Fibrosing colonopathy associated with cysteamine bitartrate delayed-release capsules in cystinosis patients.

ABSTRACT:

Background

The objective of this report is to identify and characterize cases of fibrosing colonopathy, a rare and underrecognized adverse event, associated with cysteamine delayed-release (DR) in patients with nephropathic cystinosis.

Methods

We searched the U.S. Food and Drug Administration Adverse Event Reporting System (FAERS) and the medical literature for postmarketing reports of fibrosing colonopathy associated with cysteamine through August 2, 2023.

Results

We identified four cases of fibrosing colonopathy reported with the use of cysteamine DR. The time to onset ranged from 12 to 31 months. In one case, the patient required surgery to have a resection of a section of the strictured colon and a diverting ileostomy. Fibrosing colonopathy was diagnosed by histop

SUBMITTER: Kishk OA 

PROVIDER: S-EPMC11199274 | biostudies-literature | 2024 Aug

REPOSITORIES: biostudies-literature