The Food and Drug Administration (FDA) said Friday that labels certain osteoporosis drugs should be altered in order to better communicate long-term effects of the medications.
The Advisory Committee for Reproductive Health Drugs, working in consultation with the Drug Safety and Risk Management Advisory Committee, noted that the revised label should “be very clear that efficacy may fall off after a period of time, perhaps five years,” adding, “serious concerns have been raised about risk, and those need to be continually evaluated as well.”
While the group put forth the proposal for a label change, the panel also noted the lack of evidence supporting long-term effects directly related to the bone drugs. The federal advisory panel said Friday that there is not enough data to make recommendations about whether the use of the widely prescribed drugs should be limited.
Panel members were deeply split on the issue of whether to impose a drug “holiday,” citing the lack of evidence. Panel advisers voted 17 to 6 to make changes to the labeling, even as a number of panel members questioned exactly which changes should take plae.
The move comes as the FDA had requested two of its advisory panels to recommend whether a “drug holiday” or a limit on bone drugs was warranted. The FDA announced the panel’s formation in July, noting that it would convene a joint meeting of advisory committees on drug safety. Researchers have speculated that while the drugs do slow the breakdown of bone associated with aging, they might also make the remaining bone brittle and susceptible to the rare fractures and bone decay.
Worldwide sales of osteoporosis drugs were $7.6 billion last year, down from a peak of $8.8 billion in 2007. About 8 million women and 2 million men in the U.S. have osteoporosis, while 34 million Americans have low bone mass, placing them at risk of osteoporosis.
