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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
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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