Bone-strengthening drugs such as Merck & Co. (MRK)’s Fosamax, used to treat and prevent osteoporosis in older women, may have little long-term benefit, U.S. regulators said in an analysis of previously released studies.
Research from the Food and Drug Administration, published yesterday in the New England Journal of Medicine, renews a debate about whether use of the drugs after more than three to five years provides any protection against the risk of bone fractures. The agency has been evaluating the safety of the treatments since 2007 and last September an advisory panel suggested changes to the medicines’ labels to show the effectiveness may wear off over time.
About 8 million women and 2 million men in the U.S. have osteoporosis and 34 million Americans have low bone mass that puts them at risk of the disease, according to the FDA. The agency previously linked the drugs, which include Warner Chilcott Plc (WCRX)’s Actonel and Roche Holding AG (ROG)’s Boniva, to thigh fractures and jawbone deterioration. It is also investigating conflicting studies that the treatments may raise the risk of esophageal cancer.