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Prolia Lawsuit

Austin Kirk

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Increasing evidence suggested that side effects of the osteoporosis drug Prolia could 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, potential Prolia fracture lawsuits were evaluated by product liability lawyers.

AboutLawsuits.com is no longer reviewing new claims involving Prolia side effects. This page is maintained for informational purposes only.

Prolia Lawsuits

MANUFACTURER: Amgen

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.

Tags: Amgen, Bone Fracture, Osteoporosis, Prolia

227 Comments

Alice
P.s. from Alice. I also had a hip replacement that was also a side effect from Prolia. Can this drug be reversed now that I stopped taking it?…….my poor husband thought I was crazy crying all the time in pain, and he has to help me do my housework a lot of times. Thanks Prolia….
Alice
I trust my doctor very much and when he told me Prolia was good for my osteoporosis as I was in severe back pain, I agreed to get these shots (4) in the last2 years. I immediately began to get pain in my both legs, but my dr said it was probably arthritis and to keep my aqua fitness and something for pain…. I researched Prolia side effects and yes it’s the source of my pain so severe I can hardly walk. Please tell me someone that on stopping this medication I will regain my feelings in my legs as they are very numb as well as painful. My back is also worst than ever as well…..alice
Beverlee
I have taken Prolia for several years and now I am very concerned about my teeth and jaw. I have had 3 dental implants (all fine before Prolia) fail. Each of these implants have had to be removed and I am not sure what I will have to do at this point. I have had a horrible time with constant jaw pain, now have TMJ (not present before the first implant failed) and also much difficult with chewing and eating.I have had significant weight loss and did not have any extra pounds to lose. The daily, constant, significant facial and jaw pain is at times – unbearable. I have tried to have Botox injected into both jaws, which has data that supports this can stop and eliminate the daily pain, however my insurance company will not approve it.
Elsa
I regret the day I was given the first and only injection, November 2014. To this date I’m suffering from the effects. The doctor did not bother to do a complete history and gave me the injection on Tuesday. By Sunday I was dieing of pain lower left abdomen. I knew I had diverticulitis for years but never bothered me. I think that because this injection lowers your immune system, anything can become infected and abcessed. I needed three surgeries with the colostomy and presently will have surgery this coming Friday because I’m having problems with the colostomy site eventhogh it was reversed. After the injection I had never had an abcesded tooth and I got one that needed to be extracted. I have lost 5 years of my life. All I can say is beware!
Wanda
2 weeks after my 1st (and last) prolia injection, 2 of my teeth became so loose and sore I couldn’t bite down. It’s been 1 month since my injection, my right hip, knee and left thumb joints are killing me, I have head aches all the time. My back hurts so bad I cry trying to get out of bed. I have been in bed this entire weekend due to pain and feel so bad. They told me to not have any dental work done for 3 months after my shot. That was my verbal warning. I will NEVER EVER get another 1 of these demonic shots. All the doctors office says is to take tylenol and alternate with aleve. I am allergic to tylenol and my stomach doctor says no aleve. No one warned me about all of this mess, or that it could kill me.
Kathy
My dr wanted me to start prolia TODAY! This afternoon a injection. Now I’m scared to death after researching this. It sounds like on this site and others I need to reconsider. What would you say to someone who is thinking of doing it? The insurance already paid for it and it’s waiting at the dr office. I laid awake all night thinking about this. And I have a shoulder replacement in 3 WEEKS scheduled. I could be in trouble even by then bc people are saying 2 weeks after Injection the pain starts and it’s poison basically. Why isn’t it banned already ? Greed? It was $1250 an injection!
Elizabeth
After stopping Prolia after two injections I have had eight spontaneous rebound vertebral fractures. I have been stuck in a recliner or bed for most of two years because of these fractures which have sequential. As soon as I would feel a little better I would have another one. No warning about this from Amgen or my doctor.
Barbara
After the 2nd shot I began loosing my voice. Diagnosed with paralyzed vocal cord, 10 months later a egg size cancerous mass was found in my neck. My Endo/ENT & Rheumatologist denied that Prolia was responsible. Coincidence…I think NOT!!!!
Rion
I have had 3 injections of prolia after #2 I was noticing some issues but had not made the connection just yet. I had some dental work done and I could barely open my mouth. What I thought was TMJ I now believe to be Osteonecrosis waiting for more testing. Ronnie please share more of your story since we seem to be experiencing the same thing.
George
I’ve had 3 shots of this drug in the past 2 years February is supposed to be my fourth shot. Left leg femur while walking just broke in half two weeks ago. Was rushed to the hospital and had surgery to install a metal rod in it. Surgeon said it was a Prolia related fracture. When prescribed to none of these side effects were mentioned to me. If I knew I would never have agreed to it
Gloria
I benn taking these shots for 2 years but no more for me I very afraid of them. I was not warned about all these bad side effects, severe weakness fatigue back pain leg pain nor was I told that my bones could break if I stop taking it. I was a very energetic 55-year-old that now feels like I’m 85-year-old no more shots for me
Ronnie
I received 3 injections of Prolia and developed osteonecrosis of the jaw. This is extremely rare. Do not want to go into detail as to what I’ve had to endure.
Jennifer
I had a very high reading for osteoporosis. In 2013 I was put on Prolia. I was given 2 injections a year. I worked very hard at walking and exercise classes. I was thrilled when in 2018 bone density scan showed I had become osteopina. My last injection was June 2018. In March/April 2019 a pain began in my low back. It moved into the whole of my back causing me excruciating spasms. I could hardly move. I admitted myself to hospital for pain relief. In July an MRI scan showed fractures in most of my vertabrae. I was shocked. In August I was told the reason for all the fractures was because I wasn’t taken off Prolia slowly
Sylvia
My life has.been ruined by this drug.have. had laminectomy Anand spinal fusion.was very healthy before taking Prolia.submitted report to FDA.with lot number of drugg.
Sylvia
My life has.been ruined by this drug.have. had laminectomy Anand spinal fusion.was very healthy before taking Prolia.submitted report to FDA.with lot number of drugg.
Sylvia
I took one shot of Prolia.my life has been.ruined.started with mouth ulcers.vaginal infections.then joint and muscle pain.then I got spinal stenosis.ennded up having laminectomy and spinal fusion.i was a registered nurse for 55 years.never had a backache.convinced it was all due to Prolia
Cathy
I had 3 prolia shots within 18months for a very small are on my hip of osteopenia.. .. After not being able to have Dental work done.because of 2 Dentists refusing to take care of me because of Prolia ..I went off the drug for 4 months ..I ended up having 2 spinal fractures and 2 more a few months later . This drug is poison
Roberta
How about death as a side effect? Yes, believe it or not, death is the number 1 of the top 10 reported side effects reported to the FDA for this crap! I will NOT be taking it!
Andrea
I had eight Prolia shots over a four-year period. My doctor decided to stop the injections. Eight months later (May, 2016) five of my vertebrae broke for no reason. I had to have surgery and lost a year of my life.
phulmatie
had one shot 3 months ago. I am a wreck back pain,gfr. went down to 45, cholesterol 278, ldl 182, tryglicerides , vldl. chol. 34. i suffer eye pressure eye doctor says this weird i have 2 appoints for lazer, unable to raise both shoulder at yoga class.itching and rash.was given naproxen .over counter for itching. i am scared. 73yrs.
Mary
I have flu like aches my teeth hurt my crowns hurt going to the dentist for it.My ear and jaw hurts. My labs are off the chart high livers high kidneys low My heart races but my teeth ache cold kills me with pain .
Glenda
I had 2 rounds of Prolia about 3 years ago. Second round put me in the hospital with pneumonia. Rash was on my cheeks, Dr. asked about it. I said I don’t know, it came up after the second injection. Since then I suffer from outbreaks of cellulitis! Wish I had never heard of this drug! I have constant back pain and constant outbreaks of cellulitis on my face!
Linda
I was on Boniva 5 yrs, then Prolia, needed a tooth pulled due to neglect from my dentist not taking care of a tooth the right way back in 2015, it needed a root canal and a crown,I even changed dentist in that group, she didn’t take care of the hole in the top of the tooth until my latest visit, she stated after the X-ray, wow, there is a big cavity. Duh the tooth had this hole for 4 years the tooth decayed to the point it needed to be pulled, couldn’t get it pulled due to a chance of necrosis of the bone from being on Prolia, they didn’t tell me I will never be able to get a tooth pulled. What happens, the remove the root, then file the tooth to the bone, the surgeon stated it was ashame that it wasn’t caught earlier, he could of done a root canal and a crown. I am so made over this whole issue, I am thinking of hiring a lawyer, but I don’t know if I have a case
PEGGY
I am at a loss to know what to do. I am 74 with osteoporosis in right femur. My doctor wants me to take Prolia. I have been reading the reviews and I am unsure about it. Is there anything else I could take for the osteoporosis, which the doctor said can get worse over time if I’m not on anything. Thanks.
Donna J
After taking a Prolia injection, I incurred a fracture of my Luna & radius. Since taking Prolia, I have suffered an enormous amount of bone issues. My cervical spine has dibilitating pain from herniated discs, thoracic vertebrae, 2 & 3 are a mess after a 2003 accident. My lumbar area as well as my cervical area are in constant pain, etiology unknown. My feet have now started hurting, my right foot with a pronounced amount of abnormal bone growth on top. Most likely a bone spur. Now, the bottom line – once I took Prolia, I have issues swallowing. I have had a barium swallow which showed abnormality of flow from my esophagus to my digestive system. At times, my throat completely closes – all I can do is control my breathing through my nose, spitting as I am unable to swallow. I have been prescribed hyoscomine, which helps when things become urgent.
Elizabeth
I’ve had 8 or more spontaneous vertebral fractures since stopping Prolia two years ago. These are REBOUND FRACTURES caused by stopping Prolia This has been well documented but I wasn’t informed of this risk before stopping the Prolia. I am now disabled from all of these fractures.
Teri
Severe joint pain, inflammation, muscle aches and snapping hip syndrome following one and only injection of Prolia. I also had 2 crowns fall off my teeth secondary to calcium /bone loss and bleeding gums.
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