FDA says bone drug benefits exceed risks for now
Regulatory
BANGALORE (Reuters) - U.S. health regulators on Thursday backed a class of osteoporosis drugs that have been linked to higher risk of cancer and said at this time they believe the drugs' benefits outweigh potential risks.
The U.S. Food and Drug Administration is currently reviewing data from published studies to evaluate whether use of oral bisphosphonates is associated with an increased risk of esophageal cancer and has not reached any conclusions.
The FDA said there were conflicting data on the risk and insufficient data to recommend endoscopic screening of asymptomatic patients.
A British study last year found that people taking the drugs for more than five years may be doubling their risk of developing esophageal cancer.
Oral bisphosphonates are widely used for the prevention and treatment of osteoporosis as well as to treat other bone diseases.
The drugs include Merck's Fosamax, Warner Chilcott's Actonel, Atelvia and Didronel, Roche's Boniva, Sanofi's Skelid, Novartis' Aredia, Zometa and Reclast.
