Manufacturers of bisphosphonate drugs such as Fosamax and Zometa should make changes to their product labeling to reduce the risk of bone fractures, two U.S. Food and Drug Administration (FDA) advisory panels concluded Friday.
The outside advisors to the FDA met to review the potential risks associated with long-term use of bisphosphonate medications and to determine whether these drugs are safe and effective when used longer than three to five years.
The panel members voted 17-6 in favor of bisphosphonate drug manufacturers clarifying on their packaging the length of time that osteoporosis patients should take the medications, according to a report by Bloomberg.
The FDA is not required to follow its panels' recommendations, Bloomberg noted.
Bisphosphonate drugs such as Fosamaxhave been used for more than 15 years to reduce the risk of fractures associated with osteoporosis. But long-term use has been linked to osteonecrosis of the jaw (ONJ), which in turn has led to hundreds of lawsuits being filed against Merck, the maker of Fosamax, and Novartis Pharmaceuticals, the maker of Zometa.
More than 1,000 cases are pending against Merck and Novartis, all involving allegations that the drug makers failed to adequately warn about the risk of ONJ associated with their bisphosphonate drugs. A few of the cases have so far gone to court, with mixed results.
In 2009, a Montana jury awarded $3.2 million to a woman who sued Novartis, but in 2010 the company triumphed in a subsequent case.
In 2010, Merck was ordered to pay a 72-year-old plaintiff $8 million in compensatory damages after a jury concluded that the woman's use of Fosamax caused her to develop ONJ and related dental problems. That amount was later reduced to $1.5 million. Another case against Merck was thrown out in 2009, while another jury found in favor of Merck in a case decided in May 2010.
The FDA announced in July that it was continuing to review data from published studies to evaluate whether the use of oral bisphosphonates is associated with an increased risk of esophageal cancer, unusual breaks of the femur, or ONJ.
