The Food and Drug Administration (FDA) has added its strictest warning to Amgen's osteoporosis drug Prolia (denosumab). The move comes after years of additional monitoring and testing of a known problem with the drug. The FDA has reported outcomes for Prolia users that include hospitalization and death.
We will explain the risk associated with this osteoporosis drug and what this means to Prolia users.
Black Box Warning Added To Prolia
The FDA has added a black box warning — the agency’s most severe health warning — to the prescription osteoporosis drug Prolia (denosumab). The new label warns that the drug can lead to dangerously low levels of calcium in the blood.
This condition, called hypocalcemia, is especially dangerous for people with kidney disease, which also reduces calcium levels. In people with kidney disease, the FDA found that this side effect resulted in hospitalization, life-threatening events, and in some cases death.
The FDA has warned that hypocalcemia symptoms include confusion, irregular heart rhythm, fainting, muscle spasms, and weakness advising Prolia users to watch for these dangerous side effects.
Synopsis
The FDA has added a black box warning to the label of Prolia (denosumab) warning that it can dangerously increase the risk of hypocalcemia (low blood-levels of calcium). The condition has resulted in hospitalization, life-threatening events, and in some cases death.
All About Prolia
Prolia is a monoclonal antibody administered every six months as a subcutaneous injection. It suppresses osteoclasts, the cells responsible for breaking down old and damaged bone as part of the bone remodeling process.
To do this, Prolia mimics a tumor necrosis factor (TNF) cytokine named osteoprotegerin. Osteoprotegerin blocks the function of RANK Ligands (RANKL). RANKL is a protein that activates osteoclasts and converts osteomorphs (retired osteoclasts) back into active osteoclasts. By blocking the effects of RANKL Prolia inhibits osteoclast function and formation.
The resulting accumulation of old, damaged bone leads to an increase in bone density. However, as Savers are aware, our bones are much healthier when they can complete their bone remodeling process supported by a drug-free, bone-healthy lifestyle.
When Prolia was first approved by the FDA 14 years ago, it already carried a warning for hypocalcemia, but the FDA required Amgen to conduct additional clinical testing to further assess safety.
The agency delayed issuing a stricter warning until it reviewed studies conducted by the Centers for Medicare & Medicaid Services. Evidently, a number of people died during this process as a result of hypocalcemia linked to Prolia and kidney disease.
In a decision characteristic of the FDA, rather than removing this hazardous drug from the market, it issued an advisory that patients taking Prolia should maintain adequate calcium and vitamin D intake. For patients with advanced kidney disease, the FDA advised frequent monitoring of calcium levels in the blood.
Amgen, the Big Pharma company responsible for Prolia, earned $2.9 billion in revenue selling the drug in the nine months ending Sept. 30 of this year. As usual, the FDA and Big Pharma seem to put profits over the safety of consumers.
Synopsis
Prolia is an injectable drug made by Amgen, approved by the FDA 14 years ago. It blocks RANKL proteins by imitating a RANKL inhibitor called osteoprotegerin. RANKL inhibition results in suppression of osteoclast function and formation, leading to an increase in bone density.
How To Avoid Hypocalcemia And Other Drug Side Effects
Hypocalcemia is not unique to Prolia, although Prolia was found more likely to cause the condition than older oral bisphosphonates. Many osteoporosis drugs carry black box warnings, and all of them have a list of severe negative side effects.
- Evenity (romosozumab), another injectable monoclonal antibody, can also cause hypocalcemia in people with advanced kidney disease. Evenity was given a black box warning for increasing the risk of heart attack, stroke, and related death. Other severe potential side effects include osteonecrosis of the jaw and atypical femur fracture.
- Forteo (teriparatide), an injectable drug that works by imitating parathyroid hormone, can also cause hypocalcemia. It was given a black box warning for increasing the risk of osteosarcoma (bone cancer).
- Protos, now called Aristo, (strontium ranelate), is an oral drug used in other countries, but not approved by the FDA, that has a black box warning due to increased risk of heart attack.
- Tymlos (abaloparatide), another injectable drug, has a black box warning for increasing the risk of bone cancer. It may also cause orthostatic hypotension, hypercalcemia (too much calcium in the blood), and hypercalciuria (excess calcium in the urine).
- Fosamax (Alendronic acid) is an oral drug that carries a black box warning for increasing the risk of atypical femur fractures. Other severe side effects include hypocalcemia, osteonecrosis of the jaw, severe pain, and stomach bleeding.
The best and safest way to build your bones and improve your health without the risk of potentially devastating side effects is to pursue a drug-free, all-natural approach to prevent and reverse Osteoporosis.
That's what the Osteoporosis Reversal Program is all about. It tackles bone health on multiple fronts in multiple ways.
Through simple, gradual shifts to diet, exercise, and lifestyle choices, you can build stronger bones and a more active and healthy life. And the Saver community is made up of of people who are choosing to prevent falls and fractures without drugs, and they're using scientifically proven methods to do it. You can too.
Synopsis
Many osteoporosis drugs bear black-label warnings about their severe potential side effects, including Evenity for heart attack, Forteo for bone cancer, Protos (or Aristo) for heart attack, Tymlos for bone cancer, and Fosamax for atypical femur fracture. The only way to rule out potentially devastating drug side effects is to pursue a drug-free path to preventing and reversing osteoporosis.
What This Means To You
It took the FDA 14 years to put an appropriately forceful warning on Prolia's label. Every single person who took the drug over those years did so without knowledge of the drug's true risk level. As a result, people needlessly died.
If you're taking Prolia, talk with your doctor about this new black box warning. Ironically, stopping Prolia carries its own set of risks. This is what happens: when the drug stops preventing osteomorphs from becoming osteoclasts, a flood of new osteoclasts get formed. The result is sudden bone loss and an increased risk of fracture. If you wish to stop taking medication, consult with a medical professional.
Whether you have taken osteoporosis drugs in the past, are currently using them, or are considering the best way to improve your bone health– the Osteoporosis Reversal Program can help you improve the quality and health of your bones naturally. Best of all, the only side effect is a longer, fuller, more independent life.
References
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At the Save Institute, we don’t recommend taking strontium. Here’s an article about it that explains why:
https://saveourbones.com/strontium-science-based-facts-vs-fiction/
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Thank You for the good information
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You’re welcome, Maria!
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Please comment on taking Algaecal supplement daily versus risidronate
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There’s no comparison between the two, Maureen! Here’s information on the bisphosphonate risedronate:
https://saveourbones.com/actonel-benefits-really/
And remember that you can always search our blog by clicking on the “Search” icon at the top right of your screen 🙂
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I have been on Prolia injection for 8 years now and have never had any of the issues people are mentioning here with it. I also take Fosteum Plus which is a medical grade food calcium along with vitamin D&K.
I do a lot of weight bearing exercises along with riding my bike 20-25 miles about 5 times a week. and Densercise. I am 66 this year. My last dexa scan showed I was back to normal in 2 areas and moved from Osteoporosis to Osteopenia in 2 areas. I recently had labs done and my calcium levels was 9.2mg/dl range 8.3-10.8mg/dl. my vitamin D was 73.7ng/mL which is on the higher end. I get my next dexa April and my next injection in April. I will be discussing with my doctor whether I should continue or not. -
Wonderful information about all the drugs for osteoporosis. I would like to know if one of the drugs listed is also called Reclast. I took that for 4 years. Now my doctor wants to take Prolia. I don’t think so.
Thank you-
Antoinette, you’re on the right track 🙂
We have many articles on Reclast (zometa), and you can find them here:
https://saveourbones.com/?s=reclast-
Hi Vivian,
My Endocrinologist wants me to go on
Either Forteo or Romososumab.
I have bargained for more time, to not go on it .
However my Dr says that gym, yoga and diet is not going to help me . I am so confused and anxious about this . 75 years old in good health apart from this . No fractures , no falls and very active .Gluten free and dairy free . Doing weights twice / week and yoga twice / week . Swimming every morning
No medication except supplements (d3 and (k2 and Natto ..
I feel so overwhelmed and lonely in my trying not to go on drugs how can I go against my Dr ( who supposedly in looking after my best options )
No medication only d3 and
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Hello, Vivian
I know you have recommended TruOsteo in the past and I take that and I think it cured my leg cramps at night. But there is also AlgeCal and it looks good too.
What are the pros and cons? or are they both about the same. Thank you –I am sue other Savers would like to know too. I have asked you before but I am not sure where that response might have been. You might not want to recommend a specific product but I would just like to know the differences. You could email me rather than make it public if you want. Thank you for the work that you do. Gwin
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Dear Gwin,
We’re happy to provide you with Vivian’s answers to your questions. Please check your email inbox within the next 24-72 hours.
In excellent health,Customer Support
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Hi Gwin,
I take Bone Builder support from MetaGenics which I purchased from a registered dietician for several years, worked really hard at eating clean and alkalizing diet, saw no change in my bone density, in fact, it got worse.
So I would be interested in knowing what Vivian’s answer was.
Doctor has put me on Fosamax which I resisted for 2 years. I go to the gym and walk outside from spring to fall, treadmill in the winter. If you get a chance, it would be great to hear from you regarding the above.Thank you,
Debby
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Thank you , Ita.
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You’re welcome, Ita!
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How can I stop taking Prolia? I have had only two doses —one year — if my Doctor doesn’t want me to stop?
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You’re the decision-maker, Judith… not your doctor. We discuss this topic in detail in the Doctor Communication Tutorials that’s included with the Osteoporosis Reversal Program.
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As a breast cancer survivor, I take a medication, Anastrazole, which keeps estrogen related breast cancer from returning by lowering estrogen. One side effect is that osteoporosis is made worse because of decreased estrogen. My osteoporosis was severe to begin with. So, I was encouraged to take Prolia, which I did. I immediately got a UTI which I never get. Now I am faced with getting a second injection of Prolia. Distressed about the black box warning.
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Angela, there are natural ways to improve bone health and prevent fractures, as explained in the Osteoporosis Reversal Program. Of course, the decision is in your hands. Wishing you good health!
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I tried Prolia several times. I spread out the injection longer than normal. I believe I did it 3 times. I started having problems with my legs: It actually started out with burning in the back of my ankles, my legs would get tired for no reason, cramps, my bone, in front of leg, from ankle on up would burn, my calves sometimes felt like they were made of stone. I had problems with my knees. I had a hard time walking, and walking up the stairs was very painful. I feel every problem you could have with your legs, I had. Shortly after, it turned out I also had an insufficiency fracture in my knee (caused by going off the Prolia. Doctors don’t tell you if you go off you should go on another medication) Luckily, these symptoms, did not happen all at once. My doctor sent me to a specialist who did some tests. Everything came back negative. I told her and my doctor I KNOW this was caused by the Prolia. Both wouldn’t say yes, but maybe, because none of the doctors will say yes it is the Prolia. I got lucky because after about 6-8 months it started getting better. (I have read someone was permanently in a wheelchair from it). I also chose no drugs and will take my chances.
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Thanks for sharing your experience with Prolia, Sandra. Keep up with natural protocols to improve your bone health 🙂
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I recently saw my doctor about pain management (pain killer or anti-inflammatory) in case I need it. I’ve had a crush fracture in T8 and I’ve been learning to deal with it. Pain can be anywhere between none and servere depending if I’ve aggravated it somehow.
My doctor has been wanting me to use drugs (Prolia) and uses the fear factor saying that my dexa scans are bad and I’ll probably end up with more spontaneous fractures. I don’t think it was spontaneous. He means well but my choice is still no drugs, especially after reading this.-
Good choice, Nicola!
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Is Algae Cal with strontium recommended… I read strontium was a no no, but algae cal itself is good overall ? Any benefit to taking the one with strontium ?
Thanks
Alla