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Xgeva, Prolia Bone Drugs Linked to Deadly Low Calcium Levels

  • Written by: Irvin Jackson
  • 9 Comments

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.

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9 comments

  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 monthly..my 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 YEAR..is 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 !

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