Actonel Label Gets Warning on Severe GI Irritation

Procter & Gamble has revised the labeling for its osteoporosis drug Actonel to warn of severe gastrointestinal (GI) irritation associated with bisphosphonate products, which are used to prevent bone loss. Gastrointestinal irritation is a class effect and other bisphosphonate makers are revising their labels, FDA spokeswoman Karen Mahoney said. Those drugs include Merck’s Fosamax (alendronate sodium) and GlaxoSmithKline’s Boniva (ibandronate sodium), she added.
Drug Industry Daily