Should patients who take medications such as Fosamax and Boniva to strengthen their bones go on a “drug holiday” after a number of years to avoid potentially harmful side effects?
Scientific advisers to the Food and Drug Administration who took up that question last week failed to come up with an answer. The experts, from two FDA advisory panels, said more research is needed on the safety of the class of drugs known as biphosphonates. They are widely prescribed to prevent hip and other fractures related to osteoporosis.
The only action taken Friday was a 17-to-6 vote calling for the drugs’ labels to be rewritten to reflect uncertainty about the risks and benefits of long-term use of the medications. But there was no consensus among the panelists on how the wording should be changed.
As Reuters reports, since Fosamax became the first bisphosphonate to get FDA approval for osteoporosis in 1995, the labels for the drugs have undergone various revisions regarding possible side effects.
In 2005, a warning of a higher risk of a rare affliction of the jawbone was added to labels. Later warnings were added about gastrointestinal reactions and unusual fractures of the femur, or thighbone. Scientists also are looking into a possible link with esophageal cancer.
FDA staffers, in briefing materials for Friday’s meeting of the two expert panels, said that existing research has found that patients don’t benefit from taking the drugs beyond five years. The expert panelists, however, didn’t find that the available research provided conclusive answers about the benefits or risks of long-term use of the drugs, so they avoided deciding whether patients should take a drug holiday.
STUART SILVERSTEIN
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I broke my femur several years ago. They definitely need to figure this out before giving out more bad drugs. You read my recovery at femurfractureguide.com.