FDA Panel Recommends Label Changes to Reduce Risk of Problems from Fosamax
Labels on bisphosphonates, a type of medication used to treat and prevent osteoporosis, should further clarify how long patients can take them, an FDA advisory panel voted today. The FDA convened the meeting because of emerging safety concerns related to long-term use — generally considered more than three to five years — of bisphosphonates. Bisphosphonates include Aclasta, Actonel, Altevia, Boniva, Fosamax, and Reclast. Four million to 5 million Americans fill prescriptions for the drugs every year, according to the FDA. The panel, made up of the Advisory Committee for Reproductive Health Drugs and the Drug Safety and Risk Management Advisory Committee, voted 17 to 6 in favor of recommending additional labeling information about the drugs’ long-term safety and effectiveness. The panel left how those warnings should be worded up to the FDA. While the federal drug regulatory agency is not required to follow the advice of their advisory panels, it is usually heavily influenced by the recommendations. New label information would likely warn users about the reduced benefits from Fosamax and other bisphophonates after they have been taken for several years, and the potential risk of serious and debilitating injuries that could result as the medications build up in the body over a number of years. According to documents released in advance of the panel meeting, some FDA staffers strongly believe that a five year time limit should be placed on taking the drugs, indicating that women get the most benefit in treating osteoporosis during the first three years on the medications.