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Prolia: Another wonder drug that wasn't

Prolia: Another wonder drug that wasn't

Picture of Martha Rosenberg

Monkeys developed tooth and jaw abscesses and two died of protozoal infections. Human subjects developed cervical, ovarian, pancreatic, gastric and thyroid cancers and breast cancer was the "most common adverse event that led to discontinuation" in trials. Adverse event?

Ten people were hospitalized with the skin infection cellulitis during trials and one died. 

But the FDA approved Amgen's Prolia (denosumab) in 2010 to prevent fractures in women with osteoporosis, two months earlier than expected. Why?

Anticipating Prolia's approval, Thousand Oaks, CA-based Amgen deployed 1,000 reps across its "bone health, inflammation and hospital teams" to call on a "large number of physicians including specialists and primary care physicians who treat postmenopausal osteoporosis," reported Medical Marketing & Media. Follow the tote bags.

No one seemed to notice that the FDA clinical reviewer Adrienne Rothstein, MD had stated that Prolia denosumab "has the potential to affect multiple layers of the immune system" before its approval and that "three subjects required hospitalization for pneumonia after a single dose.” This is a great new “treatment option”?

The bone drug market opened up for the drug industry 12 years ago when the hormone replacement drugs women were taking to prevent fractures were found to increase their risks of cancer and heart disease. Bisphosphonates like Fosamax and Boniva (the latter, advertised by actress Sally Field) were quickly substituted as a way for women to keep their bones strong and stay young looking. But soon they revealed risks of their own. In addition to intractable pain, atrial fibrillation and causing (not preventing) atypical fractures, bisphosphonates were linked to jaw bone death (osteonecrosis) and esophageal cancer.

Soon Prolia began to appear no safer than the bisophosphonates though it belonged to a different class of drugs. A monoclonal antibody derived from genetically engineered Chinese hamster ovary cells, Prolia carries warnings like other “MoAbs” about opportunistic infections, anaphylaxis and worse.

Two years after its approval, Amgen issued warnings that Prolia could cause serious risks like "hypocalcemia, serious infections, suppression of bone turnover, including osteonecrosis of the jaw” as well as “atypical femoral fracture” and “dermatologic adverse events."  Notably, these are the same risks bisphosphonates bone drugs pose. Six months ago the International Journal of Clinical and Experimental Medicine also reported osteonecrosis of the jaw with Prolia.

Everyone has heard of "mission creep." In the pharmaceutical world, “approval” creep means getting the FDA to approve a drug for one thing and pushing a lot of other drug approvals through on the coattails of the first one.

But there is another, more insidious creep seen with drugs like Prolia- "warning creep": acknowledging new and alarming warnings after a drug is approved and in wide use.

Like so many expensive drugs aggressively marketed today--Prolia cost roughly $1650 a year—a risky drug made billions despite its risks, which were clear when it was first approved. Prolia “provided Amgen with $884 million in US sales between 2011 and 2013 and $1.4 billion worldwide for this same stretch,” reported Medical Marketing & Media. 

Critics of the drug industry have often accused drug makers of building injury settlements into their business and marketing plans in blatant disregard for patient health. A drug like Prolia suggests they are right.

Comments

Picture of <span class="username">Guest (not verified)</span>

Warning creep is exactly right. I have been writing and calling the FDA and Amgen trying to get them to put out new literature, change their magazine ads, change television ads and all info about Prolia to include that the side effects MAY continue for more than 6 months when getting an infusion. The drug reps for Amgen and the doctors are misleading people and "talking" them into getting the lethal drug by making the patient believe that the drug and side effects are out of the body in 6 months. This is an outright Lie and it needs to be stopped. I was told by a pharmacist at FDA that the drug will be out of the body but the side effects may continue. How do we get this information changed that is given to people who are considering this drug and how do we get doctors to make this very plain to people that the side effects might linger for several months? Please go to Medschat, read thru many of the comments about Prolia and see how many people can't figure out why their still so sick long after 6 months. You will see that many of them assume they should feel no more effects of the drug after the 6 month "day". The drug companies make me sick. All they care about is making money and not about human health! It's getting ridiculous. The doctors have got to STOP loading people up with drugs. My dad just died. Got a Prolia shot, got sick within a day, fell the next day and now died. He was on almost 20 different pills a day! Is it any wonder he was sick? and then top those off with Prolia? He could barely walk before Prolia and then add that gruesome drug and it was all over. Please help me. I want Amgen and the FDA to be forced into changing the information about Prolia and so far both are ignoring me. Please help.

Picture of <span class="username">Guest (not verified)</span>

I am so sorry for your loss. I agree with you 100 percent. I had the injection in June 2015. My life has never been the same. The injection was into my right arm and within days my arm ached so bad. It is now where I am miserable. I had a MRI done and now I have adhesive capsulitis also another name as frozen shoulder. My arm and shoulder was fine until then. The doctor is saying that Prolia is not the cause of my pain. But I know my body and I say Prolia did this and will continue to cause people grief.

Picture of <span class="username">Guest (not verified)</span>

I am with you, I also know my 79 year old body, and know that Prolia has caused my problems. Imagine all of the people that do not report or are even aware that Prolia is causing them pain.

Picture of <span class="username">Guest (not verified)</span>

I'm very sorry for your loss. How disgusting that this poison is being marketed to millions of unsuspecting people. Someone at my docs office tried to get me to take prolia. I said no way. He said it wasn't him, referred me to a rheumatologist and said to do a diligent search to figure out a secondary cause for my case. I will be doing natural treatments only until something better comes along. Weight bearing Exercuse, calcium in diet and supplements Vit d with k2, magnesium in minerals and more. I may try hrt again. It's certainly safer than these drugs. It doesn't take a genius to figure this out. Just read about all of the horrific side effects as well as causing fractures and stopping bond production. The very thing they're supposed to help with. Prolia is a cancer drug not an osteoporosis drug. The FDA and big pharmacy have slot to answer for. This is a scam perpetrated on all of us.

Picture of <span class="username">Guest (not verified)</span>

I'm very afraid to take this shot. My bones are bad. But I've done research. The side effects are appalling. And read many bad things that happened to people taking this shot. I'm terrified. And many women wished they never took it. There has to a better method to helping this disease without this horrible side effects

Picture of <span class="username">Guest (not verified)</span>

Hi JoAnne, I refused Prolia when first offered to me by GP three years ago, however with a change of doctor that strongly suggested that I start on it, one injection only in April 2015 was all that I was prepared to take as the side effects set in on the fifth month. It has taken these last three months for these to start settling down.
I take Glucosamine & Chondroitin, maybe you could look into herbal medicine.

Picture of <span class="username">Guest (not verified)</span>

It is ten months (April 2015) since my one and ONLY injection, the main side effect that is has left me with is a very stiff neck with soreness running up the back of my skull, this was not with me before PROLIA, I just hope that this discomfort will leave with time.

Picture of <span class="username">Guest (not verified)</span>

Prolia shot on April 8 2016. Day 1 hoarseness day 3 rambling sounded like different person by end of week 1 hospitalized thought she was having heart attack Week 2 hospitalized couldn't move or walk. Week 3 rambling hands draw up insomnia. Week 4 ER. All of the above nothing compared to this week. Week 5. Brought home from psych center. Still not right. Family at a loss. We need some guidance and an attorney. Help please. Larry K and Sherri W in GA

Picture of <span class="username">Guest (not verified)</span>

Sherri! Your mother in law is following almost the exact footsteps that my dad did. I feel bad for your mother in law. Please keep us all posted. That is what helps others, even if it's just one person, possibly decide NOT to take this shot and be ruined. Hugs to all of you.

Picture of <span class="username">Guest (not verified)</span>

Sheri. So sorry to hear this. Heading in the same direction that my poor dad did after 1 shot. My dad got the hoarseness, severe shoulder and neck pain, started stumbling within a couple of days of the shot, fell and ended up in the hospital and from there a nursing home. 3 months into it, they also thought dad was having a heart attack. They were ready to put him on life support. He couldn't breathe. I insisted they check his blood calcium level as he was not on calcium or Vitamin D which is necessary. His levels came back as extremely low. they started supplements thru his IV and within 2 hours he started feeling better. The low blood calcium level gives symptoms of a heart attack. So sorry about your mother in law. Please keep us posted. I will be wondering about her.

Picture of <span class="username">Guest (not verified)</span>

My mother has been suffering terribly after taking one and only prolia shot
She has been very sick ever since she has taken this poison. It's 8 months after she was given the prolia injection and the horrible side effects are worse than ever. I advise all those who are thinking about taking prolia not to ever take it because the damage is great and the suffering is unbearable. I cannot believe how the FDA has approved such a dangerous biological drug that can have terrible effects on people.

Picture of <span class="username">Guest (not verified)</span>

My mother has been advised several times now to start with one injection Prolia, Denosumab per half year.
She is very scared of the side effects. After reading your stories I advised her not to start with this drug.
She will be 75 years old soon. So I believe you all agree that she shouldn't start this?

Picture of <span class="username">Guest (not verified)</span>

I had my first and ONLY shot of Prolia in September 2014 so any suggestion that once the drug is out of our bodies all will be well is an out and out illogical lie. The damage has already been done.

Following the shot had crushing pain in my ribs, bruising, rash, numb toes, and then UTI which looks to have turned into Interstitial Cysstitis. My eyes are playing up too. I am constantly nauseaus, rapid heartbeat and greatly fatigued. This drug is poison....and no one will listen. Tried to warn my sister but she believed the doctor's extolling of its virtues and people like us as "all in our heads".

Does it ever completely resolve, ever? Can't take much more. Back to the doctor tomorrow only to be told the same old same old...it's not Prolia. IT IS PROLIA I KNOW MY BODY. What can we do? I'm desperate.

Picture of <span class="username">Guest (not verified)</span>

I am so sorry for all of you who have had such a horrible experience. I just had to speak up, though, in all fairness, as one for whom it has worked. I'm out of osteoporosis and into osteopenia. Grateful. Tried everything else except reclast which is a super heavy duty bone drug - nothing I tried worked until prolia. I only wish, with all my heart, it had worked for all of you.

Picture of <span class="username">Guest (not verified)</span>

I received my sixth shot of Prolia on March 16,2016.Approximately eight days after injection,I began experiencing crippling back pain, dizziness,nausea,heartburn,chest pain,and a sinus infection.It is now May 27,2016,and the back pain has got so debilitating,it hurts to sit,can barely walk,nothing I have tried has helped.The burning and pain in the bones in my spine is so bad,it has near crippled me.I also was treated for a UTI about 3 weeks ago.Have not had one of those in over 20 years.As soon as one infection clears up,another one starts.Prolia definitely has compromised my immune system. I looked back on calendar to September 2015, days after receiving Prolia injection,began experiencing severe jaw pain,could not even chew food.Dentist suggested an orthotic to wear,maybe I would get relief.Paid 3500.00 for orthotic and that caused more jaw pain.I returned it,but only was refunded 1000.00.About two weeks after Prolia injection,the back pain started.Went to chiropractor,was given prednisone injection.Nothing relieved the back pain.Had flu like symptoms,a sinus infection,chest pain,was so dizzy,I would almost fall down.Never putting together all that was happening to me and Prolia injection.Prolia is the ONLY medication I take,so I know none of this was caused by something else.Received an injection of Prolia on August 21,2014.Same exact symptoms,dizziness,nausea,severe back and neck pain,constant infections.Had I not looked back on my calendars,I never would have put all this together.I could not imagine what kept happening to me,one illness and pain after the other,constant prednisone injections.Prolia has literally ruined my life.I am only 59 and feel like I am 100.No energy,constant debilitating pain and infections.If you are ever offered this medication,turn it down.Do not take the shot.Once it is in your system,you have to suffer the side effects for as long as it stays in your system,and maybe longer,I don't know.I am going for injections in my spine Wednesday,hoping I get some kind of relief,so I am able to walk better.Thinking back,the back and neck pain that I have,where it is my bones started after starting Prolia.I was very active before starting Prolia.This drug has near crippled me.I will never take another osteoporosis medicine.I will deal with a broken back first.

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