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Prolia LInked to Serious Adverse Events in FDA Reporting System


Raleigh, NC: According to a study published at a medical meeting this week in North Carolina, more than 40 serious cutaneous adverse events linked to the osteoporosis formulation of Prolia (denosumab) were discovered in a review of FDA records. Nine of the people who suffered adverse events required hospitalization.

The adverse events, reported in the FDA Adverse Event Reporting Systems (AERS) include angioedema, cellulitis, and pustular dermatitis. Dr. Beatrice Nardone, MD, of Northwestern University in Chicago presented the data at the annual meeting of the Society for Investigative Dermatology. She noted that most of adverse events were limited to the denosumab formulation for post-menopausal osteoporosis osteoporosis, Prolia 60 mg every six months, and not the formulation used to treat, cancer-induced bone disease, which is higher at 120 mg every 4 weeks.

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Published on May-15-12


READER COMMENTS

Posted by
Patrick McClintock
on
I had one prolia shot eight months ago, I developed severe muscle cramps in my shoulders, hands, feet and tounge of all places, I became so fatiuged I could not walk across the room. To this day my feet hands and lips tingle, hurt and are numb. It is hard to imagine pain in the bones but my feet and hand bones have become very painful. I still have severe fatiuge. When will it end? My Dr. said by six months, but this has not been the case. Are there attorneys that can handle this sort of thing?

Posted by
Geri Farasopoulos
on
I have had 2 prolia shots. After the second shot on December 12, 2016 I suffered SEVERE hip pain almost immediately.
I was used to walking over 5 miles every day. I could hardly walk to the restroom. Within a couple of weeks I noticed massive amounts of hair loss.
Almost a year later, hip pain is better so I am back to daily walks often with the help of over the counter pain reliever.
What is left of my hair, is still falling out with no sign of regrowth. Since taking Prolia my cholesterol is now high. This drug has definately effected my quality of life.
I will never take Prolia again.
I am 62 years old and have always been fit and had excellent health.

Posted by
Connie Wiley
on
Heard a recent commercial with Blythe Danner, at then end I heard the words--side effect--voice problem. Well I don't know when exactly yet I started the Prolia. But I remember in Jan 2010 we went to Vanderbilt University to see a well known ent who treats the country music stars voices. After seeing a local ent and now going to one in Cinti for over a year for botox shot to the vocal chords. I was diagnosed with sphaspomic dysphonia--vocal chord tightening.
Now I know the cause Prolia. I have a terrible time talking to people especially on the phone. They think I'm sick, deathly sick. I'm not. At my recent wellness visit-my dr told me I rank in the top 1% of women my agel--69. No other problems. I'm well and help my husband on the farm. I live with this voice problem every time I talk.
.

Posted by
Janine Pieper
on
I developed vitiligo since having Prolia injections.

Posted by
Diane
on
Had my first (and only) injection in January. This has been the worst 10 months I have ever had. March had severe muscle pain back of left knee, could not walk up stairs. Had to ask for help at airport when I could not walk very well. Went to Physio, did not help. Also began to have severe pain and numbness in my hands and feet, especially at night. Then i developed a terrible rash on my lower legs and arms, could not scratch hard enough.
Dr. suggested a couple of ointments, then a prescription, nothing helped. Finally asked to get an appointment with Dermatologist. Another prescription which is helping but still skin is terrible. This is end of October and my shoulders, upper arms are so sore I have trouble sleeping. In Sept. had a prescription for anti-inflammatories for a terrible pain in my hip. Thought it might be a fracture, but it wasn't. Never again, thanks.

Posted by
Cheryl Stallings
on
I have been on Prolia for approximately 2.5 years and have been diagnosed with External Root Resorption on 6 teeth. There was no evidence of this six months ago. I am unable to have my teeth pulled as the bone in my mouth is too brittle which means that I am unable to get implants at this point. My only option right now is to have a root canal done on each tooth and then it's the waiting game. I have not had a shot since February and will not be getting any further shots. My last bone density test showed a slight improvement. ehealthme.com has an interesting report regarding women 60+ who have taken this drug. I have had six different dentists who have reviewed my X-rays and each of them has indicated that they have never seen anything like it. I am not on any other medication and only take a multi-vitamin and Calcium with D. I also had a fainting spell in January, two cracked ribs and bruised head, that was finally diagnosed as dehydration which is also a side effect. I too have notified FDA and Amgen the manufacturer. If anyone knows of a class action suit or lawyer who is taking this on, please post so those of us who are victims can get some help! Thanks and good luck to all.

Posted by
Benedetta Betty Peu-Duvallon
on
I have had my second shot and have a very scary pain in my thigh bone. I just had an mri for my back pain. After the first shot, I complained to my internist that I was bent over and felt I couldn't straighten up. This happened after the second shot as well, but passed. Now my hip and spine are too painful. I also broke out. A lot of the symptoms listed are mine as well. How long does this stay in my system? I will not be taking another shot and will inform the doctor who prescribed it.

Posted by
Mary J Davis
on
I have been getting Prolia injections 2x's a year for 3 years. I too, have been at a loss why I feel miserable with fatigue, pain, and flu like symptoms continually. Now that I know what has caused this misery, how do I rid myself of the Prolia medication? My last injection was May 2017.

Posted by
Jaci
on
I had one Prolia injection in Oct 1916. Two weeks later I developed pain and weakness in my back and legs. I am an extremely healthy Eighty year old woman. I do not take other medication except OTC vitamins,calcium and condrotin. I did not take further injections despite my physicians telling me my pain had no connection to the drug. The pain has concentrated in my right leg. I have had numerous tests for blood clots, and fracture but nothing was found to be causing the pain. I have pain in my legs at night when I am lying down. I go to the gym daily but can only manage 30 minutes on the rowing machine. I used to walk on the treadmill but my right leg feels like it wants to collapse. This is a seriously evil drug?

Posted by
Sherry Sabesan
on
I had a Prolia shot on March 21st 2017. Since then, I have had a root canal, 4 teeth pulled, bone graft and oral surgery to try and correct the problem, including an implant that had to be removed. The pain is horrible for the past 5 months and am now trying to recover from the oral surgery. My dentist has stated he is sure the problem is caused by the Prolia shot.

Thank You

Posted by
Lavettah Brewer
on
I took the Prolia Shot 2-19-2016. I went from a healthy woman who had just had a physical and the Doctor found nothing wrong with me , to a totally different person. I have had all the side affects you can have, now facing loosing all my bottom teeth, all the bone is almost gone want be able to wear bottom denture, Dentist afraid to pull the teeth , afraid the bone and gum want heal because of the Prolia Shot. Had two root cancels in less then 6 months, sores in my mouth lips, pain in Hips , Arms,legs,Shoulders, Blanche off to the point I could fall at any time.Fell once injured leg had to go to Wound Clinic 6 months or more.There r more side affects I suffered, But I will never take another Prolia Shot . The Side affects are still affecting my body.

Posted by
Hermine Bayer
on
I had my first Prolia injection 6 moths ago. My husband has had it for years and suggested it to me. My hair fell out. My muscles were in pain. My back pain increases significantly (always had a bit of discomfort) When I stopped after the first 6 months my withdrawal symptom resulted in severe foot pain, like planta faciitis for about 10 days long but my hair loss stopped IMMIDIATLY I will NEVER take another one. I take a low dosage Magnesium and rather take the risk of the unlikely event to break a bone.
This is from Australia.

Posted by
Melanie Housty
on
My husband Steve was getting the Prolia shot for his osteoporosis. He started having a lot of problems with his teeth and when he went to an oral surgeon he told him to stop getting the shots immediately. Bad part, he had had one just the week before. In January of this year (2017) he had a full mouth exray and you can see where the bone had deteriorated on one side and was starting to do the same on the other. Since then, my husband has passed away due to a heart attack, so I am warning people against getting the Prolia Shot.

Posted by
Murnai
on
I am now 77. Horrific side effects began after my second shot March 2015 inc severe debilitating bone pain throughout my entire body. Unable to walk or do simple personal tasks I was an invalid for over a year in constant pain. A walker didn't help as my arms would not work. After blacking out I was in the hospital. My new doc said there was 88% inflammation raging through my body and I was headed for a stroke or heart attack when she started me on a high dosage med program which I feel saved my life. It's been over 2 years since the onset of this Prolia nightmare. I am still under my doctor's care, continue taking meds, but am getting my life back. The Prolia may or may not still be in my system, however the damage it leaves behind is life changing.

Posted by
maria nenninger
on
i have had 3 shots and have had shoulder pain, back pain, and hair loss,

Posted by
linda shephard
on
My doctor suggested taking prolia when I was diagnosed with osteoporosis. I bought the drug and it had two sheets of side effects with it. I then looked up prolia and found all of your comments on this drug. Needless to say, I WILL NOT be taking this poisen!!! I can not believe those idiots even allowed this drug on the market!!

Posted by
J. Szabo
on
The side effects I am suffering from started with my first Prolia injection for osteoporosis in men which I did not recognize until my 5th injection on May 5, 2017

?> Loss of top four front teeth because they became loose
?>Loss of hair over the last two year s
?> Increased Cholesterol level

Since my last Prolia Shot on May 5, 2017 I started suffering these side effects within two days after the shot.

?> Unbearable pain in my right shoulder and arm
?> My cholesterol level went up since starting Prolia
?> I have constant back pain
?> I have the urge to urinate like six to ten times per day
?> Loss of appetite, I do not feel like eating
?> Loss of strength I cannot even pick up an empty cooler

I to wish to join any CLASS ACTION LAWSUIT – Prolia should be banned from the Marketplace

I tried Fosamax which caused me incredible pain so the doctor switched me to Prolia. My mistake.

Posted May 15, 2017

Posted by
Diana Connell
on
I have been getting Prolia shots for about 4 years. At Christmas time 2015 I started having trouble opening my mouth. My left jaw hurt so bad I couldn't get through a day without eating pain pills like crazy. I say an advertisement from an attorney's office saying if you've taken prolia and have jaw problems call them. I never called but when my next shot was due I asked my doctor. He said not to worry but he postponed my injection for a year. Last month was the end of that year so I called. Now he is going to wait 3 years. I had to get an appointment anyway because I was having terrible pain in my hips. He ordered an MRI and I just got the News that I have Avascular Necrosis and the femur bone in my right hip has collapsed and my left hip has damage also but has not collapsed yet. I see a surgeon next week. I looked on google and found an article that points this all back to prolia. It causes a decrease in blood going to the joints and the bone dies. Needless to say I am horrified. I went from an active life to struggling to get to the next room. I am the soul caregiver for my disabled son and now i'm facing maybe multiple surgeries. I just pray that the pain I am now feeling in my knees is just from my walking different as the article said it also effects the knees, shoulders, and ankles.

Posted by
Esther Septimus
on
September 30th of 2015 my husband was given 1 of 2 shots of Xgeva (Prolia) for bone deterioration due to prostate cancer.
My husband was told that the side effects were minimal mainly tiredness.
Less than 2 weeks later one side of his face became numb. I called the doctor's office the nurse told me that the doctor said not to worry his body was getting use to the medication. a few days later he was so week that he needed assistance getting out of bed.
Then no appetite. needed a walker to go to the bathroom. Called the doctor again I was told we have to give it time. He was scheduled to go back to the office for another shot Oct. 30th 2015
This time my son wheeled him in, in a wheel chair.
The Physicians Assistant ran out of the room and called the doctor, came back and said "No more shots" and took a series
of blood tests. That night I got an emergency call from the Assistant stating my husband had to go into the hospital because his potassium was extremely high, another blood test showed that his sodium was extremely high. I contacted my husbands primary care doctor we put him in a hospital thinking that once the potassium sodium levels were stabilized he would be O.K and we could contact an Orthopedic Oncologist. The length of time he was in the hospital was 21 days.
My husband passed away Dec.3rd 2015 Less than 8 weeks from the time he received the shot
Doing research later, we found out that in people that already have cancer Prolia produces at first, a Cancer flare. Yet the doctor told us that Xgeva (Prolia) was having success building bone in Cancer patients.
We believe my husband had more years left to his life and Xgeva (prolia) cut them short.

Posted by
Audrey Shapero
on
Had prolia shot in November 2016 and body aches began about two weeks later. They persist still. Cannot sleep because of pain. Started in lower extremities and now in arms and shoulders. Taking ibuprofen double dose every 6 hours. Will not be getting another shot!!! This horrible drug should be taken off the market!!

Posted by
Rob
on
Without going into great detail. I need to ask how does Prolia poison leave the body once the 6 months is over ? Thank you

Posted by
Becky Wimberly
on
My long list of side effects started approximately 2 months after receiving my 7th Prolia shot. I experienced extreme fatigue, fever, and could not sit comfortably for about 6 weeks. I could not lift my arms above my head and could barely dress myself. I was diagnosed with frozen shoulder. It has been almost 11 months since my last Prolia shot and the side effects I mentioned above are better. I still have pain in my hips, groin, and shoulders. I have trouble climbing stairs and I feel "stuck" after sitting even for a short amount of time. I cannot stoop down to pick something up due to the back of my legs being extremely tight. My husband and I have noticed a difference in my gait when I walk due to the hip pain and I've had to stop walking on my treadmill because walking aggravates my hips. I occasionally experience dizziness when I roll over at night. This last shot has pretty much stopped me in my tracks for almost a year now. It will definitely be my last Prolia shot.

Posted by
Jeanne
on
My mom had one injection 2/10/2017 and her life has been hell. My mom will cry and say all this because of a shot. My mom who has always been a fighter, made the comment that living is not worth it any more since this shot. Extreme pain to the ER ended up getting an injection in her back for the pain, plus an increase in her morphine. Increase pain in shoulders, and hips. Fevers on and off. Now fluid on her lungs. Muscle cramps. Extreme fatigue to where she can not get out of bed. Bladder issues, diarrhea, poor appetite,and the list goes on. The sad thing is it has been a month and symptoms keep adding to the list. PLEASE WARN OTHERS NOT TO TAKE

Posted by
Linda Deringer
on
I received two injections of Prolia in 2016. I have been extremely ill since then. I have experienced all of the mentioned symptoms in these blogs. I went through a series of CT scans and still have no answers. Doc says not related to Prolia. I wanted to ask him who gave him his injection. I am concerned the medical community is afraid of lawsuits so no agreement from them to date. The aches and pains never go away. I now have liver problems with no prior difficulties. Developed pancreatitis. I do not consume alcohol so go figure. This is extremely dangerous chemical injection. Take your chances with osteoporosis rather than this quick fix which does not exist. Walking, taking calcium vitamin D, sunshine, good diet is an easier and healthier way to go. Just call me "regretful"

Posted by
Jana M. Rhodes
on
I have had a series of 2 shots of Prolia. Third shot is due April 6, 2017. I will not be taking the 3rd shot. Within the past year I lost 2 teeth and another one is loose. I've lost hair and have peripheral neuropathy in my left foot. The way things are playing out I would rather have broken bones than be bald, toothless and limping.

Posted by
Peggy Hollis
on
I was given a prolia shot in my left arm 9 months ago after a bone scan showed osteopenia. Within a few weeks I had terrible pain in my hips and thighs. Then I began to have recurrent bladder pain feeling the constant need to urinate and pain in my back. There urine tests showed I have blood in my urine. And after 3 antiobiotics the infection is no better. I also began having deep pain in my left arm 2 months around my rotator cuff. I am seeing and orthopedic dr and physical therapist. The x ray and MRI show I now have a frozen shoulder and will be having manipulation surgery this month. I am convinced all of my painful disabling illness has been caused by the Prolia. I am devastated and so scared.

Posted by
Barbara Stone
on
I have been getting Prolia shots for about two years now. I have severe bone and joint pain. My right arm hurts so bad I can barely use it sometimes.My teeth ache all over, and I have a blister-like sore on my ear that will not go away. I will not take the shots anymore and I cant take the pills either. I don't know what to do.

Posted by
Winter
on
I had my second Prolia shot in March 2015 after which the side effects began. After almost 2 years of severe bone and muscle pain, and numerous other miseries too numerous to list, I can now walk somewhat normally and do most things for myself. The improvement is due to my good Rheumatologist who found that my body was inflamed and immediately started me on a regimen of meds that I believe literally saved my life. Before Prolia I was an active 75 year old that exercised and walked daily. Prolia put my life on HOLD, but I am thankful that I am heading toward total normality. Jan 2017

Posted by
Helga Collins
on
I had my second Prolia injection July 2016, a week later blood in my urine, which I've never ever had before. Massive UTIs continually for months. Antibiotics didn't seem to work. Ultra sounds on kidneys and bladder, a systcoscopy by a ulorologist. By September I had the worst chest infection, couldn't breath, doctor thought I was heading for pneumonia. The aches and pains in my hips, legs and arms are something I had never experiences before. I am about to head off to the doctor again for my newest symptoms, fever, chills, sore neck, arms and night sweats with extreme tiredness and no appetite, and that's just not me. Worst is the fact no one told me about side effects and since reading about it all and mentioning it to the doctor and urologist, they both think it's a coincidence. WTF.

Posted by
Dolores Matuska
on
I was very ill for nearly two years during which I had three Prolia shots. I have NEVER had a reaction to a medication before and never dreamed it was from the shot. Some meds have not worked for my osteoporosis so went to the next new one to try. I had my last shot in June 2015 and ended up in emergency on a trip two days later with swollen lips. Had at least a year of upper respiratory infections that did not respond to anything, terrible coughing that eventually caused a horse voice that still is there - not as bad as before, but if I get a cold or anything I can hardly be understood. Then I started getting weak and shakey, broke out in continuous hives all over, ended up in emergency several times, once one side of my tongue swelled up, eye swelled up, lip swelled. I was tested for allergies (negative), Lupus (negative), thyroid (negative), damage to throat (negative) to name a few. Could not keep my blood pressure under control so kept trying other meds, have had two teeth pulled and others filled. My husband and I were watching an ad for Prolia on TV and when they listed the possible side effects it fit mine to a T. I called my Dr. immediately and she said that was a real possibility so since I was due for another shot we cancelled it. I then asked to be taken off ALL the meds they had me on including Prednisone and just deal with the blood pressure and pulse problems. She set up a schedule of withdrawal and after each one if the hives didn't come back we proceeded to the next med. After a year + I have no recurrence of the hives (large water filled blisters) but still have periods of shakiness and itching, hoarse throat and tooth problems. I hope they take this drug off the market. Right now I am only taking Calcium/Vit.D, low dose aspirin and Losarten/HCTZ for my blood pressure.

Posted by
Suzanne Gault
on
I have taken three Prolia shots. Due for a 4th in December, 2016. I will not be taking it because of all the problems I have had since starting them. My doctor said none of those systems are from Prolia. I find it hard to believe that all of a sudden upon taking the shots, I developed severe symptoms that I never had before. Symptoms include, leg and foot cramps at night, aching all over especially legs and hip,extreme skin change, skin itching, 2 UTI infections that I haven't had in years, diarrhea, seems like blood with bowel movement, have had colonoscopy within year, no problem,can'the seem to excrete a good bowel movement, tired, low energy level. Totally all came on all of a sudden. Had a MRI on my back which shows some scoliosis. Doctor said back is in bad shape. I was going to therapy for sciatic pain down my leg. I due not have that anymore. None of the over the counter pain relievers help. Have gotten prescriptions from dOctober for arthritisale, which doctor said I have and they don't help either. In closing, I believe this all is due to the Prolia shot. I am going to doctor today because I can't sleep because of my aching body. I am 76 and always had excellent health.

Posted by
P hendricks
on
I do not know if Prolia is the cause of my problems or not. Within about 2 weeks after the 1st and 2nd, I noticed my skin was peeling on arms and legs. Nurse said absolutely not, she never heard of such a thing. (tho it IS listed as a side effect) And in the past year and half (had 2 shots, 3rd due in December) I am in constant pain in my left hip, groin down leg into ankle and foot on left side. First doc said it was sciatica (my thought too), then said no, it is sacroilliac (sp.?), now saying it is pinched nerve from L4 to6 surgery 2 years ago. Had three injections in spine and butt for the pain - relief for about 2 days. I am now unable to get out of the house much, now need a rollator even to get around in my tiny apartment (am 79 years old) am awakened during the night and am up for hours, by the pain, and am truly in agony ALL day. Couple of times I have talked one of my docs into a few Percocet or Tylenol with Codeine. So every now and then I have a couple of hours of 'normal'. I keep saying a little relief feels like I died and went to Heaven!!! It is brutally painful all day and night and I am going downhill for the past year. Now that I have read all the other comments, I am wondering if all my problem is from the Prolia.

Posted by
Gail Huston
on
My 80 year old mother with Rheumatoid Arthritis received a Prolia injection on May 19, 2016. Within two days she was suffering with what doctors thought was an upper respiratory infection or allergies. They put her on steroid inhalers and followed up two days later. Wheezing was just as bad and pain in chest had begun. Doctor took an x-ray ruled out pleurisy and gave her an antibiotic. Pain in chest moved into shoulders and within a six week period she was hospitalized twice and in the ER seven times. After the first week the Rheumatologist who suggested the Prolia injection felt she was having a reaction to the drug. All blood tests, x-rays, CT scans, and doctor visits have not been able to find a cause for the extreme pain in her bones with the most severe being in the hips. She went from an active senior to bed ridden using a bedside commode. She has gone from NORCO every 4 hours to Percoset. It still does not control the pain. Her blood work now indicates some type of bone marrow issue and she is having an MRI and bone marrow biopsy. The same test results were normal within 30 days prior to receiving the prolia injection as was her calcium and iron levels. Her blood protein which is regularly monitored has now more than tripled. Doctor performed tests for lymphoma and she is negative. Her doctor thinks it may be a spike due to the prolia shot and could just go back to levels prior to the shot over time. Although she suffers with the effects of high protein levels in her blood. Personally as her daughter I am tired of Doctors who keep asking me if she has fallen and that is why she has so much pain. I'm sick of Pharmacist who give me grief with her prescriptions because of the regulations and her need to increase due to pain levels escalating. I am tired of doctors who will give her a pain injection in the ER room after a 6 hour wait and send her home without any new treatments for her pain. I am sick of her GP who knows how much pain she is in and still insists she run out of medication because he needs to see her. Which then sends us back to the ER and the cycle continues. She just wants to die and cry's about why she ever took the shot. Every doctor doubts that all of this could be caused by the prolia shot but concur that it is the only possible reason after test after test comes back negative. Her Rheumatologist is "investigating" if there is a negative interaction between Embrel and Prolia. I would love to be included in any suit against this company and nobody should take this drug ever.

Posted by
Pattie Berry
on
In 2013 I received my only Prolia injection 1 year after being allergic to other bone strengthening drug. Within 1 hour of shot I had severe nausea and diarrhea. Within 3 hours, fever , chills, flu like symptoms lasting 3 weeks. Since 1 month of shot I have not been able to seep in a bed due to severe hip bone pain. Have slept in a recliner for 3 years. My jaw bones hurt constantly. Severe pain in feet, knees. I have to take calcium because my blood calcium levels fell severely low after shot.
I was 57 when I got shot and I have felt 120 since. I have had spots come on lungs since.
No one talked to me about side effects.
I beg you to think long and hard before ever taking Prolia.I would do anything if I could undo this. I can't enjoy my life , grandchildren since Prolia resulting in depression. My grandchildren were my life.
This should be investigated to see if proper testing and FDA laws were followed.
If I was offered a million dollars to take again, I would NOT!

Posted by
jane
on
My situation is pretty similar to Sue's posted 8/25/15. In early 2015 I was told that the results of my bone density test was very alarming & was referred to an endocrinologist. His tests confirmed the first diagnosis & suggested prolia. He said that there were very few side affects & never mentioned anything about possible major jaw problems. I researched the side affects of the drug before I agreed to the shot. At the time, the only side affects that were mentioned on their site was possible muscle pain, diarrhea, dizziness & a sore jaw bone. Since none of this seemed too serious, I agreed to the shot on 6/15/15. Within 2 weeks I woke up so dizzy that I was spinning which lasted for a couple of days after which I remained simply dizzy for a couple more weeks. On 10/18/15 I had diarrhea so bad for 2 1/2 weeks that I couldn't even leave the house. The worst side affect, however, is when my bottom right teeth were bothering me. My dentist said that I needed 2 root canals which we completed. The problem was that they didn't heal like all other procedures I've had done in the past. She finally asked me if I'd taken anything for bone density which of course I had. She was very concerned & referred me to a DMD who said I had osteonecrosis which has no cure. In the end, I will lose my bottom teeth & possibly need surgery for my jaw. More stringent warnings are now included in this drugs' warnings but they weren't when I originally researched them. I reported these side affects to the FDA & personally think it should be taken off the market & is worthy of a lawsuit.

Posted by
Michelle
on
I had a Prolia injection in 2014. It was the worst drug I have ever taken. I was sick in bed for a year and a half and still do not feel myself. I couldn't breathe, pain in back, legs and arms was terrible. Hospitalized 3 times, emergency room 3 different times, sooo many doctors visits, lung biopsy and every test imaginable...couldn't find the problem. I know the problem...PROLIA!!! It all started within hours of this injection. I wish I had time now to tell all of you everything that went wrong but I don't. I wouldn't recommend this drug to anyone. I have notified the FDA and made a monthly call to the AMGEN CO. with no help from either. I can't get anyone to help me.

Posted by
Wanda Binkley
on
I posted on April 26, 2016 regarding my reaction to the Prolia injection. Since that post, I have had to get another steroid shot the end of March and again on April 27th along with an antibiotic to try and clear up the rash on my legs which I still have as of today. I would definitely like to be included in a class action suit against the manufacturers of Prolia.

Posted by
ANN
on
Took Prolia injection 4 weeks ago. Worse overall pain in my entire body. Anyone considering taking this "poisonous drug" be better off in taking a real poison if you want to ruin the rest of your life. PLEASE BE EXTREMELY CAREFUL, AS PROLIA MIGHT ACTUALLY KILL YOU OR AT LEAST PERMANENTLY DISABLE YOU. If anyone is considering a class action lawsuit, please include me

Posted by
Brenna Zupan
on
Got Prolia shot Jan.20 2016. Within 6 hrs. had awful pain in my hips,lower back and neck. Have lost tons of hair, sores all over my legs,arms and ulcers on my tongue so bad I couldn't eat. Have numb toes and dizziness every time I stand and blurred vision.It's almost 6 months now and side effects are not getting better. Prolia should be taken off the market! Pure poison.

Posted by
J Mitchell
on
I had my first & no doubt, last Prolia injection 4 wks ago.
No immediate teaction but within about 5 hrs that night, pain started in my toes and fingers. It was excrutiating to walk. By the next day, I was in pain in my bones and joints and didn't want to walk at all; huge ordeal to get to restroom. Pain continued down shins, nausea and vomiting, severe GI distress for 3 wks with severe GI issues; even my voice has changed.
Pain has started to decline over past 2-3 days.
I have broken a total of 5 bones, my shoulder was a catastrophic break, healed wrong and left me with limited range of motion. Due to thin bone density, my ortho surgeon wouldnt consider rebreakung and resetting after 6 months of physical therapy.
Many years ago, I had Actonel prescribed & of course, it tapped out. Still after all of this hell, I doubt I will take the second injection in November. I am an RN, have Systemic Lupus & take steroids which thinned my bones. I dont know how this drug made it out of trials. Poisonous indeed.

Posted by
Denise Steele
on
Have posted earlier but am still having problems since FIRST AND LAST Prolia shot in September 2014.

My toes are numb, my hair is falling out by the brush load, have itch, depression, balance problems, and most concerningly problems with my kidneys.

Initially diagnosed with UTI which anti-biotics fixed, but now UTI symptoms that show no infection. Pain in my flanks and lower back and am having more blood work, ultrasound of kidneys and CT scan on my stomach. Also standard X-Ray of my back. I await the test results.

My doctor/s still say not Prolia related, and I understand that correlation does not prove cause, but I have had a cascading set of horrible symptoms that occurred DIRECTLY FOLLOWING my first shot, so am definitely not convinced that Prolia is not the cause.

I was a happy and active older woman until receiving the poison Prolia and can hardly drag myself out of bed.

I warn all people I know about considering EVER taking this drug. It has really messed with my life.

My love and best wishes to all who are going through this nightmare.

Posted by
Dianne Mackay
on
I get severe breathing problems since starting prolia January 2015. All heart and stress tests are negative. Does anyone else have these symptoms?

Posted by
Wanda Binkley
on
I received my Prolia shot on January 8, 2016 after much discussion about the side effects. Was assured it was totally fine. On January 14, 2016, I started having chest pains and couldn't swallow. Had burning when I urinated. Went to Urgent Care on January 16, 2016 for urine test to see if I had UTI. Came back negative. Broke out in a rash on my legs. Called doctor on January 19, 2016 to get a steroid pack because my eyes were swollen shut. Started throwing up the steroids. Stayed home from work on January 20, 2016 and slept all day. Had no energy and slept for the next four days. Lost 7 lbs. Went to work on January 26th and got really dizzy. Tried to drive home. Pulled off interstate. Passed out after I got home and had to be taken to ER by ambulance. Blood pressure got up to 203/106. Stayed in ER for 3 hours. Went to my doctor January 27th who changed my blood pressure medicine to stronger dosage and then it had to be doubled. Stayed home from work for the next week. Had to go for another steroid shot on February 27th because I broke out in another rash and my eyes were swollen shut. March 29th, blood pressure spiked to 180/100. Had to take another bp medicine to get it to come down. Stayed home from work on March 30th. Legs continued to stay broken out in firey red rash. Using Topical Antibiotic Solution prescribed by my Dermatologist. Told my doctor that I would never take another Prolia shot and not sure if my rash will ever go away on my legs. Have told everyone I know to not take the shot.

Posted by
barbara fallick
on
I thoroughly read all the literature on the side effect of Prolia. I asked five doctors about the side effect of Prolia. All of them reasured me that in their experience the side effects were minimal. I received the Prolia Injection on July 26th 2016. Immediately I became dizzy and had to be assisted out of the room. My friend assisted me home. The next day I suffered a pain in my chest and was advised to go to the emergency room as I was having a hard attack.. I was assured that there was nothing wrong with my heart. I fainted and given all the tests, cardiolology, neurology, and middle ear exam. By now, I was dizzy all the time, could not walk a straight line, unable to stand without being dizzy. and verdugo sympthoms.
I was informed I would never recover and the Prolia shot effect my electrolytes.

This has continued, despite physical therapy. I have to live in an assisted living home as I can not live alone because I am a fall risk.

Posted by
Judy A.
on
I had 3 injections over the course of 18 months. After the 2nd one, I'd wanted to stop because of the INTENSE pain in my femurs, hips and lower back. The bone density report had improved so much, the dr. talked me into the 3d injection. I was in unrelenting pain, and I do not think it was a coincidence that there was suddenly a sharp spike in my cholestoral levels. Now, come to find out, the "calcium" scoring test shows me off the chart of good health, and a lumbar X-ray shows a vascular calcification. I so regret having done this therapy and feel it should be removed.

Posted by
Lynne Jones
on
I had the Prolia shot Nov. 12. Around Nov. 16, I began to get
sores in my mouth, my tongue began to began to get numb &
the tip of the tongue had small cuts in it. Then I developed an extremely dry mouth. My dentist said I was developing no
saliva.
Dec. 16 I had a UTI and went through 5 doses of antibiotics.
I was in severe pain in my right lower abdomen and lower right side of back from that date until present. The end of Feb. my
doctor sent me to a gyro urologist because blood was in the
my urine 3 times. The new doctor said I had interstitial cystitis,
but my CT was clear, my cystoscope was clear, and after 5
bladder installations, I was no better. On day of 6 th visit, I told them that. I had run a fever all weekend and the pain was mire
intense. They said I had a UTI! Gave me a antibiotic, but after
a week, they called to say according to the culture, I needed
to take another antibiotic! I went to see my family doctor
who believes. somehow I gave a very resistent UTI. And, after
reading about Prolia said that could very well be the case. This has been a nightmare!!

Posted by
Anne
on
I had a Prolia injection August of 2015. The next morning I woke up with a mouth full of ulcers on my tongue, roof of mouth, & gum line. I immediately went to an oral surgeon. As soon as possible he did several biopsies & the results came back as a bacterial infection.(Immune system) Which is a prolia side effect. Within the next 3 days my hips, groin, I thighs were in horrible pain. I had muscle spasms that kept me awake @ night & still does to this day. In a couple of weeks my hair started falling out. All of the above are side effects of prolia. I am now past 7 months & continue to have all of the original effects of poison prolia. Needless to say I have made many visits to the Dr. to get something for pain. These was senseless trips. As I was in absolutely " NO pain" prior to the shot. On the Nat. Cancer Institutes site, it states that prolia is a cancer drug used to treat prostate & breast cancer. I do not have cancer & am very angry over being given this drug for osteoporosis. I have contacted the FDA twice & the Mnfr. Amgen .(Maker of prolia) My next venture is to contact both of my insurance companies & ask that they discontinue approval of this drug for treatment of osteoporosis & save thousands
of women from all the needless pain & suffering this poison
has created.

Posted by
JoAnn
on
I had my fist Prolia shot June 2015, I had a hard time deciding if I should take the shot so I spoke with the nurse in length before she gave me the shot and she told me that she had been giving the Prolia shot since it came out and had never had a reaction complaint from any of the patients so I took the shot. here are a list of the reactions I had and reported to my Dr. he took me off Prolia and ran blood test that he said came back normal but he even told me not to take any kind of supplements.
Pain in extremities, bone pain, rash in hair back of head, loose front bottom teeth that will probably fall out, vertigo, double vision that lasted about three weeks, anger issues almost violent at times, and now I have a very small cluster in my breast that showed up on an ultrasound that I have to wait six months to see if it grows or calcifies I was told not to worry that it doesn't look like anything serious but I am worried because I just read that new malignancies related to the breast have been reported while on Prolia.

Posted by
Denise Steele
on
Received Prolia shot September 2014. Crushing rib pain, hair loss, bruising, rash, bladder infection and now symptoms that mirror bladder infection but tests show no infection. Unusual bleeding in that I had a blood test and when syringe was removed blood flowed from the site. I have had many blood tests in the past and have never had this occur. I hate this drug and would not recommend it to anyone. I'm still suffering the bladder problems.

Posted by
Jane Ogden
on
After a Prolia injection in late October 2015, my hair started falling out. I've had only minor pain issues but now feel horribly depressed due to the hair issue. But then I see depression is also a possible side effect. I am sorry I did not do my own research on this drug before agreeing to receive it. I will not get another shot. Ever!

Posted by
Debbie Williams-Palmentera
on
I took my first and only shot of Prolia in June, 2015. Almost immediately my leg up in groin area started hurting. I went to Orthopedic Doctor. He asked if I had been in accident or anything. I of course told him no, but I had taken a shot for Osteoperosis on the almost instance of another doctor. The medicine was Prolia, and he said "oh you shouldn't have taken that"! He told me about the unusual thigh bone fractures and told me that he (and the industry) have already been seeing this bad side effect! He did xrays, etc and said there was activity on the bone. Put me on a walked and told me to see him in a month unless the pain was worse. Well, it did get worse so I went back. More xrays, etc, then finally on one visit he said he needed an MRIl. So I went and had one, a few days later he called me to tell me that it was fractured and that I need surgery ! Has anyone had this surgery?

Posted by
Mary Gleason
on
I had my first and only shot of Prolia in late August 2015. About 5 days later my face turned fire red and eyes swollen shut. Then my right hip which was replaced in May and was healed started butting when I walked. Then I started with serious diarrhea and weight loss. I am now on medication for depression and do not want to get out of bed. I've been to my doctor and he prescribed a topical ointment for the skin on mr face legs and arms. I called the people at Prolia and after telling this man all of my problems he said "How do you know Prolia was the cause". My Doctor has filed a complaint with the FDA. How long does this last and is there an antidote?

Posted by
Linda Taylor
on
My mother received Prolia shot on Sept 23 2015. A few days later woke up with tightening of the throat, tongue and face swelling. Was called by a dr to go to the nearest trauma center due to a decrease in kidney function and liver at crisis state. She had CT Scan due to complaints of a tight band feeling around back of head and a cardio gram and passed those. Went home and was called by another dr to come in for blood work. A nurse then called and told my mother she should have never gotten that shot. The blood work came back as hemoglobin down to 7, kidney function dropping and liver crisis state. She was admitted into hosp and was started on a gamet of testing. On day 2 lungs started to fill with fluid, IV shut off and given IV lasix. Over the course of her 8 day hosp visit was given 2 units of iron still the tests came back with no diagnosis. Having consulted with drs on a daily basis suggesting Prolia may be the culpret they turned a blind eye. My mother now resting with no diagnosis but was told at her follow up appt she was to never get that shot again. I have gotten on the Prolia website and did my own research and have have found she has multiple side effects like those associated with Prolia.

Posted by
LaQuita Smart
on
I had the Prolia injection in June of this year into my right arm. Few days later my arm and shoulder hurt so bad it made me sick to my stomach. I called the doctor that gave it and she said oh it will go away take some advil and other patents complained of this. Never went away as of today. I went last week and had a MRI. Results I now have what is called Frozen Shoulder. This is a result of the Prolia Injection. I am so upset over the fact that the Doctor that gave me the injection said little to no side affects. She also stated that Prolia is not what has caused my issues to my shoulder and arm.

Posted by
Sue
on
The comment by Janet is the first I have read that seems to pertain somewhat to my situation. In May of 2014 I received a Prolia injection. At that point I had no other physical problems but Osteoporosis. Six weeks later I saw my dentist for what I thought was a toothache. She suspected I had osteonecrosis of my lower jaw and referred me to an oral surgeon. I also had a root canal above the dead bone area that I now think was probably unnecessary. Since then I have had monthly visits with the oral surgeon as he observes the affected area. My most recent visit after a six month period showed that the size of the dead bone had increased. So my oral surgeon visits will return to every 3 months. There is no fix for it. Surgery would only make it worse. I am in a holding pattern and am just waiting for the dead bone to release and fall out, as I was told would probably happen, and hoping that it does not again increase in size. I came to this site to search for others with osteonecrosis that had not had cancer treatments but had received Prolia injections.

Posted by
Janet
on
I had an injection of Prolia and 2 months later I started a dental implant in the lower left jaw. I also had an implant in the lower right that became loose. After the surgery I began to have severe pain in both jaw and was on narcotic pain meds for about 6 weeks. Almost a year later I still have discomfort, have significant bone loss, and the surgeon (not the original, who is no longer with the practice) is being very cautious about doing anything but waiting and examining the sites every 3 months. I did inform the original surgeon that I had taken the Prolia injection but he seemed unconcerned. The new surgeon seemed unfamiar with Prolia but is well aware now.

Posted by
Pauline Rohloff
on
Received my Prolia shot in Oct/Nov 2014. I immediately started to have pain in my hip and groin area. Thought it would go away, took pain meds and still had pain. Rec'd shots in my back, still no relief. Finally tried a chiropractor and was informed that what I have is one of the side affects from the drug. Is there anything that I can take to help this problem. Thank you

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