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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
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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