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An FDA advisory panel on Friday voted 17-6 in favour of recommending that the labels of bisphosphonates be updated to clarify how long patients should take them in order to reap the greatest benefit and least risk. The agency is expected to determine the wording for the revised labels in November.
Panelist Lewis Nelson noted that the new labels should "be very clear that efficacy may fall off after a period of time, perhaps five years." He added that "serious concerns have been raised about risk, and those need to be continually evaluated as well." However, the panel said there were not enough data beyond the three- to five-year time frame to draw conclusions or to suggest long-term treatment recommendations.
In documents released ahead of the panel vote, agency staff noted that the atypical fractures of the thigh, which were the subject of an October safety communication by the FDA, "appear to have a strong association with bisphosphonates, although causality has not been determined." However, the review noted that "there is no agreement on the extent to which cumulative use of bisphosphonates increases the risk" of these types of fractures.
Theresa Kehoe, an FDA clinical team leader, commented that the US regulator is re-assessing whether biphosphonate drugs should remain authorised to prevent osteoporosis, but noted the products are "highly effective" for treating the disease.
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