FDA looking into bisphosphonate safety? Well it’s about time!

As I was heading to Maine for the weekend last Friday, two advisory panels of the Food and Drug Administration (FDA) were looking at whether or not it’s safe to take bisphosphonates (such as Fosamax) for more than five years.

Just a mere 15 years after the drugs became common.

If you sense more than a little frustration in the statement above, you are right.  Here’s why:

• While I obviously believe it is important for the FDA to tell consumers about the very real dangers of these drugs, I have to ask what took them so long — so long that there are many women who have been taking a drug for more than 10 years without any study of the safety or the risk! In fact, one drug manufacturer is facing more than 1,500 lawsuits regarding jaw damage or unusual femur fractures and other bone injuries.

• What’s more, there’s a lot of confusion around the effectiveness of these drugs. Research data reported by bone specialists such as Dr. Susan M. Ott has shown the benefits of bisphosphonate drugs are far less than people have been told. Gillian Sanson, in her wonderful book The Myth of Osteoporosis, spells out all of the statistics that show how ineffective these drugs really are, but I want to quote her on just one: “If a woman has low bone density (osteopenia), but no previous fractures, her risk for fracture is low. Any treatment is at best going to marginally reduce an already low risk.It is estimated that up to 270 such women would need to be treated for three years to prevent one vertebral fracture in one of them.” (Sanson, 2011, p. 81-2).

• I also have to wonder where we’re going with this.  Does this mean that we’re going to wake the “sleeping monster” of even stronger drugs such as Prolia? Meaning — will doctors and the pharmaceutical industry cast it as a “new, safer drug” and just switch people to a new drug?

Now, there’s also very good news about the FDA investigation.  In particular, I want to celebrate:

• The news is getting out to more people than ever that bone drugs can cause serious side effects and weaken bone. This story is being reported in depth by ABC News, The New York Times, and other major news outlets.  The ABC News coverage, in particular, features stories of real women who have suffered serious consequences — including one who experienced a traumatic leg fracture after simply stepping off a curb.

• I believe the news is going to help women to become more empowered to return to a bone health strategy that makes sense — such as that of the Surgeon General’s “pyramid approach.” This approach says working with nature is the best way to promote bone health, followed by assessing and treating underlying causes affecting bone health. The last option recommended is the use of bone drugs.

I was hoping I would come back from my travels to put up a post that said that the FDA had see the light and was going to recommend limiting the length of time that any individual could take these drugs. But contrary to expectations, they didn’t do so — even though FDA’s own staffers, in a report issued Wednesday, stated that there appeared to be no benefit to continuing the use of bisphosphonates for more than five years.

It’s a shame the FDA finds itself unable to act in the best interests of both doctors and patients alike. What I had hoped was that the FDA would set this limit and help everyone give more serious thought to using bisphosphonates the way they should be used — as a temporary measure in cases of rapid and severe bone loss — and look to natural alternatives for healthy bone as a long-term solution for osteoporosis.

Of course, at the Center for Better Bones, we’ve been talking about the dangers of bone drugs and the better alternatives for years.  You can read more of my thoughts in my article What do I really think of bone drugs, anyway?

 

References:

Sanson, G. 2011. The Myth of Osteoporosis. Santa Barbara, CA: MCD Century Publications, LLC.

Wilson, D. 2011. F.D.A. to review safety of popular bone drugs. The New York Times, September 5, 2011. URL:http://www.nytimes.com/2011/09/06/health/06bone.html. (Accessed 09.09.2011)

Wilson, D. 2011. Stronger cautions backed on bone drugs for women. The New York Times, September 9, 2011. URL: http://www.nytimes.com/2011/09/10/business/fda-panels-back-sterner-language-on-bone-drugs.html. (Accessed 09.09.2011)

CDER. 2011. Background Document for Meeting of Advisory Committee for Reproductive Health Drugs and Drug Safety and Risk Management Advisory Committee. [Downloadable PDF] (Accessed 09.09.2011)


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