Oops! FDA Admits Huge Osteoporosis Drug Mistake
As you may have probably noticed by now, the FDA tends to backpedal.
They overlook risks and side effects and approve drugs to market. Then, after the drug has done plenty of damage, here comes the FDA again, warning of the drug’s risks.
It’s happened once again with a long-established, rather “fishy” osteoporosis drug.
Thankfully, the Save Our Bones Program is on the cutting edge. From the get-go I’ve been warning about the risks of this “mysterious” drug that even baffles its own maker as to its mechanism of action. When mainstream scientists openly acknowledge that they don’t fully understand how a drug works, you can be pretty sure that it can lead to unpleasant revelations down the road.
And that’s exactly what happened with a well-established osteoporosis drug.
New Announcement: Calcitonin Salmon Doesn’t Work and May Cause Cancer
Calcitonin salmon was approved by the FDA in the mid-1970s because it was thought to increase bone density. But, according to FDA panelist Amy Whitaker “no studies have definitely shown that higher density actually reduces bone fractures,”1 and calcitonin salmon “…has very little evidence of efficacy.”1
The FDA panel has just voted that the risks of calcitonin salmon outweigh any benefits when used to treat osteoporosis. Considering it doesn’t even work, for once, that makes perfect sense!
Now for the really bad news, “…health authorities around the world have been reviewing the drug’s safety after two recent studies showed a slightly higher rate of cancer among patients taking calcitonin pills. 1
Salmon Isn’t the Only Thing That’s Fishy about Calcitonin
If you’ve never heard of calcitonin salmon, it may sound very strange. And frankly, it is! Calcitonin salmon (Miacalcin and Fortical) is inhaled, taken in pill form, or even injected. Miacalcin and Fortical are synthetic versions of calcitonin salmon, a hormone found in the bodies of mammals, birds, and fish. In its natural form, calcitonin works synergistically with parathyroid hormone to help regulate blood calcium levels.
But the mechanism of action of synthetic calcitonin salmon on bone health is not really known. Novartis, the makers of Miacalcin, admit that they do not really know the mechanisms by which this mysterious drug works…and now the not so surprising consensus is that it doesn’t.
My Prediction Comes True
If you’re on the Save Our Bones Program, and if you’re a regular reader of the Save Our Bones blog, you know that hormone therapy is not something I recommend, ever. If you caught my answer posted on Vivian Answers Day #10 from more than 2 years ago, then you are already aware that I was discussing calcitonin salmon and its risks long before the FDA made its recent “discovery.”
When a reader asked about taking calcitonin salmon (Question & Answer #6), I responded with this:
“…my prediction is that one day, the companies that make these kind of drugs might be in troubled waters. I say this because salmon calcitonin’s role is bone metabolism is not well understood, and that can lead to some unwanted surprises as time goes by.”
In addition to the recently-revealed “unwanted surprises,” calcitonin salmon has always carried a risk of unpleasant side effects, such as nosebleeds; sinus pain; joint and back pain; nasal crusts, redness, and swelling; stiffness; and headache. And these are just the common ones. Less-common side effects include bladder infections, hives, swelling of the tongue, breathing difficulty, hair loss, muscle pain, and sweating. And it looks like we can add cancer to that list of side effects as well.
The FDA Can Ignore Its “Experts”, Protecting Big Pharma’s Interests
You aren’t likely to see calcitonin salmon taken off the market any time soon. The FDA is not required to follow the advice of its panels, so the opinions from this recent panel are not automatically going to curtail prescriptions. In other words, calcitonin salmon is likely to continue being prescribed. Time will tell if Big Pharma prevails…
But more importantly, this is yet another reason why the FDA’s drug approval is irrelevant. A drug may be approved, but then “unpleasant surprises” come up down the road, as dangerous side effects are discovered.
Take Fosamax as an example. Approved by the FDA in 1995, the specter of dangerous side effects casts an ever-growing shadow over this drug. The disfiguring side effect known as osteonecrosis of the jaw (ONJ) is particularly associated with Fosamax.
Indeed, the entire class of FDA-approved drugs known as bisphosphonates is burdened by a growing body of evidence against them. Studies have shown that bisphosphonates double the risk of esophageal cancer, and they also increase the risk of atypical femoral fractures.
No Drug is 100% Safe
The bottom line is this: no osteoporosis drug is ever going to be 100% safe. There is always a risk involved with any osteoporosis drug, FDA-approved or not. The drug companies patent synthetic chemicals that more often than not are proven to be dangerous – after they’ve been on the market and caused untold suffering and sometimes irreversible damage.
Leaving your bone health in the hands of Big Pharma and trusting the FDA can leave you with severely damaged health and greatly decreased wellbeing.
This is why taking control of your own bone health is so crucial. The Save Our Bones Program is designed to give you all the information you need to make your own bone health decisions. If you haven’t yet, you can take your bone health into your own hands without ever having to take chances with drugs. Thousands have done it, and so can you!
Till next time,
1 Perrone, Matthew. “FDA panel sees risk in long-used osteoporosis drug.” Associated Press. Google News. March 6, 2013. Web. http://www.google.com/hostednews/ap/article/ALeqM5iLALZYT8s2JFuGRT_URkd_p6OJ0A?docId=9f63b31bdf094dedbf88e7d40593c619