Friday, July 22, 2011
Boniva: Increased Risk of Esophageal Cancer?
Boniva, the once/month osteoporosis medication manufactured by Genentech and prescribed to primarily women (men get osteoporosis, too) is under investigation by the FDA. A British study links Boniva to an increased risk of esophageal cancer. Merck's Fosamax is being evaluated for fractures that may be associated with that drug. Forums on osteoporosis report issues with necrosis of the jawbone, teeth and throat irritation, and femur fractures as early as 2006, with all the brand names cited. So, in 2011, the FDA gets around to looking. The FDA guidelines for drug approval to treat osteoporosis require clinical documentation of improvement or reduction in spinal vertebrae fractures only. And the original approval was for daily oral doses, which are no longer recommended. Injecting Boniva may have been the pharmaceutical company's bid to work around troubling diagnosed throat issues. FDA allowed bridge studies (not full clinical trials) for the once/month level of dosing. Please keep this in mind before seeking or accepting a prescription for any of these bisphosphonate meds, just because you're postmenopausal. There is evidence that improving your bone density with enriching diet, calcium, Vitamin D and exercise is just as effective as these drugs. Be an informed, safe woman consumer always.