Prolia Side Effects Increase Risk of Low-Trauma Fractures: Public Citizen

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A prominent consumer watchdog group is warning that the Amgen bone drug Prolia could increase the risk of sudden bone fractures, which may occur with little or no trauma at all.  

In the latest edition of Public Citizen’s Worst Pills, Best Pills Newsletter (subscription required), the group indicates that there have been concerns over the potential side effects of Prolia since 2009, a year before it became the first drug ever approved by the FDA for the treatment of postmenopausal osteoporosis.

While warnings about the risk of femur fractures from Prolia have been issued in Canada, similar warnings have not been issued by the FDA in the United States.

As a result of the risk, Public Citizen is urging consumers and health care providers to avoid Prolia, placing the osteoporosis drug on it’s “Do Not Use” list.

According to Public Citizen, Prolia (denosumab) interferes with bone metabolism and the body’s immune system, resulting toinatypical bone fractures and breaks that happen spontaneously without the usual trauma, like a fall, needed to break a bone.

According to Amgen, Prolia fractures have been confirmed among patients who are part of an ongoing study to extend the use of of the drug for postmenopausal osteoporosis. The fractures appear to occur in one out of every 10,000 patients that use the drug. In most cases the fractures produce a dull, unusual aching pain in the thigh, hip, or pelvis area.

Public Citizen looked at data from the clinical trials and found that in one study those taking Prolia for three years saw their risk of hip fracture triple, while those taking a placebo saw their hip fracture risk actually drop. The newsletter notes that the absolute difference in fracture risk between those taking Prolia and those taking a placebo were relatively small; a difference of about 4.8%.

There were other concerns with the drug as well that were known before the FDA granted approval, Public Citizen maintains. The group claims there were concerns over infections, dermatologic adverse events, as well as problems linked to the suppression of bone turnover; including atypical fractures, osteonecrosis of the jaw and delayed fracture healing.

Atypical Fracture Problems Affect Other Bone Drugs

Many of the same problems have been linked to bisphosphonate medications, a family of bone drugs that includes Fosamax and Zometa.

Merck & Co. currently faces hundreds of Fosamax femur fracture lawsuits that have been filed by individuals who claim the drug maker failed to adequately warn about the potential risk of problems.  Complaints allege that side effects of Fosamax may weaken the ability of the femur bone to repair itself from microdamage, increasing the risk of a sudden femur fracture.

In October 2010, the FDA required the Merck and the manufacturers of other bisphosphonate medications approved for treatment of osteoporosis to add warnings about the risk of sudden femur fractures. Since then, information has been provided in a Medication Guide distributed with each prescription for the drugs, warning consumers to contact their doctor if they experience new thigh or groin pain, which can occur weeks or months before a complete femur fracture occurs on the osteoporosis drugs.

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  1. Donna Sue Reply

    Teeth needs pulled Dentist refused said i had onj. ?

  2. Jacqueline Reply

    Had taken Prolia injections fora few years 2013 and had fractured my back raising my arms on 2013 and now having a hip replacement this month. Had two knee replacements 2010 and 2012. Had parathyroid surgery 2014. Hip was ok 2014 and now it’s bad. Quit Prolia when Dr retired and new Dr would not do it. I am suspecting the Prolia Made everything worse.

  3. Jennifer Reply

    I received a shot of Prolia around the first of Dec. 2015 About 4 weeks later I woke up with pain in my left knee The pain kept getting worse. MRI showed insuffiency fractures of the tibia plateau and inflamation. After another month my right knee became inflamed. MRI showed bone marrow edema and tendonitis etc I cant walk without crutches. The Dr wants to do a partial knee replacement on my left knee. and see what develops with the right knee Until I had the shot of Prolia I was not having any pain in my knees

  4. Sandra Reply

    I had the first shot in December 2013. I did not take the second shot until March 2015 at the Dr.s insistensistance.
    Within two weeks I had a reaction. My ear was on fire and oozin,
    There next morning my face was swelling as weh as my eye.
    Went to the Dr. Gave me antibiotics. The next evening I was in the
    Emergency room with infusion of antiibotic.
    Every two months
    I have a breakout. As time goes on I have more system.
    After over a year my doctor sent sent me to an infectious daseae
    And she called Amgen. Amgem then calllled me and said that they were side effects and had now answers.
    Last time I went to my doctor he said he just did not know what
    To to and sent me to Virgina Mason hospital in Seattle.
    The only thing she could say is take antibiotics when it brakes out.
    I have already taken more antibiotics.
    I am miserable and can’T believe they would give people
    This stuff!

  5. Lyn Reply

    I had one injection of prolix in December of 2014, has the second scheduled, when I began experiencing pain in the left groin area. Within ten days I needed emergency surgery for an unexplained femur fracture, five weeks of inpatient rehab, five months in a wheelchair, with zero weight bearing on the left side, three months with a walker, permanently needing a cane. The only change in meds? Prolia. Thanks Blythe Danner. The commercial was instrumental in my asking my doctor about trying the drug since I wasn’t on anything to prevent bone loss or fractures.n

  6. Merna Reply

    I was taking Prolia 4 years. Since then I had a triple fracture in the pelvis, fractures in foot, broken femur and arm and now I have 6 compression fractures in my spine. None were caused by trama. I am thinking of filing a law suit. This drug has major risks in my opinion and I think strong warnings should be issued before prescribed.

  7. Pam Reply

    Prolia injection…three spinal fractures one year later…wondering if class action lawsuit for this.

  8. Shirley Reply

    My heart goes out to each person responding here! It is obvious reading these women’s comments that the FDA is not doing a very good job about protecting us!!! Knowledge is power. Please read and investigate ANY drug your Dr. prescribes before you take it. Go get a second opinion. Our health is too precious to be some drug company’s guinea pig!

  9. Brenda Reply

    Took several Prolia injections and developed severe back, hip and leg pain. Called oncologist and was informed to stop Prolia. Would not recommend as the side effects seem to be worse than the presumed benefits.

  10. patricia Reply

    I had 5 prolia injections/6 months after the last one I experienced vertebral fractures & needed 4 kypho plasties/they want me to take forteo now but I am not going to do it/can cause bone cancer in lab animals & should not be given to people with history of radiation treatment/I have been treated with radiation for bone cancer.

  11. Beth Reply

    I had two Prolia injections in 2016. I had terrible all over muscle pain and joint pain during the 12 month period this drug was in my body. I refused to get a third injection which was due in June of 2017. Since discontinuing Prolia I have had 5 spontaneous vertebral fractures. This last one is at T 12 and especially painful. I have been in constant pain for over six months now. As soon as one fracture starts to heal I have another one. Four are lumbar and the latest one is T12.

  12. Sylvia Reply

    I had my first injection 4 weeks ago and had I read the many reviews of Prolia, I would have not taken the drug, despite my M.D.s urging that it is a good,effective med. I was not exactly feeling terrific a month ago, but since the shot, my entire body seems to be failing. I have constant mild to severe nausea; pains in my legs, hips, hands and spine that I’ve never had in my life. My skin is in constant pain/outbreak of hives and itching so bad on my entire body that it blistered in areas and peeled due to excessive scratching. Now a UTI has begun. I had read the entire insert material and was aware that side effects might occur but the side effects are increasing as time goes on and the fact that there is no way to purge oneself of the medication is frightening. I feel very sick and apparently helpless. I regret having taken this product ..even though the doctors all suggest it’s “the best medication going” and they know of its side effects but of all their patients on the drug…know of no one who has experienced any problem. REALLY?

  13. Barbara Reply

    I made the mistake of allowing my new doctor to administer this drug to me , before I did this I asked about the side effects? :Oh the benefits will outweigh the side side effects” About a week after the injection I felt really achy and went on to have most of the negative effects other here have reported here, but not bone breakage, guess i was lucky. /when I got so sick this doctor said I should have “read up on it beforehand” She lied because I had no opportunity to look ant a computer and drug fact sheet was not given to me before she injected me! The most horrible thing was to have this awful poisen in your system for 6+ months and nothing can be done to purge it! It has now been just over a year and I still think it is effecting me and my health. If you are reading this please do not take this drug!!

  14. Catherine Reply

    After going off Prolia, I’ve had 10 disabiling spontaneous vertebral fractures with delayed healing. Also, developed breast cancer.

  15. Marilyn Reply

    After taking two injections of Prolia at the recommendation of an arthritis specialist, I have lost a tooth that broke off at the gum line. I have been seeing the same dentist for years with 6 month cleanings and checkups which my last one was less that 4 months prior to losing this tooth. I was diagnosed with osteoporosis several years ago after falling and causing a vertebrae compression. The doctor at that time recommended Forteo and for follow-up to see an osteoarthritis doctor which I did. After re-locating to Jonesboro, he referred me to the doctor who insisted that Prolia is a safe drug. I do not intend to continue getting these injections. I think the risk outweighs the risk.

  16. Margaret Reply

    I took PROLIA. For almost 4 years. I was late with my last shot. I ended up with 8 compression fractures. 3 weeks in the hospital. Still recovering at home.

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