We should wait at least seven years from when the Food and Drug Administration approves a new drug, the organization says.
It made this point generally in its book, Worst Pills, Best Pills, which I reviewed here a couple of years ago. The key recommendation in that book is not to use a new drug for seven years after the FDA approves it, except for rare breakthrough drugs. Public Citizen set forth its reasoning for this recommendation in a 2002 article that JAMA, the journal of the American Medical Association, published.
Now, Public Citizen urges people to refrain from using Januvia until 2014, seven years after the FDA approved it in October 2006. People who took part of clinical trials of Januvia had higher levels creatinine, which are often an early indicator of kidney problems.
The organization doesn’t think that Januvia is any sort of breakthrough, either. It quotes the FDA medical officer for Januvia as saying that its effect on reducing A1C was “fairly modest.”
Public Citizen bases the “Seven Year Rule” on its findings that in the first two years after the FDA approves a new drug half of them get drug safety warnings. And half of the so-called black box warnings – the FDA’s most severe warning – get slapped on new drugs within seven years of the time the FDA approves them.
It looks more and more like it makes sense for us to generally wait seven years in the wake of the growing concern over Avandia and Actos. It was almost exactly seven years ago that the FDA approved both of them. Just last week the agency announced that it would require black-box warnings on both of those drugs because of their heightened risk of heart attacks.
It’s clear that many doctors will now look around for alternative diabetes drugs to prescribe as the fear of taking Avandia or Actos grows. Except for the Public Citizen warning, my guess is that many of them would turn to the newest kid on the block, Januvia. But maybe not now.