FDA Warns Untreated Constipation From Clozapine Use Can Lead to Serious Bowel Complications

The FDA on Tuesday issued anupdated warning that constipation caused by the antipsychotic clozapine may increase the risk of serious bowel complications in some patients.Constipation is already an identified side effect of clozapine, but “serious and fatal events continue to be reported,” according to the FDA’swebsite. The medication affects how the intestines function in most patients, and an uncommon but serious problem is complete blockage of the bowel. The risk is greater with clozapine compared with other schizophrenia medications, the FDA wrote.Higher doses of clozapine and the use of clozapine in combination with anticholinergics and/or other medications known to cause constipation, including opioids, can further increase this risk, the agency warned.The FDA reviewed cases from 2006 to 2016, some of which were reported to the agency ’s Adverse Event Reporting System while others were identified through medical literature in the same time period. They identified 10 cases involving constipation “that resulted in hospitalization, surgery, and five deaths.” The total daily dose of clozapine in these cases ranged from 200 mg t o 600 mg, and the time to onset of serious bowel events ranged from three days to six months.The adverse events “included death of the colon wall (necrotizing colitis), blockage of blood flow to the intestines (intestinal ischemia), death of part of the intestine (intestinal necrosis), and abdominal distention leading to bowel obstructio...
Source: Psychiatr News - Category: Psychiatry Tags: anticholinergic antipsychotic bowel complications clozapine constipation FDA FDA MedWatch program Food and Drug Administration warning Source Type: research