Senna and carcinogenicity
This article was originally published in The Tan Sheet
Executive Summary
Purdue Pharma will amend and submit its final report on a two-year oral carcinogenicity study in rats to support the safety of senna-containing OTC laxatives by end of March 2004, company states in recent letter to FDA. Agency requested the completion of histopathological examinations of the brain tissues from the remaining animals of the low- and mid-dose groups in an Oct. 21. letter to the company. Purdue will evaluate 33 rats in its follow up examination. "It must be noted that the protocol for this study was reviewed and accepted by the Carcinogenicity Assessment Committee [and] this additional analysis was not required according to the protocol," Purdue states in the letter...