Prolia and Xgeva Side Effects May Include Heart Rhythm Risks, Australia Warns

Drug regulators in Australia are warning that the bone drugs Prolia and Xgeva, both of which use the active ingredient denosumab and are also available in the United States, could cause users to suffer abnormal heart rhythms linked to lowered calcium levels. 

Australia’s Therapeutic Goods Administration (TGA), part of the nation’s health department, issued a medicines safety update on August 11, indicating that side effects of Prolia and Xgeva may increase the risk of QT prolongation.

The TGA warning came in the wake of an assessment of adverse event reports submitted to Australian regulators. QT prolongation can cause heart rhythm problems such as irregular heartbeats (arrhythmias) which can cause serious health problems or even death.

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While both use denosumab as the active ingredient, Prolia is given twice a year for the treatment of osteoporosis. Xgeva is used once a month to prevent skeletal problems in adults diagnosed with metastases from solid tumors.

Australian regulators believe the prolonged QT intervals are a side effect of hypocalcemia, or low calcium serum levels in the blood. Hypocalcemia is already listed on the drugs’ labels as a risk, but the TGA notes that QT Prolongation is not, nor is the label clear that there is a risk of severe levels of hypocalcemia.

The drugs’ product information documents in Australia have been changed. It is unclear whether the labels and product information guides will also be changed in the U.S. or other countries.

Denosumab is a monoclonal antibody that was first approved in June 201o for Amgen, Inc.’s Prolia, and then later approved in November 2010 as Xgeva, again for Amgen. It inhibits the development of osteoclasts, resulting in decreased bone resportion and increased bone density.

9 Comments

  • BelindaJune 29, 2023 at 7:36 am

    I've been onprolia for 6 years. I'm getting heart arithmia on & off. Pain in my calf ,right ankle which feels like bone pain. I've had xrays ,ultrasound nothing is wrong. But I'm unable to walk after sitting, pain in my legs, feet, shoulders. I can't live my life with this constant leg pain. Looking at comments I don't no if I should stop prolia, with the comments talking about fractures in vert[Show More]I've been onprolia for 6 years. I'm getting heart arithmia on & off. Pain in my calf ,right ankle which feels like bone pain. I've had xrays ,ultrasound nothing is wrong. But I'm unable to walk after sitting, pain in my legs, feet, shoulders. I can't live my life with this constant leg pain. Looking at comments I don't no if I should stop prolia, with the comments talking about fractures in vertebrae. I already have 5 fractures in my upper spine.

  • MargaretJune 24, 2023 at 12:12 pm

    My Primary Care, Cardiologist and Electrophysiologist suggested I go ahead with my first Prolia injection even though I have a history of high pulse rate. Twelve days later I was admitted to the ER with a heart rate of 187. The pulse rate was ranging from the forties to 187. They had to do a cardioversion to save my life and I have had problems ever since. Seven years ago I had a heart ablatio[Show More]My Primary Care, Cardiologist and Electrophysiologist suggested I go ahead with my first Prolia injection even though I have a history of high pulse rate. Twelve days later I was admitted to the ER with a heart rate of 187. The pulse rate was ranging from the forties to 187. They had to do a cardioversion to save my life and I have had problems ever since. Seven years ago I had a heart ablation and have been fine with medication until Prolia. Proceed with extreme caution before making this decision.

  • KayJanuary 10, 2023 at 3:52 pm

    Have to see a heart specialist due to irregular heartbeat??? Is it a coincidence?Never had it prior. Been on Prolia three years.

  • ShannonOctober 6, 2022 at 10:24 pm

    Took a year of Prolia… now I’m in a fib Seeing cardiologist 3 shots

  • PatriciaSeptember 28, 2022 at 2:21 pm

    I have taken one dose of Prolia I have developed every complication from this drug. I now have a cardiologist appointment to review all my heart arrythmias

  • PatriciaSeptember 27, 2022 at 11:08 am

    I have had all the most dangerous side effects of being administered the injection of Prolia now having to see a cardiologist as I have severe heart arrythmias. I did not want this injection but my Dr insisted as I had broken my wrist I requested a bone density which I had but he would not wait for the results, I did not need this injection

  • DoloresMay 16, 2022 at 9:51 pm

    About a year, or more ago, I took a Prolia Injection, S.C. in my left upper arm. After I walked out of the doctors office, the injection site became painful, which is something I hadn’t felt before with previous injections. I guess it was a couple hours later, I felt the sensation, like trickling of fluid in my soft tissues —- up to my left jaw and, also, up to my shoulder, and down my left side.[Show More]About a year, or more ago, I took a Prolia Injection, S.C. in my left upper arm. After I walked out of the doctors office, the injection site became painful, which is something I hadn’t felt before with previous injections. I guess it was a couple hours later, I felt the sensation, like trickling of fluid in my soft tissues —- up to my left jaw and, also, up to my shoulder, and down my left side. As time went by, I felt the trickling sensation and minor pain extending further, from my left side thru my Left hip area, and down to my left thigh. With more time lapse, the trickling sensation and minor pain continued to my left ankle, but not past my left ankle. I did not feel the trickling sensation or pain on my RIGHT SIDE anywhere. These sensations established their path over a several days period. I called the drug manufacturer and spoke with a representative. The representative told me that in clinical trials other people had experienced the same discomfort, but none had experienced it unilaterally (as I had) —- that their trials experienced the discomfort bilaterally. I advised my Rheumatologist before my next 6 months injection. I have received several injections since then, without trickling sensations —-and only left Upper arm and shoulder medium pain. Currently, I am having a bothersome discomfort at my left ankle and foot ( not relieved by Acetaminophen 500mg, for about 2 1/2 -3 weeks, now). Suggestions, please. Thank you. Dolores

  • Patricia EverestMay 14, 2022 at 8:00 am

    I had my first injection six months ago,and about two hours later my heart rate starting going up. It stayed between 140 and 149 for almost three hours,then began going down. By the time I got a reply from my DR,it was 83. He said if it went up again to go to the ER. My cardiologist,I have cardiomyopathy following chemo 16 years ago,said it should not have raised my heart rate. My DR wants me to[Show More]I had my first injection six months ago,and about two hours later my heart rate starting going up. It stayed between 140 and 149 for almost three hours,then began going down. By the time I got a reply from my DR,it was 83. He said if it went up again to go to the ER. My cardiologist,I have cardiomyopathy following chemo 16 years ago,said it should not have raised my heart rate. My DR wants me to try one more injection on May 18th. If it happens again,then I won’t have another. I am a little nervous about it.

  • VenitaFebruary 21, 2022 at 3:13 pm

    On 02-21-2022 at around noonI had a prolia injection. Early the next morning I had a rash, swollen glands, and mild nausea with headache. I went to the E.R. I was given medication to help. Initially everything was ok. I've felt very jittery with mild headache and nausea. I still feel like this. Today is 02-21-2022

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