The U.S. Food and Drug Administration (FDA) meeting over the use of drugs for osteoporosis and related conditions indicated it might want the duration of treatment limited, but couldn’t agree on a timeline. The class of drugs is called bisphosphonates and the FDA advisory committee was supposed to come up with some direction after data showing long-time use of bisphosphonate therapy can lead to atypical fractures and jaw bone death. Meeting Friday, September 9, the advisory committee voted 17-6 to endorse a label change but what that should include panelists were uncertain about.
Bisphosphonates are prescribed to about five million Americans to prevent bone mass loss. Some of the common brand-names are Actonel, Atelvia, Boniva, Fosamax, and Reclast. The panel heard from women who heard their femur snap suddenly and unexpectedly after they had been on bisphosphonates for some time. In 2005, the FDA added a warning about a rare osteonecrosis where the jaw bone dies. That may occur after four years or more of taking the drug. There are also some reports of a link between the drug class and esophageal cancer.
It may make the most sense to take a “drug holiday” but panelists don’t agree whether that should occur after three years or sooner.
Farah & Farah’s products liability attorneys in Jacksonville remind us that if a drug is defective in its manufacture, in its design, or in labeling and a failure to warn, the patient who is harmed may be able to receive compensation for medical costs, rehabilitation, pain and suffering, and lost wages. #
Source: http://www.medpagetoday.com/Endocrinology/Osteoporosis/28442#ayk
