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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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Last updated on May-15-12


READER COMMENTS

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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