Adverse Effects of Sulindac Used for Prevention of Colorectal Cancer

Extract

Many intervention trials for colorectal cancer in familial adenomatous polyposis (FAP) have been conducted all over the world. Many of these trials have consisted of the administration of nonsteroidal anti-inflammatory drugs (NSAIDs) to reduce the size and number of adenomatous polyps. Use of NSAIDs has produced complete regression of the polyps in some cases ( 1 , 2 ). In studies in western countries, severe complications developing as a consequence of administration of NSAIDs have not been reported so far ( 3 ), despite the generally accepted opinion that NSAIDs can cause gastrointestinal complications. In our study in Japan, however, severe adverse effects were recognized with considerable frequency. Therefore, we thought they should be reported to alert the medical community to the possible toxic effects of NSAIDs.

Three years ago, we started a clinical intervention trial for patients with FAP and with multiple adenomatous polyps. We planned to treat the patients with sulindac, one of the NSAIDs, to prevent colorectal cancer. This study was approved by an ethics committee of our institute. The six case subjects gave informed consent; five of them had FAP, and the remaining one had more than 30 colorectal adenomatous polyps. We treated the patients on a protocol of sulindac (300 mg/day) and subsequently examined them by total colonoscopy every 6 months.