FDA elaborates on Visicol seizures

Executive Summary

FDA publishes "1Science Backgrounder" on Visicol-induced seizures on agency website following meeting with InKine execs. Company expressed concern that an FDA letter published in the June 27 New England Journal of Medicine "misstated or omitted" several facts about four seizures reported with use of Visicol, which is indicated for bowel cleansing before colonoscopy. In the website backgrounder, FDA clarifies per InKine's request that more than 210,000 patients have received Visicol (sodium phosphate) and no seizures had been reported since August 2001, although agency notes "there is generally under-reporting of adverse events." Backgrounder also notes that OTC sodium phosphate-containing products have been associated with three seizure reports in the published literature, although they have not been reported to FDA. InKine published a response to the NEJM letter in the online version of the June 27 publication; the response will also appear in the printed July 25 issue...