January 1, 1970 · FLEMING | NOLEN | JEZ, L.L.P.
Per the New York Times, two advisory panels of the F.D.A. will consider the safety of Fosamax and other bisphosphonates which are used to combat osteoporosis and osteopenia.
The panels will meet Friday in Maryland and are expected to address two principal questions: 1) Whether the drugs have been proved safe to use, 2) Whether to restrict their use or require “drug holidays”.
In an article published last Thursday in the Cleveland Clinic Journal of Medicine, Dr. Susan Ott concluded that in most cases the drug should be stopped after five years. This is because the current studies were limited to five years and did not study the effects of Fosamax and similar drugs for longer periods of time. Some women may have been taking the drugs for as long as fifteen years.
The F.D.A. panel will hopefully address concerns that when bisphosphonates like Fosamax inhibit the bone resorption process, they actually cause the bone to become brittle and more susceptible to breaks. Whether “drug holidays” are enough to prevent injuries is an unknown because, as Dr. Ott’s article points out, there simply have not been enough studies done on the long term effects of bisphosphonates. Hopefully Friday’s meeting is a sign that the F.D.A. is taking seriously the dangers of under-tested drugs like Fosamax. An update will be available as soon as the panels release their reports.