. Patients may not feel or be aware of constipation symptoms. However, you should contact your health care professional if your bowel movements are less frequent than normal for you, especially if you do not have a bowel movement at least three times a week, you have hard or dry stools, or you have difficulty passing gas. You should contact your health care professional right away if you have symptoms that can be associated with serious bowel problems such as nausea and vomiting, bloating or belly swelling, or belly pain. Health care professionals should evaluate bowel function before starting a patient on clozapine and avoid co-prescribing clozapine with other anticholinergic medicines that can cause gastrointestinal hypomotility. Advise patients frequently of the significant risk of constipation and life-threatening bowel issues and the need to stay hydrated to prevent constipation.

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