FDA reviewing bisphosphonate esophageal cancer signal

FDA said it is reviewing the safety of oral bisphosphonates to determine whether use of the osteoporosis drugs are associated with an increased risk of esophageal cancer. The agency said there are conflicting findings from studies evaluating the risk: one epidemiological study found no increase in risk, while another found that the risk doubled in patients who had 10 or more prescriptions of the drugs, or who had taken bisphosphonates over three years. Both of those studies used the U.K. General Practice Research Database (GPRD). FDA said other researchers using different databases did not find an increased risk, or reported a decreased risk of the cancer. The agency did say it believes the benefits of oral bisphosphonates in reducing the risk of fractures in osteoporosis patients continue to outweigh the potential risks.

FDA's Reproductive Health Drugs and Drug Safety and Risk Management advisory committees are scheduled to meet on Sept. 9 to discuss the risks and benefits of bisphosphonates for long-term use to treat and prevent osteoporosis. The agency said long-term use may be associated with osteonecrosis of the jaw and atypical fractures of the thigh. ...