Prolia Lawsuit

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Increasing evidence suggests that side effects of the osteoporosis drug Prolia may increase the risk of hip fractures, femur fractures and other bone fractures, which typically occur following minimal or low trauma events.

PROLIA LAWSUIT STATUS: As a result of the drug maker’s failure adequately warn about this risk, the potential for Prolia fracture lawsuits are being evaluated by product liability lawyers.



OVERVIEW: Prolia (denosumab) was first introduced in 2010, as a treatment for osteoporosis. It was also the first drug every approved by the FDA specifically to treat postmenopausal osteoporosis. However, early on it was linked to an increased risk of bone fractures.

According to the consumer group Public Citizen, there were concerns over Prolia side effects dating back to at least 2009; a year before it was even approved to be sold.

In 2012, Health Canada and Amgen released a Prolia bone fracture warning letter, which was designed to alert Canadian users to an increased risk of atypical femur fractures that may occur with little or no trauma to the thigh bone; the thickest, largest, and purportedly strongest, bone in the human body.

Similar warnings were placed on Prolia sold in Europe. However, Amgen has decided U.S. consumers of Prolia do not warrant the same consideration or label warnings, despite the fact it is the same drug being sold in the U.S. as is being sold in Canada and Europe…just without those same warnings about the risks of bone fractures.

In 2013, the consumer watchdog Public Citizen added Prolia to its list of pills consumers should avoid, placing the drug on its “Do Not Use” list. Public Citizen noted that not only did Prolia triple the risk of hip fractures, femur fractures and other bone problems, but there were also concerns over infections and dermatologic adverse events.

In April 2019, Public Citizen petitioned the FDA to add a black box warning to Prolia over the risk of bone fractures. It is the most stringent label warning the agency can require a drug to carry.

FIND OUT IF YOU MAY QUALIFY FOR A PROLIA LAWSUIT: As a result of the drug manufacturers’ failure to adequately warn about the risk of fracture problems, Prolia lawyers are evaluating whether users may be entitled to compensation through a product liability lawsuit.

To request a free consultation and claim evaluation to determine whether you, a friend or family member may be entitled to financial compensation through a Prolia lawsuit, submit information about a potential claim for review by a lawyer.

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  1. Andrea Reply

    After one shot of Prolia, I got psoriasis and severe pain in neck, shoulder, both legs, both hips. As a result I went to a chiropractor, an orthopedist, had an MRI for my shoulder, had physical therapy, took muscle relaxants and too much Advil, had acupuncture, went to the ER because I thought the back pain was maybe a kidney stone (it wasn’t) but the pain was so terrible they gave me intravenous Delaudid (a very heavy pain killer). Went to a dermatologist for the psoriasis on my face (now gone). And then to be told (I’m sure the drug maker purposely says this) that I can’t stop taking it ever or will have spinal fractures. Drug should be taken off market and doctors should be required to warn patients of these horrible side effects that are way too common with Prolia.

  2. Karen Reply

    Had first injection may 19..had headaches…vertigo saw nurologist…mri…ear infection. ..pain in left hip…continuing utis…burning mouth and lips .dr always denies its prolia….

  3. Mavis Reply

    After one shot my body was a total wreck I still suffer my knees hurt so bad I can hardly walk my spine hurts if I stand for about 5 mins. my eggs got much my mouth is always sore there’s not a part of my body that’s not affected by that shot

  4. Janet Reply

    Jan’s Prolia story

    I have said EXACTLY the very same thing- I have all those issues but they are now at a level 3/4 and flare in sequences to a 7/8. 8 hours after my Prolia it all started –
    12- 24 hours later I was in bed – crawling to the bathroom because my feet were so curled I could not walk … I had open sore rash on my face sizes of dime to Nickles- I was in bathroom 24-7
    , vomiting, dizzy, huge mouth sores and a large fleshy mass in roof of my mouth. Severe headache and then the COPD cough- Coughing so much my abs and chest hurt… Dry skin and eyes – nails flakes off… hideous lady parts itching… eyes felt like cotton balls, and peeing and pooping myself- gastro issues , constant UTI , severe … lost much of my hair- bought a wig- hated wearing it… and my teeth issues- that was January 2015. I have said many times it ages me 10 years or more. And if it aged my outsides what did it do to my insides?
    Had to Quit my job 3 weeks later – I couldn’t manage to stop crawling and being in the bathroom until at least noon or later each day.
    Sobbed and cried by myself daily… – we got Coco a month later and she saved me. She got me out of bed, on afternoon walk and out socially… and kept me company. I owe her my life… Went to Mayo Clinic by myself with Mister for 9 days plus weekends …
    They addressed each single medical issue and stopped the treating my body as individual pieces to a whole body allergic and flared by Prolia. My doctor here followed their protocol to this day.
    I had rx for all of the above and
    My house is still full of all the rx. I can’t get rid of them just “in case” I need them.

    All due to one ridiculous PROLIa shot. Triggered every single autoimmune issue in my dna to attack my body all at once.

    I read on my Prolia sites people who are far worse … my hearts aches for them. And when I hear of someone’s family member I vow to share my story to not take that drug.
    I am a case study per Mayo Clinic for Fda and Amegen has my file as well. One day I hope to hold them accountable along with millions of other people.

  5. Marianne Reply

    I stopped Prolia in February. I developed ringing in my ears and was afraid it was a side effect of Prolia. I was NEVER told that stopping Prolia could set set me up for vertebrae fractures, even though I specifically asked if there were any problem with stopping the shots. I developed a T6 fracture in May, suffered though the recovery and now have another one. The pain is extreme. I called the doctor’s office and told the employee who seems to manage the Prolia patients about my fracture and that my PCP showed me the information about stopping the shots causing these fractures. She had no idea this could happen and even said she needed to let people know who hadn’t gone in for their shots because of Covid. I was advised that by a different doctor that I needed to go back on the shots to try to prevent the fractures, I got another shot but am very afraid of more problems! When I started the shots I was told about possible jaw problem and femur fractures, but told the chances of problems were remote, I was NEVER told that once I started these shots I could not stop! This just shouldn’t have happened.

  6. Beth Reply

    I had 7 rebound vertebral fractures after discontinuing Prolia. I wasn’t warned about this possibility by my doctor or Amgen. They occurred in 2017 through 22019. They were extremely painful and debilitating. I am permanently semi disabled now as a result of these fractures.

  7. Deanna Reply

    I have been taking Prolia shots about 4 years now. I have suffered extreme back pains . I have been to several Othopedic Doctors and surgery is out of the question because I developed severe osteoporosis of the spine. L-2 down to S-1.
    Also, I have itching of the neck, ears, and scalp.
    Also bathroom issues.
    I’m afraid to stop because of the warning that the company said.

  8. Minette Reply

    I had my first injection on 1 May 2020. I am now suffering from vertigo. Extreme tiredness. I was not told of any side effects when given the injection. Never told my immune system could be compromised. My parathyroid reading went to 20 and my calcium is decreasing. I was never told this was chemotherapy. Suffering anxiety as to the future as I have CKD and coronavirus is escalating in my state.

  9. Tracy Reply

    Im female 53 – diagnosed with osteoporosis March 2019 and was given the prolia injection only once – pain in joints, hip, feet, fingers – everywhere basically! shooting pain in arms, anxiety, hair loss, vertigo 🙁 I didn’t go back for a second shot but a few months later thought I better do something to prevent further bone loss. Doctor gave me script for Risedronate, took 2 tablets over 2 weeks, I noticed my mouth area and lips tingling and feeling numb. I’ve not had another tablet since. 3 weeks later my mouth and cheeks lips are still numb and I’ve had an ear ache with ringing, shooting pain in arms and joint pain. The stress has caused anxiety and I’m on a down spiral, now I’m experiencing memory loss and I feel like I’ve aged about 20 years – Don’t know where to turn at this point. Tracy

  10. Tracy Reply

    Pls contact me if there is a class action for prolia 2020

  11. Eileen Reply

    When I completed Chemo and Radiation, my Doctor recommended Prolia to prevent fractures due to Letrazole medication.
    After 1 shot of Prolia, ( I refused any further injections) my bone and muscle pain have continually worsened. My jaw gets “stuck” and is painful. I did not have any of these issues before the Prolia. I actually felt decent for the first time since the end of Chemo then came the Prolia. I had a lung biopsy for a chronic cough (not sure if related) and was asked if I have Rheumatoid arthritis. The blood test showed Rheumatoid indications. I never had Rheumatoid indicators, not even with Chemo labs done every 3 weeks.
    I have taken steroids for seasonal allergies, heat rashes and then ibuprofen for this pain which helped. Now I’m having GI flare ups and was told not to take ibuprofen. I can hardly walk without pain in every joint, bone and muscle. My arms, hands, feet, shoulders, knees-all are effected.
    Maybe a broken bone would be less painful and would possibly heal. Not sure this will ever
    wear away.

  12. Doreen Reply

    I started Prolia two years ago. I read about possible side effects, but was never told I could not go off this drug. The drug caused a substantial rise in my cholesterol, so I went on a vegan diet and was able to lower it somewhat. I do not want to continue taking this drug, will be telling my doctor I’m discontinuing it before my next injection. I do not want to take any other drugs for osteoporosis, and I feel that I was not given proper information about long term effects and not being able to stop taking it without risk of fracture. I feel duped.

  13. Inge Reply

    I have had one shot prolia I resisted it for a long time after reading horrible reviews I has a stress fracture in my foot Was advised by chemist and a prior doctor You only read the bad stuff online

    So I took a shot My left arm is extremely painful And fingers and thumb tingling all the time Pins and needles and one day extreme pain inside the bone of left arm

    Any advice please Good or bad
    I’m worried

    I am not going to take another shot I’m terrified

  14. Barbara Reply

    I have had one shot……will be my last!! I had pain from before but this has put me to my knees!! All over I hurt..going up stairs I feel like I’m going to snap in half!! Itching in areas, extreme tiredness, some days I can’t even stand for more than 2-3 minutes!! My back, neck, shoulders, knees, ankles, arms, hands…….did I miss anything…. all ache!!! I don’t think all the doctors know what this really does to your body!! I’m in month 3 and can’t wait till this is out of my body!! Should have been more up front about the side effects……can’t see how FDA approved this…probably some greased palms in there!!! Can’t even trust them anymore…..not about health but money!!!

  15. Jeanette Reply

    Had Prolia shot Oct,19,2020 and by Thanksgiving was having pain in both arms and hands and the17th of December,I left for California,just taking Advil.My right hand ,fingers were numb, then hand would tingle and sharp excruciating pain happened several times day and night keeping me awake.And backaches making it hard to get up and down .My left hand ached most of the time and was having charley horse cramps in both legs and feet.No pain medicine helped.When I returned home, went to my doctor , which sent me for exray of right shoulder, which came back as osteoporosis. Sent to have EMG done both arms and hands.Right hand came back as carpal tunnel and left hand as nerve damage .couldn’t wear watch or rings or wear a long sleeve that touched my wrist. Also went to Ortho Neuro for arms, had exrays, sent for therapy.After one session ,every thing shut down ,because of virus.Couldn’t have hand operated on,but he gave me a shot in the wrist,
    which helped plus Gabapentin.from family doctor.I’m still having problems after almost a year.Was never told of side effects,but knew the Prolia shot is the cause of all the pain I’ve had.I was a healthy woman of 83 years old ,on record as seeing my doctor for a sinus infection once a year. I will not ever take the shot again, and believe that a shot that was supposed to help, caused me the most pain I’ve ever had in my life.I would like to be informed if there is a lawsuit in the future.

  16. Otis Reply

    Had first injection in March, 2020. I have suffered shoulder pain, back pain, left and right hip, both leg calfs, vision problems, numbness in both hands, and unable to get sleep. The Dr tried to convince me it is not the Prolia. No way. Tylenol or Aleve doesn’t give relief. I have called FDA and filed a report. Walking with a cane for balance. No more injections.

  17. donna Reply

    I took my first…and last shot August 2020. In less than 3 weeks i started to have side affects, but i didnt put it all together till this week. When i went to see my oncologist, the one who prescribed this crap, she basically blew off my fears as stress, my age, etc… did set me up with a back xray, which showed osteoarthritis in my back. Anyway when my sister urged me to check out the Prolia, but util i was checking on drug interactions, i had never given it a second thought.
    I couldnt believe all that i found. All but 2 of my symptoms for the past 4+ wks were there. The shin pains that keep me up all night, the jaw pain where I cant even open wide enough to eat… the flu like feeling coming and going several days a week. There was numbness in my hands and dizzy spells at home and work. Some day i would call in because i couldnt even stand up with the pain in my feet and legs. There was stabbing pain in my ribs at anytime, for no apparent reason. This is crazy. This should be taken off the market.

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