FDA Panel Endorses New Label Risk Language For Fosamax®

While Friday's panel vote is advisory only, and while the panel could not agree on the cut-off point for duration of Fosamax^® therapy, the panel did note that there is no evidence of additional efficacy beyond three years.

As has become the de facto accepted best-practice presecribing pattern since at least mid-2010 -- at least in those patients who are not suffering the very worst cases of osteoporosis -- the FDA advisory panel made favorable comments about putting Fosamax patients (the vast majority, by numerosity) on extended "drug holidays", after a period of time on the drug. The difficulty is that the panel could not source any reliable data as to how long the period should be, nor how long the "drug holiday" period ought to be.

Still, this panel vote is an important move toward reversing the prior (largely Merck-) marketing-driven mantra -- "once a senior citizen is prescribed Fosamax, they'll take it until the day they die. . ."

Many experts are now saying, and offering evidence that for most patients, that is no longer a wise -- or safe -- approach. Here is some of the Reuters coverage of the vote:

. . . .U.S. health advisers declined to suggest how long women should take a class of drugs used by millions to prevent bone fractures, but agreed the labels should be changed to reflect uncertainty about the risks and benefits of long-term use.

The Food and Drug Administration had asked two of its advisory panels to recommend whether a "drug holiday" or some time limit was warranted on a class of osteoporosis drugs known as bisphosphonates that have been linked to unusual thigh fractures and other side effects.

Instead, the advisers voted 17-6 on Friday to make changes to the labeling with many in favor of specifying how often patients need a re-evaluation of whether they need the medicine.

Panelists repeatedly raised concerns that they did not have enough evidence to come up with specific suggestions or conclusions, and some recommended raising awareness of such uncertainties in the label as well. . . .

The drugs under review include Merck & Co's Fosamax, Warner Chilcott's Actonel, Roche's Boniva and Novartis' Reclast. This class of drugs has also been linked to osteonecrosis of the jaw, or jaw bone death, and a possible higher cancer risk.

Studies presented by the FDA and the industry did not paint a conclusive picture to estimate whether benefits outweigh the risks in taking bisphosphonates for longer than three to five years or how exactly each of these drugs affects various subgroups of patients, advisers said.

"I'm used to dealing with ambiguity in a clinical setting, but this raises it to different heights," said Brian Erstad, pharmacy professor at the University of Arizona and a member of the drug safety and risk management advisory panel. . . .

Now that Secrest bellwether case (in Manhattan's federal District courthouse) has an empaneled jury, both sides are ready to present opening arguments, come Monday morning. Indeed, I am sure we will have updates on these very Fosamax topics through the end of September, when, it is thought, the Secrest case will be given to the jury, for a decision. Do stay tuned.