The New York Times recently reported that a FDA committee has advised improving bone-building drug labels. The brands that will be affected are Actonel, Atelvia, Boniva, and Fosamax. Tens of thousands of women in Atlanta take such medications.
The advisory committee’s recommendation follows studies that suggest there is no noteworthy benefit of continuing such therapy past five years. Though the benefits of taking bone-building drugs for three to five years have been proven, such drugs have not been proven for long-term use.
The advisory committee assembled due to concerns that many women have suffered atypical thigh fractures or jaw disease after taking the medications long-term. However, none of the members of the committee advised imposing strict limits on long-term use. Neither did the committee recommend a black box warning even with petitions from former patients present.
A district judge determined that a plaintiff could continue her claim that the bone drug caused her jaw tissue to die. However, he advised her that no jury would settle in her favor over allegations that the drug maker didn’t adequately caution patients about the risks involved.