Germany. The Federal Institute for Drugs and Medical Devices has recommended to marketing authorization holders of laxative products containing phenolphthalein that they renounce their marketing authorizations for these products in view of the latest findings regarding the potential toxicological risks associated with this compound.
[See also Pharmaceuticals Newsletter No. 10, October 1996 and Alert No. 65 dated 7 October 1997]
Reference: Info Fax Pharmacovigilance, Federal Institute for Drugs and Medical Devices, Berlin, 15 October 1997.