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January 29, 2020
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FDA issues stronger constipation warning for clozapine

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The FDA issued a new safety communication announcing a strengthened warning about the risks of untreated constipation among patients who receive clozapine.

The agency will require new warnings and updates about this risk to be included with the prescribing information of all clozapine products.

Clozapine commonly causes constipation in patients, which if left untreated can lead to serious bowel complications including complete blockage of the bowel, according to the safety communication. The risk increases at higher doses and when the drug is used in combination with anticholinergics or opioids.

The FDA advised providers to evaluate patient bowel functions prior to prescribing clozapine and to avoid prescribing it with other medications that can slow motility. Additionally, the agency advised patients to contact their doctors if their bowel movements are less frequent than normal or if they have difficultly passing gas.

Reference:

www.fda.gov