Monday, September 12, 2011

Osteoporosis Drugs Must State How Long Patients Should Take Them

Osteoporosis drugmakers must clarify how long patients should take the popular treatments in order to prevent harmful side effects, advisers to the Food and Drug Administration voted Friday.

The drugs are known as biphosphonates, and include bestsellings brands osamax, Boniva, Actonel, Atelvia and Reclast. The FDA itself will determine later whether they will be required to state how long patients should take each drug, but it's still unclear how long that might be.

According to the FDA, in 2009 more than 5 million prescriptions were filled for bisphosphonates, which reverse dangerous thinning of bones, preventing hip and spine fractures that cause pain and can result in serious health problems and hospitalizations.

At the meeting Friday in Adelphi, Md., a panel of advisers to the FDA reviewed details of several studies. A few patients have suffered serious complications, including jawbone destruction, unusual thighbone fractures and cancer of the esophagus after several years of taking the medications, and some have sued the drugs' makers.

Dr. Elizabeth Shane, past president of the American Society for Bone and Mineral Research, told HealthDay that side effects like atypical fractures and osteonecrosis of the jaw are "extremely rare, when considered in the context of how many people take bisphosphonates for osteoporosis." She was "less certain about the esophageal cancer issue...but when you consider the number of very dangerous, life-threatening fractures that are prevented by these drugs, the benefits dwarf the side effects," Shane, a professor of medicine at Columbia University, told reporters.

"I am really not in favor of putting a limit on use of bisphosphonates and dictating the use of drug holidays," Shane said.