Label change expected for osteoporosis drugs Fosamax, Actonel and Boniva

A US FDA advisory committee wants the health agency FDA to limit the duration of bisphosphonate therapy for treatment of osteoporosis. The panel could not agree on what that time limit should be. The panel also endorsed a label change for osteoporosis drugs.

Earlier this year, the FDA required that all bisphosphonates used to prevent or treat osteoporosis warn on their labels that optimal duration of use hasn’t been determined, and that all patients on bisphosphonate therapy should have their need for continued therapy re-evaluated periodically.

The Advisory Committee for Reproductive Health Drugs and the Drug Safety and Risk Management Advisory Committee met to discuss whether emerging reports of adverse events should spur the FDA to change the label to indicate that the drug not be used long term, and the committee members voted 17-6 to endorse a label change — but then backed away from setting a hard deadline.

Panelists repeatedly raised concerns that they did not have enough evidence to come up with specific suggestions or conclusions, and some recommended raising awareness of such uncertainties in the label as well.

The drugs under review include Merck & Co’s (MRK.N) Fosamax, Warner Chilcott’s (WCRX.O) Actonel, Roche’s (ROG.VX) Boniva and Novartis’ (NOVN.VX) (NVS.N) Reclast. This class of drugs has also been linked to osteonecrosis of the jaw, or jaw bone death, and a possible higher cancer risk.

Studies presented by the FDA and the industry did not paint a conclusive picture to estimate whether benefits outweigh the risks in taking bisphosphonates for longer than three to five years or how exactly each of these drugs affects various subgroups of patients, advisers said.

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The FDA is expected to issue a revised label in November for the drugs, known as bisphosphonates, including Fosamax, Actonel and Boniva.

Source: U.S. Food and Drug Administration, USA

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