Prolia Side Effects (Page 112)
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I would like to know of any side effects others may have experienced after receiving Prolia infusions. Up to now I have none.

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Anne~I was on 90 mg mirtazapine (an anti-depressant that causes sleep), 60 mg of Remeron, 40 mg valium, 24 mg of tizanidine. The last 3 were divided out between when I went to bed and the next dose - when I woke up in the middle of the night. It seems with Prolia they only lasted 3-4 hours without taking them again. I was not allowed more mirtazapine as 90mg is already maxed out. I absolutely refuse to take Xanax. it's difficult to quit. I am not having to remed in the night so it has been cut in half but I'll probably have to wait a couple of more months to end most of them and I know he will have me do it very, very S-L-O-W-L-Y. I am still sleeping really well. Tizanadine is really nice too if you want a little nap in the afternoon for a couple of hours. One 4mg tablet = a very nice nap. That I will have to keep until I get my back done -- it's a muscle relaxant and I'm allowed one in the day time if my back starts acting up. It's a weird combination, but Psychiatrists do whatever works and they will tinker with it until they get perfection. I asked to try the new Belsoma or whatever it's name is. I got 1 hour sleep and the bottle was returned to him the very next day. Hope this helps~Pood

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Kitty - use whatever 'search engine' you usually use, be it Google, Yahoo, or whatever and key in "Amgen Corporation". You will land on their home page. They make lots of different biologics so you have to search thru their products to find Prolia. Click on it. Then all of their information on Prolia becomes available to you from the clinical study, to packaging info, how the inj. should be given and a Dear Patient Letter that apparently our MDs do not bother to use. There are other websites with more information on side effects; put in Prolia and they list far more side effects than Amgen admits to. The info I give to people here is straight from Amgen. I only use others for backup purposes.

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F~I have never heard of anyone yet to have kidney/kidney dialysis or liver problems from Prolia. If a previous kidney/kidney dialysis problem were known, the Dr. should not have given her Prolia. It is contraindicated. Heart problems - yes, immune problems - YES, bladder infection - YES. There is a group of ladies in Australia that have their own forum on Prolia but I don't remember what it was. They are as unhappy as we in North America are with it. You can go to Amgen.com and copy the label that comes in the packaging, also they have the 'Dear Patient' Letter that none of us got and they list most of the side effects. We know there are more but they are not listing them yet. If I were you, I would call Amgen on the phone (it's listed on their website) and ask them straight out about the kidney because there has to be some kind of a relationship between Prolia and the kidneys or they would not want people with kidney problems to take it. Perhaps that is one pathway by which Prolia leaves the human body?? MD's don't seem to know the answer to this question and I'm not sure that Amgen does either.

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Hi Kitty! I hope I can help you find the labeling changes. Go to FDA.gov then click on the "Drugs" tab along the top where all the tabs are then on the right hand side under spotlight click on "search drugs @ FDA" (the second item). This will take you to a new page and in the search box type in Prolia and push submit. This will take you to another page, it should say "drug details", scroll down just a bit and click on label if that's what you would like to see. Then scroll down and you will be able to see all the dates of label changes. Click on the word "Label" in the box over towards the right hand side on the date you would like to see (dates are on the left hand side of the chart). You will then have to scroll down to page 2 of the label information and on the left column you will see "Recent Major Changes". This is where it lists what was changed on that particular date. I hope this helps. If not, please let me know, I'll try to help more. On the "drug detail" page (if you choose to go back there) you can also click on Letters, REMS, etc and see other information as well. Prolia and Xgeva are listed together as they are both considered denosumab. Good luck. You can call FDA and get to one of their pharmacists also if you ever have questions. I've actually had pretty good luck in speaking with them.

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What type of "cocktail" did your psych. give you?? I am in the US, not Canada, but can have access to Canadian names of meds translated to US meds.

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Where can I find the Prolia labeling changes? Please be specific as to where they can be found.

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poodle, does the Insomnia ever go away? I used to sleep 7-8 hrs. every night with no interruptions and now am on Restoril max. dose (a benzo) and get 5-6 hrs. at times and others 7-8, but all interrupted and I hen have to take a Xanax. I was never a pill taker in my life. I am 76 yrs. old, but very active and only retired at 75. Now, all of a sudden, I got IBS-D according to my doctor and believe me, that diet is like eating cardboard and I sure miss my morning cup of coffee!!

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I would like to know how long it will take for the body to get rid of Prolia. My siter is 83 years old, had 1st Prolia and hd mild side effects,2nd Prolia she said never felt this worse in her life....she had to be ospitalized, 3 weeks and tests came all good, doctors said it is strss! My sister doesn't know what to do anymore, one day she fees better other days her blood pressure goes up, she has to stay in bed feels dizz confuse agitations rapid heart beat.Doctor doesn't explain why she feels this way.she lives in Australia,she askes me if I could find out if the body will get rid of this awful medicine! She is afraid the medicine hurts the liver and kidney! Are other with the same simptoms? Please help my sister Thank you Fiorina.

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I just want to take a minute to thank every person who might still be on this site from time to time for contacting the FDA or Amgen and reporting your concerns, complaints, side effects, etc. The FDA has required many changes in the labeling and literature in this nasty drug Prolia during 2015. Almost monthly changes so I think we're getting through to them just a little bit. Please keep contacting them. I would love to see this drug pulled off the market. I have yet to see ANYONE who had had help with their bones from this drug if that's the reason they were put on Prolia! You can correct me if you know of anyone. And I know some people said Amgen is now telling them it will take 10 years! I'm not sure how Amgen knows that unless their evaluations started over 10 years ago (and I don't know how we know that) because Prolia has only been on the market for about 5 years! I'm working to get it to be mandatory that health care providers must check their patient weekly for side effects when being put on this awful drug of Prolia. It is sooo important to have blood calcium levels closely monitored while being on this drug which my dad's were NEVER checked by his prescribing doctor when my mom would take him for appts. It only got checked by a doctor in the hospital months after being on Prolia and only because I insisted. At that point they were about ready to put dad on life support as he couldn't breath, they thought he was having a heart attack, and many other issues. His labs came back showing very low blood calcium levels so they started IVs to correct it and within 2 hours he began to improve. His calcium levels were never checked again after that and he continued to go downhill with the same issues plus additional side effects. So very sad. My dad was miserable from day #2 of being on Prolia. Just please keep contacting the FDA and Amgen. You are appreciated more than you know! If this drug was helping people it would be a different story but I see it doing more harm than good.

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Ann~ insomnia is a common side effect. Most people get it while on Prolia. I had a nightly cocktail from a psychiatrist that kept me sound asleep. Amgen states that one can have constipation, I believe. I would suggest another blood test for your immunoglobins to make sure it didn't give you Celiac Disease. It did me and I had your symptoms. I really could not believe the results of the blood test when it was sent to me. It would be iga that would be low. It's a simple blood test. For some strange reason, it seems like Prolia loves to cause autoimmune diseases which then disappear when it disappears. There are now 3 confirmed Sjogrens and my Celiac Disease. That's what happens when they tamper with our immune system and Prolia really tampers with it a lot. Not only are we prone to infections, it causes our own bodies to turn on us. Cannot say I loved the food but it was better than the problem. Be well~

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My recent Calcium level is 2.29. I think it is equiv. to 9.17. the doctor said it is ok, but I am not sure is it a good level for a Prolia victim or not?

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Poodle - I didn't stop taking calcium and vitamin D, now my calcium has magnesium in it. If I felt crampy, I took extra magnesium also. Even when I had told the doctor that magnesium also help to stop muscle cramp (especially needed for Prolia), they just didn't believe in it, they all said it only help to stop constipation. My goodness.

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Poodle: I am sorry you had to endure so many side effects. With that being said, because of your experience you have helped many on this site.

Just a comment on the ten year study. Type in "New data show consistent safety profile up to ten years". It is dated 10/12/15. The article reports on the "safety" of Prolia over a 10yr. period.

I didn't have time to read the article. Amgen told me originally, Prolia was tested on 7,800 people. Half were given Prolia the other half non active ingredients in Prolia. If I remember correctly this study was done for three yrs. Maybe they continued the test on the same people up to 10 yrs? I don't think we (general public) are part of the 10 yr. study.

As for sending mice/rats into space, I know that weightlessness does increase bone loss. Maybe that is why they send them into orbit?

I also want to encourage patients with adverse effects to contact the FDA.

Wishing all a HEALTHY New Year!

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I HAVE THE OPPOSITE, ibs-dIARRHEA and my far bigger problem is Insomnia which began shortly after my first Prolia shot. Does anyone have any of these problems - one or the other or both?

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It reads like yours was like mine. In the 5th month I got better and at the 6th close to 100% well. My hair still falls out some and I will need more dry needling after I can get out of the house but those are my only complaints now when I had just about everything Prolia had to offer and some they never heard of before. At least I can have real food again and that in itself is a blessing. Yes everyone - Prolia has a twin called Xgeva. Xgeva is for bone cancer. It just contains more of the active ingredient than our Prolia does. My Dr. pretty much uses biologics and she said that Prolia is only a number one compared to the rest of them. She also works in concert with an Immunologist for those patients. If this is only a 1, I'd die for sure with a 5, let alone a 10. I don't believe I have stated on this thread that Prolia is made from the ovaries of Chinese Hamsters. Amgen also sent mice into outer space to find out the effects of that with them on Prolia. I fail to understand the WHY! Also, a man named Mike at Amgen told me they are doing a 10 year study of Prolia. I wonder, really wonder, are we the ones in that study. This is why I encourage everyone to report every side effect from Prolia to Amgen and the FDA (or whatever Canada has too). Have them written out so you don't forget anything. Call every time a new one comes up. Call and keep calling. It will take a lot of effort on our part to get this off the market and it is now everywhere in the world. I know for sure people in Australia are complaining a lot. They have their own Forum that I wandered into one day. And, most importantly, reject the second inj. I had a broken back with 4 breaks in my hips. That was zero compared to Prolia. Had to remain in bed for 6 weeks. Big deal. I specifically talked to my surgeon for my hip replacement about having osteoporosis. He replied: No problem. We will just use lots more glue. Also found my last bone scan when I was on Calcitonin-Salmon. It did have improvement, just not huge improvement so I'm going back on it. Perhaps slow and steady wins the race. I know for a fact it saved my Mother. She took it until she died of old age at 96. No more broken bones even when she fell. Maybe this will give some more info that seems to be lacking on Prolia. Call Amgen and ask them to send you the packing info for the Drs and us. Then you will know for sure it's Prolia and also ask them to send you the "Dear Patient' Letter" that we never get. We are being let down by our own MDs. How many here had a pre-Prolia blood test and dental clearance??? Make them stand accountable and demand help. I had caught a diarrhea bug that was going around. After I didn't get well in 3 days my GP decided to send me to specialists -- never taking into account that my immune system was hardly working. Finally it killed the bug before I had the appointment with the specialists. This is what we have now called a MD. Thank Goodness for this place where we can freely discuss what's going on with us. And, Canadian, I was on 500mg Magnesium when I felt crampy…not every day, just when a big muscle cramp would come and hit me like a thunderbolt. Hopefully you can start your calcium and vitamin D soon. I fail to understand the reason for taking you off of it when Amgen states we have to have it. If Prolia does not get the calcium it wants, it will rob it from a muscle and that is the reason for the cramps. The human body is unable to store calcium in any other way. You may need to explain basic biology to your Doctor. Be well all and have a healthy New Year~

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It has been 4 months, 2 weeks, & 3 days now since I had the POISON PROLIA injection. I woke up this AM feeling less pain than I have had in the last few months. I pray that all of the sleepless nights in pain are going behind me now. The constipation is horrible & hope it soon leaves. My hair is falling out & am now on prednisone to help stop it. My Dr. said I now have dermatitis on my forehead from this awful shot. Prolia is a cancer drug (Which I wasn't informed of) What is Amgen trying to do - kill the cancer patients! Go to FDA.gov & look up cancer drugs. There you will find all of the info you need to be better informed about this nasty drug. Funny the Amgen website doesn't reveal this information. Shame on them & the FDA for for approving this life threatening drug.

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The effects of Prolia, fat around waist and constipation, linger long after 6 months of no drug.

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After 20 months I can say I am totally back to normal Thank God !

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Good for you Carolyn. Hope it all leaves and you can live in peace. Keep getting better~Pood

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Gayle, keep us posted on your test. Would love to know the outcome.

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