In a jaw-dropping and perhaps literally jaw-killing decision, the FDA recently approved a new bone drug for women that may lead to worse bones and even cause bone death. Yes, you read that right – Amgen’s newly approved bone drug Prolia, which is designed to lower the risk of fractures in post-menopausal women, may also carry a significant risk of actually causing bone death of the jaw as well as weaker, more brittle bones. Of course, this is what the drug was designed to prevent. And that isn’t all of the bad news.
The new drug is designed to address bone resorption and bone formation, which is a natural and essential process that rebuilds bone structure by removing old bone components (resorption) and replacing them with new ones via bone formation. Low estrogen and progesterone levels in post-menopausal women cause bone to be broken down more quickly than it can be replaced. As a result, such women often have weak, brittle bones and higher susceptibility to breaks and fractures.
Prolia is a so-called monoclonal antibody – a lab-produced antibody that inactivates the body’s bone-breakdown mechanism. Like biophosphate bone drugs, Prolia targets the body’s ability to break down bone components. Prolia does this by targeting a chemical signal in the body called RANK ligand, which is an essential part of the body’s natural process for breaking down bones. The idea is that by slowing the process down, bones will lose less bone mass and be less brittle. While the idea looks good on paper, it can be fraught with danger in actual practice.
A WebMD article described the way Prolia works: “The drug slows the bone-breakdown process — but also slows the entire bone-remodeling process. Over the long term, it’s not yet clear what this will mean.”
The problem is that suppression of bone breakdown may lead to bone formation outstripping bone breakdown, and this has happened with Fosamax and other biophosphate bone drugs. With the other bone drugs, new bone formation often produces unnatural bone growth and results in bones that are actually more susceptible to fractures and abnormalities. Even worse, the bone drugs have caused even more dangerous conditions, including bone death of the jaw and spinal paralysis.
There appear to be no assurances that Prolia will not lead to the same kind of problems. As the FDA’s own press release warns, “”Prolia causes significant suppression of bone turnover and this suppression may contribute to the occurrence of osteonecrosis of the jaw, a severe bone disease that affects the jaw, atypical fractures, and delayed fracture healing.”
Osteochronosis, which literally means “bone death”, is one of the more severe side effects that have been reported for other bone drugs. And, as if bone death of the jaw were not enough of a concern, several disconcerting side effects were observed in Prolia’s clinical trials.
As WebMD reported, “In clinical trials, women taking Prolia had a higher risk of serious infections leading to hospitalization, including heart infections. Skin reactions such as dermatitis, rashes, and eczema also were reported.”
Some of the other side effects included:
Pain in the extremities
High cholesterol levels
Urinary bladder infections
Lowered levels of calcium, an essential mineral for healthy bones.
So there you have it, the FDA has approved and trumpeted yet another unnatural Big Pharma drug whose side effects may far outweigh the benefits. What the FDA won’t likely approve or trumpet are the many safer and less expensive natural ways that women can beat and avoid osteoporosis.
See for example: