Recently the FDA requested two of its clinical research committees to determine whether bisophosphonate osteoporosis drug efficacy would benefit from a “drug holiday” in light of concern over the surfacing of unusual side effects. The drugs such as Merck’s Fosamax, Roche’s Boniva, Warner Chilcott’s Actonel and Novartis’ Recloct, are designed to prevent or reduce the impact of osteoporosis in post menopausal women, but there have been disturbing cases surfacing of unusual femur fractures and bone necrosis in jaws related to long term use.
There is some evidence that there is little beneficial contribution of the drugs beyond three to five years. The FDA was interested in receiving a recommendation as to whether it should impose a “drug holiday” after a period of time because of the shifting of the risk/benefit ratio with continued use. There are about 1,115 suits so far against the drug companies for jaw damage and 535 cases related to femur factures. The two committees, the Advisory Committee on reproductive health and Drug Safety and Risk Management Committees met jointly to consider the evidence. The committees were unable to find sufficient evidence to support the benefit over risk of a “drug holiday.”
Instead they recommended the development of a stronger warning. Perhaps this ambivalence will provide a market opening for Amgen’s new osteoporosis drug, Prolia, which is not a bisophosphonate.
In any event, Fosamax class action lawsuits are proceeding apace in New York with Merck winning two and losing a third in an 8 million dollar verdict.