Xgeva, Prolia Bone Drugs Linked to Deadly Low Calcium Levels

  • Written by: Irvin Jackson

Individuals in multiple countries are being warning about potentially life-threatening health risks associated with low calcium levels that may be caused by side effects of the bone drugs Xgeva and Prolia. However, it does not appear that similar information is being provided to physicians or patients in the United States. 

Amgen, the makers of Xgeva and Prolia, recently warned drug regulators in the U.K. about cases of severe hypocalcemia that have occurred among some patients, causing severe injuries and death.

In a statement released last month by the U.K.’s Medicines and Healthcare products Regulatory Agency (MHRA), the British equivalent of the FDA warned doctors that they should carefully monitor calcium levels in patients taking the drugs.

A similar warning was sent to Canadian health officials in a “public communication” letter (PDF) sent by Amgen on May 31, 2012.

According to the consumer advocacy group Public Citizen, no such warnings have been made public in the United States and the FDA has not warned U.S. physicians about the importance of monitoring calcium levels for users of Xgeva and Prolia.

Xgeva (denosumab) is approved in the U.S. to treat loss of bone density in patients suffering from cancer that has spread to the bones. A lower dose version, Prolia, is used as a treatment for osteoporosis in patients who do not have cancer.

In the latest issue of Public Citizen’s Worst Pills, Best Pills newsletter (subscription), the group is urging individuals using the medications for either cancer or osteoporosis to contact their health care providers immediately if they experience any symptoms of hypocalcemia, or low blood calcium, which could include confusion, muscle spasms, twitching or cramping, or irregularity of the heart rhythm.

Amgen’s warnings provided outside the U.S. indicate that the drugs may lower calcium levels in the blood to dangerous levels, especially in patients with kidney problems. Deaths have occurred among patients being given Xgeva, which has 120 mg of the active ingredient, but not among users of Prolia, which has only 60 mg of the active ingredient.

While most incidents appear to occur within the first six months of treatment, Amgen and foreign drug regulators have indicated that side effects of Xgeva and Prolia may strike at any time during treatment.

In April, the FDA rejected a request by Amgen to approve Xgeva for the treatment of men with prostate cancer that had not spread to their bones. The FDA’s advisory committee said clinical evidence did not show a significant enough benefit for patients to take on the risks of the drug’s side effects. The FDA’s drug reviewers agreed.

Tags: , , ,


  1. colleen Reply

    I took the drug xgeva from 12/08/2010 to 7/18/2012. First my tooth broke off. The root is still in the jaw. This is because of the fear of ONJ spreading. Then my left hip was hurting so bad, I was unable to walk. an ER visit showed my femur head was nearly destroyed. A visit to a hip surgeon told me there was nothing he could do to help me. I am able to walk with a walker now. As I do I can hear the bone grinding and bumping on the other bones. The distortion caused by Xgeva to this beautiful structure is sickening to see.

  2. pam Reply

    I started taking the prolia shot last year because of fractures in my feet. I started experiencing multiple symtoms after the 2nd shot 6 months later. Still not thinking that the shot was the problem, I called my Dr and told him about the unending itching and red splotching all over my bady. He told me to see a derm, first one told me I had age spots and that was it ! take a anti itch cream or benadryl….Ha Ha!! that was a great help! I was getting my blood work done one day and was reading a magazine that had a prolia advertisement. I was stunned to read about the side effects. I had read them 8 months earlier and as most people do didn’t pay that much attention. Well after I started to experience a decline in the way I was feeling I was amazed to see the things I was experiencing was on the list of adverse reactions of the shot. broken tooth, jaw pain ,neck pain ,non stop itcing, red spots, kidney stones, back pain and the list goes on! This drug need to be taken off the market. I want to be notified if there are any lawsuits pending…

  3. Sharon Reply

    It has been about 4 months ago when I had my first shot of Prolia. I will never have another one. I have RA, Osteoarthritis and two small fractures from Osteoporosis, My RA doctor thought Prolia would be a good thing for me. Within just days after the shot my back (which all ready had chronic pain) started hurting even more and my two knees with knee replacements began to be extremely painful and that hasn’t let up. I had a orpthopedic surgeon check the knees and the replacements themselves are just like they should be. I told my regular doctor but she didn’t think it was the shot – I do for sure know it was. I take morphine for my chronic back pain and that hasn’t even touched the pain. I am not hardly able to get around it has changed my life so much. I am still in hopes that something can be done. Can anyone suggest anything? I do take plenty of calcium everyday because I know if I didn’t it would cause even more problems. After the 6 months is up will my symptoms ease up as I will not take anymore. I hope someone can help shed some light on this. I think it should be taken off the market. I would be willing to sue the company if it didn’t involve my doctor as she thought she was doing the right thing. I am not mad at her. But I am mad at the FDA and the Prolia Company for putting this bad drug on the market without more testing.

  4. norma Reply

    about 3 months ago i got the prolia shot and the next day all my limbs wents numb and the pain was crazy i called my doctor and she said i was having a savior allergic reaction to prolia to drink water and try to flush med out of my body my lower back was killing me so i was to take an mri that did show nerve damage so theres was nothing else she could do for me i was stuck with pain and no where to go i went to my nerologist and asked for to get an mri of my head cause i keep getting something like if someone turns on a lite switch and all of a sudden from my jaw up my face my finger my legs and toes all go numb at the same time and i have to stop what im doing cause i cant function and that happens oh so many times a day i cant even tell u and no one no how long this will last or if this is going to harm us even worse in the future they have only been around 3 yrs we r the experiments im in if theres a law suit they need to be stopped

  5. Esther Reply

    I have taken Fosamax, Reclast (only once) and Prolia and now I have Osteo Necrosis of the Jaw.

  6. Pattie Reply

    I had prolia injection 10 months ago & wish so bad I had known of the side effects before taking! NO ONE should take the risk, it is not worth any benefit you might get from it. I immediately had nausea, vomiting , fever, chills. Then severe fatigue, which turned out to be severe low blood calcium. Bloody stools, severe pain in all major joints. WORST!! Is my jaw pain, it feels like my teeth will fall out if I bite hard. Now my liver is shutting down! I have a 17 year old and a 10 year old and thanks to the non reporting of the horrible side effects I am unable to care for my family as I desire!!

  7. Elaine Reply

    I have been on Prolia for several years. In August my femur broke, and I fell. I had to have surgery and a rod was inserted. I will not be able to walk for several months and am in pain.

  8. Lisa Reply

    My mother aged 79 was given prolia injection one month ago. At the time of injection she had moderate dementia but has declined rapidly since. Maybe if that were the only change we could simply contribute it to existing condition. Unfortunately she has suffered extreme muscle cramping, bone pain and nausea and vomiting. I was told by physicians nurse that it was impossible that Prolia had anything to do with new symptoms despite the fact that the warnings on Prolia packaging lists each of the new symptoms as possible side effects. She was very defensive and implied that I was not properly caring for my mother. The physicians tactics for the necessity of the injection was very aggressive despite her obvious concern that my mother was significantly diminished since her last visit.

  9. Melle Reply

    I began taking MONTHLY Xgeva injections late last Summer (2013) as added chemo for Metastatic Breast Cancer (now in bladder wall & bone)- After taking Xgeva thumb joints began to ache constantly when moved..but stayed SORE…then other joints began to hurt really bad- At first I blamed it on Arimidex, the chemo (aromatase inhibitor) pill I take each night but I had been taking that since late June of 2013..& it pain didn’t start UNTIL taking Xgeva- Taking calcium & Vit D3 is encouraged b/c of Arimidex lowering calcium- I took the supplements but clearly Xgeva added worsened pains- I learned that the reason it’s given to bone loss patients ONLY TWICE A b/c the drug is SO BIGGIE & TOXIC..that even 6 months later..some of the drug is STILL IN the body & liver- I can understand that..b/c it took 5 months of NOT taking Xgeva..for my thumb joints soreness to be almost Gone…then finally NO more pain after 8 months off Xgeva- I lost ability to bend one thumb..& I blame Xgeva for that.. I am convinced that Xgeva led to depletion of Vit K so I developed bad calcifications too- Stints in both ureters became so “cemented” in…after taking Xgeva ..that I had to have several rounds of Lithotripsy to the stint/ureters areas- I also had a terrible experience with a Root Canal tooth that went bad after taking Xgeva for several months in a row- There are numerous reports of Jawbone & tooth painful experiences after taking Xgeva and/or Prolia..just AS I LOST that tooth (old Root Canal)- These drugs should be BANNED…& NOT encouraged by briefcase toting salespeople for drug companies convincing Drs to insist that their patients TAKE these dangerous drugs…I say…BAN THEM !

  10. Jennifer Reply

    I got the prolia injection September 20, 2014 I’m about 4 months into this shot. The day I received the shot hours later I was unable to move due to my body locking up then so much pain. My throat closed shut face swelled up couldn’t hardly breath felt like someone punched me on the side of my face. Went to the ER heart rate 220 blood pressure 190/130 the Dr said I had a bad sinus infection and was sent home. Next day back at the doctors office where I go now at least once a week have had thrush strep throat now 4 times and been on 4 rounds of antibiotics which my body is immune too. The doctor put me on prednisone to take the swelling down after 3 injections of steroid injections. Last week the doctor tried to take me off the prednisone due to it weakens your bones but I went right back to my throat swelling shut again. This is the worst I have ever been in my life. I am 33 years old and I can’t even hardly get out of the bed now. I went from being very active and working full time to being in the bed. I’m a single mother and this has been the worse I hope and pray they take this medication off the market. I now have to go to the hospital today to be placed on a heart monitor for 24 hrs then Monday I go back to have a echo test on mu heart. My face and arms stay numb all the time. I’m just trying to live this is so scary! Never ever get this horrible shot.

  11. Michelle Reply

    I had a shot of Prolia going on 10 months ago and have been unable to breath, have severe pain in back, heaviness in chest, jaw pain, headaches, nausea. I have contacted the manufacturer several times stating I had a severe reaction to the injection and was told to see my doctor. The doctor that administered the injection told me it was not a side effect of the shot. All of my symptoms are listed as severe side effects and to see my physician. I have spoken to him several times and he has not addressed the problem.

  12. patti Reply

    I’ve received 3 Exgeva shot’s & after each one I’ve had Joint issues.
    Fractured Hip Resulting in 3 hip surgeries due to not healing & necrosis.
    Also upon receiving my 3rd shot my blood work was normal & 6 wks
    later I was hospitalized w.Potassium level of 2.3 (Near Death) & very
    low Calcium levels. Severe dizziness chest pains Irregular heart beat.
    I have torn Rotator’s in both arms. Weak knees. None of this B4 Exgeva
    Please take RX off the market as Dr’s won’t recognize the side effects.

  13. Kenneth Reply

    I received 1 Prolia injection around February 28 2016 . This medication was recommended for bone build up (calcium) after having a hip operation (around October 2014). That operation immediately started causing thigh bone pain. After several visits to the doctor without relief from constant pain of my thigh, the doctor recommended Fosamax which I refuse because of the warnings . No one gave me warnings on the side effects of Prolia shots .

    The very next day after the injection I began having chest pain, shortness of breath and breaking difficulty. I call ask a nurse and they told me to get to the nearest hospital because of the vomiting and severe chest pain from there I want transported to another hospital and was given a triple bypass operation. I cant tell you how I regret taking Prolia. And I still have severe pain in my hip and thigh

  14. Gena Reply

    I had hormone related breast cancer (stage 1) in May 2013. After I had a lumpectomy and radiation, I was put on Arimidex and started having Prolia injections every 6 months, according to my oncologist’s suggestion to help prevent osteoporosis. I am having bone pains the whole time and initially thought that the oestrogen deprivation was responsible.
    After having the 3rd injection I had teeth problem, had severe toothache and had to have the nerves of the tooth removed, although the tooth had no other problem. In March 2016 my bone pain got much better, but in early April it was time for my 4th Prolia injection. After I got it I have severe back pain, hip pain and my right thigh is hurting. My left knee that has a meniscus rupture feels like it’s bathing in poison. I have sleep problems as I hurt every time I want to turn in bed and there are times I wake up crying and have to get help to get out of bed.
    Funny thing is I have no osteoporosis, but decided to continue the drug, against my good judgement, because I read that it might help to prevent possible metastases to the bones. And now it feels like I have one, which I don’t! Of course, that was the last time for me, will not take it again

  15. Angela Reply

    I was diagnosed with breast cancer in 2012.
    I had mets to my spine in 2014. I broke my back and had it repaired. They put me on xgeva to strengthen my bones. After each injection I had very achy joints it hurt to get up out of bed and my back would feel like I started my surgeryrecovery over again. I was on it for about 2 years. I. Received one injection each month.
    Just two months ago, a piece of one of my teeth just crumbled off!
    Ironically they asked me on my following appt if I had and teeth problems or dental work recently. Sure enough. They stopped the shot and didn’t even address it at my last appt.
    I will follow up with them again.
    I would like a lawyer to look into this on my behalf as well.

  16. Rose Reply

    My husband developed osteon necrosis of the jaw from xgeva. This medication should be taken off the market. At first he was treated for a dental absess but now his jaw bone is dead and they can’t do anything to fix it.

  • Share Your Comments

  • Have Your Comments Reviewed by a Lawyer

    Provide additional contact information if you want an attorney to review your comments and contact you about a potential case. This information will not be published.
  • NOTE: Providing information for review by an attorney does not form an attorney-client relationship.

  • This field is for validation purposes and should be left unchanged.