Tell the FDA to Stop Preventive Use of Bisphosphonates that Causes Loss of Bone Mineral Density

I’m writing today to ask you to help the National Women’s Health Network (NWHN)
deliver an important message to the Food and Drug Administration (FDA) about
drugs prescribed to prevent osteoporosis, known as bisphosphenates. It’s
time to let the FDA know that women want evidence that these drugs actually
work and are safe before they are sold!

Bisphosphonates are approved for both treatment and prevention of osteoporosis.
While the NWHN has questions about long-term use of bisphosphonates for
treatment, what we’re most concerned about today is that many healthy women
are taking these drugs today in the hopes that it will keep them healthy in
spite of evidence showing it can cause serious harm.

The FDA approved bisphosphonates for prevention, despite the NWHN’s serious
concerns, based on evidence that the drugs reduce loss of bone mineral density
(BMD), rather than evidence that they actually prevent fractures. A
woman’s BMD naturally decreases with age, and a BMD test does not predict
whether her bones will actually fracture, but women are taking bisphosphonates
simply because they have lower BMD levels than they did when they were
younger. Now, thanks to the research we asked the FDA to require
companies that make these drugs to do, we have data showing that using
bisphosphenates for longer than three to five years increases the risk of thigh
fractures, serious damage to the jawbone and esophageal cancer. That means
a healthy woman who takes bisphosphonates for several years to prevent
fractures based only on a BMD test is being exposed to serious risks in the
hopes of preventing fractures that she may never have experienced anyway!

With this new evidence, the NWHN has called on the FDA to reverse the decision
to approve bisphosphonates for prevention of osteoporosis. Please add
your voice to ours and tell the FDA that it should stop allowing the use of
these drugs on healthy women.

And the problem is bigger than this one kind of drug — this experience also
shows that the FDA has been misguided in approving osteoporosis drugs for
prevention without evidence that the drug will prevent fractures. Just
two weeks ago, when an FDA advisory committee met to evaluate another kind of
osteoporosis drug, several committee members said that BMD is no longer
considered a proven standard for assessing fracture risk. They agree with
us that women need better evidence that osteoporosis drugs will prevent
fractures before the FDA approves them!

We at the NWHN are working hard to make sure women have safe and effective
options for maintaining healthy bones as they age, including keeping products
that are unsafe or don’t work off the market and you can help! Click
here to tell the FDA to stop preventive use of bisphosphonates and require
evidence of real fracture prevention before approving another drug for this
use.

Thank you,


Cindy Pearson

Executive Director