Are Osteoporosis Prescriptions Safe? | FDA Warnings
Updated: Jan 22
To answer the question, are osteoporosis prescriptions safe, we will list well-documented facts within a timeline form and give you a high-level overview of some of the issues.
You can make your own decision if osteoporosis prescriptions are for you.
Just a few things before we get started. You will see the word Fosamax a lot. Fosamax was the first of a growing list of prescriptions using bisphosphonates. Within the FDA warning is this statement,
FDA Warning #1 - Bisphosphonates Not the Brand, The Ingredient
” … U.S. Food and Drug Administration (FDA) to release a series of Fosamax FDA warnings regarding the safety of the drug and other bisphosphonates.” FDA Drug Safety Communicaton
That statement means that regardless of brand name, the warnings are aimed at all bisphosphonate brands.
Not enough time to go through this whole article?
Go to The Real Issues Here at the bottom of this article for the summation.
Popular Current Bisphosphonate Products
The more popular current products which are bisphosphonate based are:
Actonel with Calcium
Are Osteoporosis Prescriptions Safe – The FDA Time Line
1995 – Fosamax Approved
Fosamax was approved based on a study called The Fraction Intervention Trial. We do not know who funded the study.
There were two groups of subjects: the placebo group and the Fosamax group. Each group was 100 in size and followed for 4 years.
The placebo group had 2 fractures in the 4 years.
The Fosamax group had 1 fracture in the 4 years.
That data can be interpreted in two ways: The Merck company [ maker of Fosamax ] saw a 50% reduction if fractures. Those not tied to a positive financial outcome saw a lot of Fosamax consumption and potential cost for minimal gain.
FDA Warning 2
2004 – FDA Finds Long-Term Use of Fosamax Linked to Osteonecrosis
Osteonecrosis is a condition where your jawbone deteriorates.
FDA Warning 3
2007 – FDA Issues an Atrial Fibrillation Warning
A 2007 Fosamax FDA warning discussed concerns regarding a potential risk for atrial fibrillation in patients taking Fosamax and other bisphosphonates” source
The warning was prompted after The New England Journal of Medicine showing increased atrial fibrillation rates were increasing among patients taking the drug for osteoporosis treatment.
FDA Warning 4
2008 – FDA Warning Fosamax Severe Pain Alert
In 2008, the FDA released an alert regarding bisphosphonates such as Fosamax, Actonel, Reclast, and Boniva. The warning noted to consumers that many bisphosphonate users suffered severe bone, muscle, or joint pain during treatment with the drugs. In many cases, patients reported pain that was so debilitating that it interfered with their normal, daily activities.” drugdangers
The pain started for some users within days. Others reported it after months and in some cases, years after taking bisphosphonate treatment. Some users reported pain relief after the treatment started. The medical community dismissed the report as a symptom of osteoporosis. Despite the differences, the announcement urged doctors to temporarily or permanently discontinuing the therapy for patients reporting pain. Are osteoporosis prescriptions safe? Not to this group of people.
FDA Warning 5
2009 – Swedish Study – Femur Stress Fracture 50 time higher with Bisphosphonates
Let’s make sure we get this right, Bisphosphonate prescriptions increase the of Femur Stress Fracture of over 50 compared to those NOT taking the prescription.
FDA Warning 6
2009 – FDA Issued a Communication about the Risks of Esophageal Cancer
“In 2011, the FDA issued a Drug Safety Communication discussing the potential risks of bisphosphonates and esophageal cancer.” New England Journal of Medicine
There were two conflicting reports. One report stated there was no bisphosphonates cased increase. However, another major study which examined bisphosphonates patients for over 4 years, had double the risk of developing esophageal cancer.
2009 – Fake Medical Journal to Sell Fosamax
In 2009, The Scientist magazine reported that Merck paid publisher Elsevier to produce the Australasian Journal of Bone and Joint Medicine, which looked like a peer-reviewed medical journal. In reality, it was a marketing tool for Fosamax and other Merck products, including its then blockbuster pain reliever, Vioxx. The journals were published from 2003 to 2004.
Samples of the journal surfaced in a civil suit against Merck for Vioxx. It included only positive conclusions about the drugs. There were 12 articles dedicated to Fosamax. Many of the supposed articles had no authors and few references. Elsevier admitted Merck had sponsored the publication and there were no disclosures to indicate it was sponsored by Merck. Critics said it was a ploy to trick doctors who might be influenced by the publication. source
FDA Warning 7
2010 – FDA Warning Increased Risk of Hypocalcemia
“The Fosamax warning also indicates a potential increased risk of hypocalcemia or low blood calcium levels.” source
FDA warned about the potential increased risk of hypocalcemia, known as low blood calcium levels. Symptoms include:
Spasms or cramps in muscles
Tingling or numbness in Toes, Fingers or around the mouth
FDA Warning 8
2010 – FDA Warns of Potential Increased Risk of Femur Fracture
“In 2010, the FDA released a Drug Safety Communication warning the public of the potential increased risk of sustaining fractures in the femur, or thigh bone, in bisphosphonate patients. These atypical fractures include diaphyseal and subtrochanteric fractures. Diaphyseal fractures occur along the long shaft of the bone. Subtrochanteric fractures occur immediately below the femur’s lesser trochanter, or just below the hip joint.” FDA Drug Safety Communication
After the FDA warning, manufacturing companies were required to add information about fractures to bisphosphonate safety labels. The warning was not issued for treatments exclusively for Paget’s disease or cancer high blood calcium.
FDA Warning 9
2011 – FDA Adds New Warning Lable to Limit the Time of Patient Usage
No agreement as to that time limit, but now seems to be 5 years by consensus.
FDA Warning 10
2015 – FDA Osteonecrosis Warning
“The FDA has required the Fosamax label to include warnings of a condition called osteonecrosis of the jaw.” source
Osteonecrosis is also known as Dead Jaw Syndrome. Osteonecrosis can lead to the complete collapse of the jaw bone. Many times Osteonecrosis starts with routine dental work. FDA required label warnings for the osteonecrosis condition.
To help you answer the question, are osteoporosis prescriptions safe, click to see images of Osteonecrosis. Warning, the images are not for the faint of heart. They are quite gross, shocking and unpleasant to look at. But this does show this one side effect of osteoporosis prescriptions for some people.
Are Osteoporosis Prescriptions Safe?
This article is not the full story to answer to the question, are Osteoporosis Prescriptions safe, but an overview looks at FDA warnings well help you make up your mind. There are many more warnings and a much longer list of bisphosphonates side effects which were not within the scope of this post.
There are many natural ways of dealing with Osteoporosis. We will be writing about those options very soon.
The Two Sides of the Issue
Are bisphosphonates really that useful, especially when you count all the side effect issues? Some say yes, and some say no.
One thing to keep in mind is the value of the Osteoporosis Drug industry. That amount is $3.7 Billion [$3,700,000,000] for 2014 – 2015. source
We suggest and advise you to be aware of and understand they are two opposing views of Bisphosphonate Osteoporosis Drugs.
One view has $3.7 Billion to $4 Billion financial interest. One would expect the language contained in the “How Effective Are They?” paragraph above.
The other view is not financially connected to the $4 Billion industry, and are more interested in the health of the patients who have Osteoporosis.
To be fair, this site does offer natural alternative options for the Osteoporosis prescriptions, so we do have a financial interest in the debate. Our economic benefits are entirely and wholly insignificant to the $4 Billion drug industry. We do not even show up on the graph. Our motivations are pushed by first-hand knowledge of the effects of the prescriptions.
We remind you to read the FDA warnings again.
Are osteoporosis prescriptions safe? Well we know one thing, they are profitable to big pharma.
How do Bisphosphonates Work?
“Bisphosphonates bind to the surfaces of the bones and slow down the bone resorption action of the osteoclasts (bone-eroding cells). This allows the osteoblasts (bone-building cells) to work more effectively. source
Here in lies a basic inherent paradox with Osteoporosis Drugs.
If Bisphosphonates bind to the bones to decrease the release of bone minerals and thereby increase bone density, then how does that affect the body’s effort to add minerals to the bone?
There is a good reason why your body takes minerals from the bone and put them in the bloodstream. Those minerals are needed by the organ of the body to function properly. Bisphosphonates seem to forget that basic body function. Therefore by its very design, Bisphosphonates cause other health problems that no one is discussing. So what do you think? Are osteoporosis prescriptions safe?
The Real Issues Here
Remember the FDA Warning Increased Risk of Hypocalcemia? Hypocalcemia is a condition of low calcium in the blood. It creates the problem is intended to solve!
If bisphosphonates are designed to slow down or stop the bone from releasing minerals into the bloodstream, causing Hypocalcemia, then it would seem to make matters worse not better.
Important Concepts Not in the National Discussion About Bone Health
Are osteoporosis prescriptions safe? Consider this:
All vital organs and tissues require minerals to be released from your bones on a daily basis. Joints, Heart, Brain, Intestines, Muscles, Kidneys, and Ears all need the minerals that the bisphosphonates have reduced or stopped. Their function declines as you exhibit a whole new set of symptoms which you take to your doctor who may pull out his prescription chart to recommend more drug treatment. The basic concept of bisphosphonates treatments seems to lead to more prescriptions automatically.
But the real solution to bone health is not even being discussed. That question is this, “How to get more minerals to the bone?” That would be the solution! Actually, solve the problem! Would be of interest to bone health suffers to have a naturally safe and inexpensive way to solve Osteo issue?
So in our opinion the answer to the question, are osteoporosis prescriptions safe, the answer is No, they are not. However,that is a decision for you and your doctor.