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FDA Advisers Call for Revised Labels for Osteoporosis Drugs
Date:9/9/2011

While these side effects shouldn't be downplayed, "when you consider the number of very dangerous, life-threatening fractures that are prevented by these drugs, the benefits dwarf the side effects," said Shane, also a professor of medicine at Columbia University in New York City.

However, she said bisphosphonates should only be prescribed to those at the highest risk of fracture. "In the past we might have used them in people who aren't at such high risk of fracture in the hope that they would prevent fractures down the line," she said. "We have moved to targeting people at high short-term risk, which means in the next five to 10 years."

According to Shane, the absolute risk of developing osteonecrosis of the jaw is between 1 in 10,000 and 1 in 400,000 among people taking these drugs for osteoporosis.

But when high-dose bisphosphonates are used to slow the spread of bone cancer, the risk rises, affecting anywhere from 1 percent to 15 percent of patients, she said.

For atypical femur (thigh) fractures, the absolute risk linked to bisphosphonates is about 1 to 5 fractures in 10,000 bisphosphonate users, she said.

Besides hip fractures, bisphosphonates prevent spine, wrist and arm fractures, Shane said.

The FDA asked the advisory committee to consider whether current data support long-term use of bisphosphonates for treating or preventing osteoporosis. The experts also were to consider whether a time limit should be placed on the drugs' use, and if patients who need long-term therapy would benefit from a "drug holiday," meaning time off the medication.

"I am really not in favor of putting a limit on use of bisphosphonates and dictating the use of drug holidays," Shane said. "We have very little evidence to support the use of drug holidays or no drug holidays."

Dr. Nelson Watts, director of the University of Cincinnati Bone Health and Osteoporosis Center and co-author of a 2010 study on long-term use of bisphosphonate
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