FDA Considers Sodium Picosulfate For OTC Laxatives Monograph Inclusion
This article was originally published in The Tan Sheet
Executive Summary
FDA has announced a call for data for safety and effectiveness information on sodium picosulfate up to 10 mg as a laxative single active ingredient
You may also be interested in...
Aloe, Cascara Sagrada Safety In Laxatives Still Needs Supporting Data – FDA
Data on aloe and cascara sagrada from the German Commission E monographs, World Health Organization reviews and the National Toxicology Program are insufficient to support the safety and efficacy of the ingredients in OTC laxatives, FDA concludes in a July 3 letter to the American Herbal Products Association
Phenolphthalein Banned In OTC Laxatives Effective Jan. 28
FDA's final rule banning the use of phenolphthalein in OTC stimulant laxatives based on safety concerns was published in the Jan. 28 Federal Register. The rule is effective immediately.
American Liver Foundation Issues Warning On Acetaminophen Intake Levels
Advisory follows recent JAMA study finding that maximum recommended OTC intake resulted in elevated liver enzymes for some participants.