Email a Friend
Print Article
Strong Bones for Life - Naturally (Part 1)
Bisphosphonate Drugs
It's true, as Sally Fields emphasizes in her TV ads for Boniva, that you have only one body; it's not true that Boniva and the other bisphosphonate drugs commonly prescribed to prevent osteoporosis offer the best way to take care of it!
Although prescribed to 30 million Americans each year, the bisphosphonates (e.g., Fosamax, Boniva, Actonel), have now been linked to serious potential complications.
A recent FDA alert warned physicians that all bisphosphonate drugs may cause "severe and sometimes incapacitating bone, joint, and/or muscle (musculoskeletal) pain...[that] may occur within days, months or years" after starting the medication, and in some patients, may not resolve even after discontinuing the drug.
Even more frightening are recent studies conclusively linking bisphosphonate use with jaw osteonecrosis or bone death. Osteonecrosis occurs when bone damaged as a result of poor blood flow or trauma is not removed and replaced with new bone. Initial symptoms include numbness, heaviness, swelling, pain and infection in the jaw, and progress to loosening of the teeth, decay and death of the jaw bone. Bisphosphonates accumulate in bones, particularly in the jawbone, and inhibit the bone's natural ability to repair everyday damage.
A Cochrane Review noted that age = or > 60 years, female sex and previous invasive dental treatment were the most common characteristics of patients taking bisphosphonates who developed osteonocrosis. (Pazianas M, Miller P, Blumentals WA, et al. A review of the literature on osteonecrosis of the jaw in patients with osteoporosis treated with oral bisphosphonates: prevalence, risk factors, and clinical characteristics. Clin Ther. 2007 Aug;29(8):1548-58.) Considering that the target population for bisphosphonate drug use is postmenopausal women, and many women now 60 or older have had some kind of invasive dental procedure in their lifetime, these risk traits for osteonecrosis with bisphosphonate use are far too common for comfort; so common that concerned dentists are highly reluctant to perform any type of dental surgery on women taking these drugs.
In one of the most recent studies, published in the Journal of Oral Maxillofacial Surgery in April 2008, researchers at the University of Southern California's School of Dentistry found a direct correlation between the development of microbial biofilms (bacterial colonies that cause chronic infections) in affected bone and the use of bisphosphonates. (Sedghizadeh PP, Kumar SK, Gorur A, et al. Identification of microbial biofilms in osteonecrosis of the jaws secondary to bisphosphonate therapy. J Oral Maxillofac Surg. 2008 Apr;66(4):767-75.)
Just how many people now have osteonecrosis of the jaw caused by bisphosphonates? Incidence of osteonecrosis among cancer patients, who are given an intravenous and more potent variety of these drugs (e.g., Zometa and Aredia), is estimated at between 1% and 10%. Among those with osteopenia/osteoporosis taking the lower-dose pill forms (Fosamax, Actonel, Boniva), no one knows for sure. Studies to provide firm answers are just beginning, but it has been established that invasive dental procedures, such as tooth extractions or root canals, greatly increase risk of osteonecrosis in women taking bisphosphonates. As for treatments, cutting away the dead bone just worsens the situation, so antibiotic rinses are used, but frequently fail to remedy the condition. And since bisphosphonates remain in bones for years, no one knows how long the risk of osteonecrosis remains, even if the drug is no longer being taken. (Kolata G. Drug for Bones is Newly Linked to Jaw Disease, New York Times, June 2, 2006)
Recent studies have also reported bisphosphonate use as a risk factor for atrial fibrillation (abnormal heart rhythm) in women. One study estimates that 3% of atrial fibrillation cases might have been due to bisphosphonate (specifically, alendronate) use. (Heckbert SR et al.) Physicians are warned that bisphosphonate use needs to be closely monitored in certain populations at high risk of serious adverse effects from atrial fibrillation (such as patients with heart failure, coronary artery disease, or diabetes). In other words, those at risk for serious side effects from bisphosphonates also include anyone with heart disease or diabetes, a significant percentage of the U.S. population. (Heckbert SR, LiG, Cummings SR, et al. Arch Intern Med. 2008 Apr 28;168(8):826-31; Cummings SR, Schwartz AV, Black DM. N Engl J Med. 2007 May 3;356(18):1895-6.)
Not surprisingly, hundreds of lawsuits have now been filed against the manufacturers of biophosphonate drugs, and a class action suit appears likely.
Manufacturers of Bisphosphonates
How Bisphosphonates Work
Even if the bisphosphonates did not put you at risk for severe musculoskeletal pain, the loss of your jaw, or abnormal heart rhythms, these drugs would still not be your best choice for strong healthy bones. Why? Because all they do is suppress bone turnover and remodeling.
Our bones, unless inhibited by bisphosphonates, are constantly rebuilding themselves throughout our lives. Cells called osteoclasts break down old or damaged bone, signaling other cells called osteoblasts to replace it with strong new bone. Bisphosphonates kill osteoclasts. Bone density goes up on these drugs, but the bone they leave in place is worn out tissue your body would normally clear out and replace with strong new bone.
This is why bisphosphonates put people at risk for osteonecrosis (jaw bone death). Because these drugs suppress osteoclastic activity, damaged bone is left in place rather than resorbed, so the amount of damaged old tissue accumulates until it reaches a level when any trauma or insult will result in extremely poor healing, the exposure of necrotic bone to the oral environment, development of pain, and increased risk of microbial infection, which is precisely what is seen in bisphosphonate-associated cases of osteonecrosis of the jaw.
Next: Part 2 - Your Bones, Your Choice
~Joseph Pizzorno, ND and Lara Pizzorno, MDiv, MA, LMT
Related Topics:
It's true, as Sally Fields emphasizes in her TV ads for Boniva, that you have only one body; it's not true that Boniva and the other bisphosphonate drugs commonly prescribed to prevent osteoporosis offer the best way to take care of it!
Although prescribed to 30 million Americans each year, the bisphosphonates (e.g., Fosamax, Boniva, Actonel), have now been linked to serious potential complications.
A recent FDA alert warned physicians that all bisphosphonate drugs may cause "severe and sometimes incapacitating bone, joint, and/or muscle (musculoskeletal) pain...[that] may occur within days, months or years" after starting the medication, and in some patients, may not resolve even after discontinuing the drug.
Even more frightening are recent studies conclusively linking bisphosphonate use with jaw osteonecrosis or bone death. Osteonecrosis occurs when bone damaged as a result of poor blood flow or trauma is not removed and replaced with new bone. Initial symptoms include numbness, heaviness, swelling, pain and infection in the jaw, and progress to loosening of the teeth, decay and death of the jaw bone. Bisphosphonates accumulate in bones, particularly in the jawbone, and inhibit the bone's natural ability to repair everyday damage.
A Cochrane Review noted that age = or > 60 years, female sex and previous invasive dental treatment were the most common characteristics of patients taking bisphosphonates who developed osteonocrosis. (Pazianas M, Miller P, Blumentals WA, et al. A review of the literature on osteonecrosis of the jaw in patients with osteoporosis treated with oral bisphosphonates: prevalence, risk factors, and clinical characteristics. Clin Ther. 2007 Aug;29(8):1548-58.) Considering that the target population for bisphosphonate drug use is postmenopausal women, and many women now 60 or older have had some kind of invasive dental procedure in their lifetime, these risk traits for osteonecrosis with bisphosphonate use are far too common for comfort; so common that concerned dentists are highly reluctant to perform any type of dental surgery on women taking these drugs.
In one of the most recent studies, published in the Journal of Oral Maxillofacial Surgery in April 2008, researchers at the University of Southern California's School of Dentistry found a direct correlation between the development of microbial biofilms (bacterial colonies that cause chronic infections) in affected bone and the use of bisphosphonates. (Sedghizadeh PP, Kumar SK, Gorur A, et al. Identification of microbial biofilms in osteonecrosis of the jaws secondary to bisphosphonate therapy. J Oral Maxillofac Surg. 2008 Apr;66(4):767-75.)
Just how many people now have osteonecrosis of the jaw caused by bisphosphonates? Incidence of osteonecrosis among cancer patients, who are given an intravenous and more potent variety of these drugs (e.g., Zometa and Aredia), is estimated at between 1% and 10%. Among those with osteopenia/osteoporosis taking the lower-dose pill forms (Fosamax, Actonel, Boniva), no one knows for sure. Studies to provide firm answers are just beginning, but it has been established that invasive dental procedures, such as tooth extractions or root canals, greatly increase risk of osteonecrosis in women taking bisphosphonates. As for treatments, cutting away the dead bone just worsens the situation, so antibiotic rinses are used, but frequently fail to remedy the condition. And since bisphosphonates remain in bones for years, no one knows how long the risk of osteonecrosis remains, even if the drug is no longer being taken. (Kolata G. Drug for Bones is Newly Linked to Jaw Disease, New York Times, June 2, 2006)
Recent studies have also reported bisphosphonate use as a risk factor for atrial fibrillation (abnormal heart rhythm) in women. One study estimates that 3% of atrial fibrillation cases might have been due to bisphosphonate (specifically, alendronate) use. (Heckbert SR et al.) Physicians are warned that bisphosphonate use needs to be closely monitored in certain populations at high risk of serious adverse effects from atrial fibrillation (such as patients with heart failure, coronary artery disease, or diabetes). In other words, those at risk for serious side effects from bisphosphonates also include anyone with heart disease or diabetes, a significant percentage of the U.S. population. (Heckbert SR, LiG, Cummings SR, et al. Arch Intern Med. 2008 Apr 28;168(8):826-31; Cummings SR, Schwartz AV, Black DM. N Engl J Med. 2007 May 3;356(18):1895-6.)
Not surprisingly, hundreds of lawsuits have now been filed against the manufacturers of biophosphonate drugs, and a class action suit appears likely.
Manufacturers of Bisphosphonates
- Fosamax - Merck & Company
- Boniva - Roche and GlaxoSmithKline, popularized by Sally Field commercials
- Actonel - Proctor & Gamble Pharmaceuticals, Sanofi Pharmaceuticals
- Skelid - Sanofi Pharmaceuticals
- Didronel - Proctor & Gamble Pharmaceuticals
- Reclast and Zometa - Novartis Pharmaceuticals
How Bisphosphonates Work
Even if the bisphosphonates did not put you at risk for severe musculoskeletal pain, the loss of your jaw, or abnormal heart rhythms, these drugs would still not be your best choice for strong healthy bones. Why? Because all they do is suppress bone turnover and remodeling.
Our bones, unless inhibited by bisphosphonates, are constantly rebuilding themselves throughout our lives. Cells called osteoclasts break down old or damaged bone, signaling other cells called osteoblasts to replace it with strong new bone. Bisphosphonates kill osteoclasts. Bone density goes up on these drugs, but the bone they leave in place is worn out tissue your body would normally clear out and replace with strong new bone.
This is why bisphosphonates put people at risk for osteonecrosis (jaw bone death). Because these drugs suppress osteoclastic activity, damaged bone is left in place rather than resorbed, so the amount of damaged old tissue accumulates until it reaches a level when any trauma or insult will result in extremely poor healing, the exposure of necrotic bone to the oral environment, development of pain, and increased risk of microbial infection, which is precisely what is seen in bisphosphonate-associated cases of osteonecrosis of the jaw.
Next: Part 2 - Your Bones, Your Choice
~Joseph Pizzorno, ND and Lara Pizzorno, MDiv, MA, LMT
Related Topics:
Labels: bones, integrative medicine, osteoporosis
10 Comments:
I have used Boniva for about 5 years and now have excruciating bone pain. It started with rt. shoulder blade pain, then right humerus, then left shoulder blade, now entire rib cage. the only way to get relief is to lie flat on my back and take Vicodin 50/500x2 4xday. I have concerns about dependence and would love to know of another way to relieve pain. X-ray, MRI,EMG show nothing out of the ordinary so problem has to be the Boniva. Obviously I have stopped taking it. Is there any hope that this pain will ever stop????
Obviously, I can't diagnose or treat you over the internet. As you have probably now discovered pain appears to be a common side effect. The good news is that stopping the drug eventually results in pain relief for most users. Dr. Pizzorno
I took my first Boniva pill at the urging of my Dr. because my bone density was almost at the osteoporsis level. I was very achy that night but felt fine ever since. Now that I read this article I will stop taking the medication for fear of complication. Is there anything I can do to stop it's action like an antidote or at least neutalize it?
The first patient I saw with bone pain on a bisphosphonate had undetectable Vitamin D levels. Her bone pain went away with replacement of Vitamin D. MD, Idaho.
I am so confused by all the information I have been reading about Boniva and all the other Osteoperosis medications? I found out a month or so ago that i have Osteoperosis in the hip and Osteopenia in the spine. I was give Boniva to take. After reading the material that came with the samples I was not comfortable about taking it. Last week I found out that i shouldn't take the pill because I had a fundilplication. The doctor suggested i ask my family physician about taking IV Boniva and she came back with Reclast. Nothing I seem to read is positive about the affects of the drugs. What happens if I don't take any medicine? What do I gain taking the medicine? Which medicine should I take if I need to take a medicine to prevent bone loss?
I am a 55 y/o man and I've had flat feet all my life, can the arch in the foot be rebuilt?
I am a writer of healthcare materials for patients. One product I work on is for bone metastates in cancer patients. The product they are given, an IV bisphosphonate, comes with STRONG recommendations that patients take daily calcium and vitamin D supplements, and that they have a complete dental exam and any needed dental procedures before starting the medication. Perhaps there are similar recommendations for osteoporosis patients taking Boniva? There are ways to reduce the risk of osteonecrosis, or to catch it as soon as it starts. As with everything, you have to gather good quality information (start with having a long talk with your doctor or his nurse/NP/PA), then weigh the benefits versus the risks. You have to be your own best advocate when it comes to your health.
Mary said...
I am a 58 year old generally healthy woman. I have just been diagnosed with avascular necrosis of the shoulder. After 3 years of frozen shoulder issues, shoulder manipulation, PT, and repeated attempts to reduce the pain. The most recent visit to an orthopedic doctor presents with a possible
should replacement. We will know more when he reads the results of MRI and bloodwork.
I took Fosamax or actonel for about 2 years then took myself off because of what i had read. But 3 doctors kept recommending that I take it because of dexascan scores. I went back on it for about a year. I am so angry about this drug and how many women are being "forced" in to taking something that doesn't work and may cause them harm.
I have had health problems since i was 17, it started with ulcerative cholitis and at age 20 they had to remove my large intestens and my bowls i wore an illeostomy for 5 months then they reversed it. I was on a lot of steriods when i was diagnosed and thru the years have been diagnosed with sinusitis,psoriasis,irritis,i get pouchitis when i get to much bad bacteria on the pouch inside me. than at age 39 i was diagnosed with avascular necrosis of both shoulders. i had my left one replaced and the pain is a little better but my muscles and my back are still very painful. im hoping to have my rt one done soon. im to take boniva but have been to scared to take it. not to mention all the other meds im on. Pain meds muscle relaxers, anxiety meds. i just hope when i get my rt shoulder done the pain and muscle spasms stop, the drs dont think that will happen. is there anyone else out there like me? i would love to hear from you. Sorry for the long comment but i have a lot going on. thank you
I just got my first boniva iv 3 weeks ago. They put it in my wrist, and my wrist is still swollen and red and part of my hand and wrist feels partially numb and tingly when touched. Its also sore when I bend my wrist and I can only bend it a certain degree.
Post a Comment