Prolia Problems with Bone Fractures Comparable To Those Linked To Fosamax, Study Finds

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Amid continuing concerns about the link between Prolia and bone fractures, the findings of a new study suggests that the risk of problems with Prolia are similar to those seen in prior years with the other osteoporosis drug Fosamax, where users report suffering hip fractures and other bone fractures with little or no trauma.

In a study published this month in the medical journal JAMA Network Open, researchers from Denmark compared the three-year incidence of hip fractures and other types of fractures between Prolia and Fosamax, finding that the rate of problems was comparable between the two bone drugs.

Prolia (denosumab) was introduced by Amgen in 2010, and was the first drug approved by the FDA for the treatment of postmenopausal osteoporosis.

Fosamax (Alendronate) is an older osteoporosis drug introduced in 1995, which has been linked to an increased risk of atypical bone fractures, typically involving falls from standing height or less, resulting in the FDA requiring updated warnings about the risk of sudden bone fractures in 2010.

In 2013, the prominent consumer watchdog group Public Citizen raised concerns that the side effects of Prolia may increase the risk of low-trauma fractures, indicating that the drug appears to interfere with bone metabolism and the body’s immune system, resulting in breaks that may occur in situations that would not typically result in such an injury.

Although Amgen issued warnings about the Prolia bone fracture problems in Canada as early as 2012, concerns have been raised that insufficient warnings are still being provided in the United States.

Earlier this month, Public Citizen filed a petition with the FDA calling for the agency to require a “black box” Prolia fracture warning, which would be the strongest warning the drug maker could be required to add to the label.

In this new report, researchers conducted a population-based cohort-study using data on more than 92,000 individuals 50 years or older in Denmark from May 2010 to December 2017.

According to the findings, the three-year cumulative incidence of hip fracture with Prolia was 3.7%, compared to 3.1% with Fosamax, an older osteoporosis drug. The study also found that the three-year cumulative incidence of any fracture was 9% for both.

“In this nationwide cohort study based on routinely collected data in Denmark, treatment with denosumab and alendronate were associated with similar risks of hip and any fracture over a 3-year period,” the researchers concluded. “Sex, age, and fracture history were not associated with patients’ risk.”

Amgen has acknowledged that there users face an increased risk of fractures after stopping the drug, but company has indicated that it believes the benefits to patients outweigh the risks. However, Public Citizen’s petition says the science is pointing to those risks being bigger than first believed.

As more consumer learns that problems suffered in recent years may have been avoided with stronger warnings, it appears likely that Amgen may face Prolia bone fracture lawsuits, raising allegations similar to those presented in several thousands Fosamax lawsuits in prior years.

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  1. Kathleen A Reply

    I had osteopenia and fractured my hip in a fall. I had a Total hip replacement. 3 MDs encouraged me to take Prolia and I was reluctant but started it 9 months after the surgery. At 1 Year and 3 months post op February 2019,I starting have mid femur pain in operative leg. It was intermittent. In May I had a bone scan which suggest early loosening.
    I’m concerned about the Prolia, I have had 2 injections so far. I can’t find anything in the literature.

  2. pat Reply

    I took prolia injections for 1 1/2 years after hip fracture. Disastrous side effect, it caused my upper hard pallet and jawbone to disintegrate…spawned a tumor from the roof of my mouth to my left sinus cavity. Thank God the tumor was benign but now I have no teeth upper and the front two bottom, this was the most painful thing I have ever gone through. Does Amgen care that their product did this, and I am sure I am not alone.

  3. Kimberly Reply

    In May I took a minor fall & had no damage not even a skinned knee; nothing. Two weeks later sever pain on my right rib cage sent me to xray. I have a fracture. Four months later it is not healing. Hard to breath, move & function. In the mean time I lost lower right pre-molar eating a soft mint. $2700 later the hole has been prepped for implant. While healing from oral surgery I lost the left side pre-molar. Otherwise my teeth are healthy. I’m sure the remarkable tooth loss is a function of Prolia side-effect. To restore my mouth it is costing upwards of $4800 per tooth. Needless to say I’m furious & think Prolia must be incentivizing doctors to prescribe it. It’s unconscionable to give this deleterious chemical to anyone. I feel like a lab rat.

  4. David Reply

    My mom stopped taking Prolia and six months later was debilitated by 4 spinal fractures one right after another. Now she has been told this similar situation is not uncommon by doctor???? Now I start looking into this more and find hundreds of similar situations on-line. This drug took her from kicking soccer balls with my son one year to being almost immobile. A class action needs to be started and sounds like it will. This is criminal what has occurred to so many.

  5. Nancy Reply

    My husband died as a result of this drug. He received his 1st and only injection in August 2018 passed away December 2018. This drug needs to be taken off the market and a class action lawsuit needs to be filed.

  6. Pauline Reply

    I have been on prolia for over 5 years . Since starting it I have had two vertebrae fractured in September 2017, two January 2019 and 6 March 2019. I was late taking one shot in October 2018 and took it in April 2019. No one ever told me if I was late taking a shot it increased my risk for fractures. My back is in constant pain and I am still in an osteoporosis state. My Endocrinolgist is changing my therapy to a new drug in February.

  7. Suzanne Reply

    I was told to take this horrible drug after taking Fosamax for 3 months which did not agree with me. I am so glad I didn’t take it reading these awful stories. These are people’s lives and it’s not good enough that these drugs are pushed on us by professionals.

  8. Maureen Reply

    I was prescribed to get the Prolia shot done by an injection practice. I was not told any negative effects, I was handed a disclosure sheet and advised to read it before I had the shot , which I did. It was very strange to read that a product that was developed to stop bone loss and fractures could, in fact , cause more of them. I had 1 shot and then 4 months later I started having ALL of my teeth ache at the same time. Then I started to lose my teeth one .at a time. It was terrible! I even swallowed the top half of one of them. Most of them broke off the top and the roots are still buried in my jaw. I had no pain and no problems with the teeth before hand. As of this time, I have one very loose tooth and I have at least 6 set of roots buried under the gums that cause very little pain. I went to an oral surgeon for a price to fix the problems cost will be at least 5 thousand that I don’t have. This problem was NOT listed on disclosure sheet.

  9. Kimberly Reply

    I was receiving Prolia injections for 5 years for the treatment of osteopenia and osteoporosis. It was my understanding that I could be on it for 5 years. I also take a calcium supplement and D3. 12 months after my last Prolia injection I developed back pain and had difficulty walking. My MRI showed multiple vertebrae fractures. I had no injury and I could not understand how I went from a very active person to someone with constant back pain and difficulty walking. I soon found out after reading numerous articles about discontinuing Prolia. I wish my doctors and myself would have done more research.

  10. Grace Reply

    I have been given Prolia injections for quite some time. I used to have Fosamax, then a Aclasta infusion, my doctor said that the Prolia was much better than the Aclasta, because it was just one injection, compared with the inconvenience of 3/4 of an hour of sitting through the infusion. I was informed my last bone density was 4 years ago, so my doctor has sent me for a recent one, at another hospital, as it is a newer machine & she has had blood tests taken & asked me why I changed to prolia, I said because of what the other doctor had said. I have terrible pain in my back, legs, hands wrist & individual fingers. Unable to do many crafts/sewing & general home duties. So sorry I went down this path.

  11. Tambra Reply

    I had a laundry list of chronic conditions that my rheumatologist was familiar with. After two shots I told my rheumatologist I wanted to stop the injections. He kept telling me it was gong to be worse if I didn’t take Prolia. I kept refusing and he continued to push the drug on me. I told him of the side effects directly related to Prolia with printed information and still he refused to listen. I don’t just have asthma now, I also have asthma related COPD. The asthma got worse as well as the added COPD symptoms and I’ve never smoked in my life. I also have eczema because of it. I’ve never had eczema before the Prolia. I have TMJ and it’s worse. Recently, I’ve had five months of iron infusions for anemia which has never been this bad before. I started Prolia in early 2016 and finally got off of it in September 2017. The medical issues continue and I’m furious. We need justice and compensation. Even with my chronic health conditions Prolia has stolen more of the quality of life I had before it. Someone needs to take the side effects of this drug seriously and come up with a solution to restore the health taken away from the patients forced by doctors who care about the drug companies than their patients.

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