FDA Panel Waffles on Limiting Duration of Bisphosphonate Use

 

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Taken together, there's no clear answer on the long-term safety of bisphosphonate therapy for the prevention and treatment of osteoporosis, the panel said and called for more studies to hone in on the long-term risks and benefits of the drug.

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"There's no doubt that these are very efficacious drugs that reduce fractures and mortality, and there are many women who should be on these drugs that aren't on them," said Dr. Sonia Hernandez Diaz, associate professor of epidemiology at Harvard School of Public Health. "But what we're talking about today is using these drugs for more than three years, and I'm not convinced at all that there are any good data that, even for subgroups of patients, they should be continued [past three years]."

The panel was also asked to discuss the idea of a "drug holiday" or taking a break for bisphosphonate treatment in order to minimize risks, but agreed there wasn't enough evidence to warrant recommending a drug holiday as a treatment plan.