Senna Safety To Be Studied By Purdue, Madaus, Novartis, Reckitt & Colman
This article was originally published in The Tan Sheet
Executive Summary
Laxative product manufacturer Purdue Pharma (Senokot) is working with Madaus AG (Agiolax), Novartis Consumer Health (Ex-Lax) and Reckitt & Colman (Senokot overseas) to "comparatively analyze" natural senna as well as sennoside laxative active ingredients, Purdue told FDA in a June 30 letter made available recently. The firm had agreed to conduct a two-year safety study on the laxative ingredient in a Sept. 3 letter to the agency (1"The Tan Sheet" Sept. 28, 1998, In Brief).
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Purdue Pharma
Elects to conduct a two-year safety study on senna in support of the ingredient as a Category I OTC laxative ingredient. FDA had called for more data on senna in the June 19 Federal Register ("The Tan Sheet" June 22, p. 6). Purdue outlines its proposed carcinogenicity study in rats in a Sept. 3 letter to the agency, noting it already has completed the in-life phase of the preliminary dietary acceptance/intubation feasibility study and two-week oral range-finding toxicity study in the rat. NDMA has asked the agency keep the administrative record for OTC laxatives open until safety studies on both senna and bisacodyl are completed
Bisacodyl, senna OTC laxative safety data requested by June 1999 in FDA proposal.
BISACODYL, SENNA OTC LAXATIVE SAFETY DATA REQUESTED BY JUNE 1999 in an FDA proposed rule published in the June 19 Federal Register. As expected, the proposal tentatively reclassifies senna, bisacodyl, cascara sagrada and aloe from Category I (safe and effective) to Category III (further testing needed) in the tentative final monograph for OTC laxatives and reopens the administrative record for data considered necessary to establish the safety of the ingredients.