Osteoporosis drug guidelines get a makeover from a typically fuzzy FDA report that plays down the dangers
Permanent vacation
Sometimes I think her role as the “Flying Nun” might have prepared Sally Field for life as the Boniva spokesperson. Meaning well, trying to help, and constantly getting it wrong.
Osteoporosis drugs are getting plenty of bad press these days. So Sally might want to see when that contract ends.
Of course, we’ve come to expect this kind of confusion from our FDA officials, but not from beloved icons we thought we could trust.
Weak in the knees
I’ve been telling you this for years. A class of osteoporosis drugs known as bisphosphonates may actually INCREASE risk of bone fracture.
Boniva, Fosamax, and Reclast are three of the popular brands in this class.
Even experts who recommend these drugs say that many women who use them might avoid fracture by taking a “bone holiday.” So let’s review… Take this drug to save your bones. But after awhile, take a “holiday.” Stop taking it to save your bones.
Hmmm… in my book that’s a BIG red flag.
But now the FDA actually suggests that the “holiday” should be a permanent vacation.
A new agency report says this potentially dangerous drug offers little or no benefit after three to five years of use.
That’s devastating news to women who have taken the drug years beyond that cutoff.
In 2008, I told you about two Fosamax studies that came to the same disturbing conclusion. Women who take the drug long-term (about seven years or more) have a higher fracture risk.
And now the FDA tells those women they’ve been putting their bones at risk FOR NOTHING!
Their only consolation is the word “rare.” Experts toss this word around when they talk about fracture risk. Oh, you know, it’s RARE. Like winning the lottery. Very rare. And a New York Times article on the new FDA report joins right in with the “rare” chorus. The article repeatedly stresses the rarity of fracture risk.
Don’t buy it for a second. This risk is not rare like “alien abduction” rare. It’s more like spotting a deer by the highway rare. Infrequent? Yes. Rare? Not so much.
Two years ago, when ABC News reported on Fosamax fracture risk, scores of women went to the ABC website and shared their experiences. Here are just a few of the typical comments from bisphosphonate users…
“…developed aches in my hips, and weakness in the legs…”
“…my femur broke worst pain in the world…”
“…my mother’s femur fractured…”
“…had a slight fall and my left femur shattered…”
“…my right leg just gave out and I fell…”
“…had compression fractures of the spine…”
“…fell and broke my right femur bone…”
“…fell to my knees splitting my femur…”
These painful testimonials go on and on and on. Just try to convince these women that their drug-related fractures are “rare.”
The new FDA report might open a few eyes among doctors. But it’s a typically toothless report. The agency isn’t hinting that these drugs might come off the market. There’s not even talk about a black box warning. In fact, it’s nothing more than talk! Chances are it will never reach the people who need to hear it most. Not unless we do something about it.
Help me sound the alarm. These drugs are ineffective at best and potentially dangerous at worst.
Oh Gidget…
Sources:
“New Cautions About Long-Term Use of Bone Drugs” Tara Parker-Pope, New York Times, 5/9/12, well.blogs.nytimes.com
“Fosamax: Is Long Term Use of Bone Strengthening Drug Linked to Fractures?” Christine Romo, Lara Salahi, ABC News, 3/9/10, abcnews.go.com


