FDA panel: change bisphosphonate labels

An FDA advisory panel voted 17-6 on Friday to recommend adding further clarification on the duration of use for bisphosphonates to treat osteoporosis in the products' labels. Although panelists who voted to change the labels did not reach consensus on specific recommendations, they felt that over time the drugs' efficacy might diminish and risks might increase. All panelists agreed that there are not enough long-term data available to limit duration of use to a specific time frame. The drugs' labels say "the optimal duration of use has not been determined."

Many panelists also said that labeling should be changed to recommend patients have their need for continued therapy reevaluated every year or two; the current labeling recommends such reevaluation "on a periodic basis." The panel comprised members of FDA's Reproductive Health Drugs and Drug Safety and Risk Management advisory committees. ...