OTC laxatives
This article was originally published in The Tan Sheet
Executive Summary
FDA should deny C.B. Fleet's citizen petition to amend OTC laxative tentative final monograph requesting professional labeling for sodium phosphate oral solution, Braintree Laboratories says in recent comments to the agency. Fleet requested special warnings and directions for two 30 ml to 45 ml doses taken 10 to 12 hours apart (1"The Tan Sheet" Aug. 4, 2003, p. 12). However, Braintree maintains the studies presented by Fleet are flawed in part because they excluded individuals contraindicated to take the drug. "This is precisely the problem, where, due to its OTC status, there exists a perception of safety such that many practitioners are clearly unaware of the contraindication," the comments assert. Adverse events experienced by the study participants should be seriously considered, as those individuals are assumed to be the correct target population for the solution, Braintree adds...