Warner Chilcott, PLC, Merck & Co., Inc. Bone Drugs Need Label Changes on Use Duration, Panel Says
Published: Sep 12, 2011
Bone drugs from Warner Chilcott Plc (WCRX), Roche Holding AG (ROG), Merck & Co. and Novartis AG (NOVN) need labeling changes to reduce the risk of fractures, a U.S. panel said. The FDA should call for clarifications on the length of time that osteoporosis patients should take the medicines, outside advisers to the Food and Drug Administration said today in a 17-6 vote in Adelphi, Maryland. The FDA isn’t required to follow its panels’ recommendations. The agency has evaluated the safety of the drugs, known as bisphosphonates, for almost four years and cited possible links to unusual thigh fractures and jawbone deterioration in 2010. The drugs are taken most often by post-menopausal women who have osteoporosis. The agency said in July it also was examining conflicting studies on whether bisphosphonate pills such as Warner Chilcott’s Actonel, Merck’s Fosamax and Roche’s Boniva raise esophageal cancer risks.