Prolia Femur Fracture Warning Issued to Doctors in Canada

A warning has been provided by Canadian health officials about the potential risk of sudden femur fractures associated with side effects of Prolia, an osteoporosis drug sold by Amgen. However, it does not appear that similar warnings have been provided to doctors in the United States.

Health Canada and Amgen Canada, Inc. issued a warning letter (PDF) last month, informing health care providers in Canada that some users of Prolia have suffered atypical femur fractures, which can occur with little or no trauma to the thigh bone.

The sudden fractures appear to be similar to those associated with the side effects of Fosamax and other bone-strengthening drugs that are part of a class of medications known as bisphosphonates. However, Prolia does not belong to that family of drugs.

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Health Canada and Amgen warn that if a patient using Prolia experiences any new pain in the thigh, hip, or pelvic area, they should contact their health care provider immediately. The label for Prolia has been updated to include the new warning information.

According to Amgen, Prolia femoral fractures have been confirmed among patients who are part of an ongoing study to extend the use of of the drug for postmenopausal osteoporosis.

The fractures appear to occur in one out of every 10,000 patients that use the drug. In most cases the fractures produce a dull, unusual aching pain in the thigh, hip, or pelvis area.

While Prolia is sold in both the United States and Europe, there have been no similar warnings by the FDA or the European Medicines Agency (EMA). However, there have been warnings for other bone drugs.

Merck & Co. currently faces hundreds of Fosamax femur fracture lawsuits that have been filed by individuals who claim the drug maker failed to adequately warn about the potential risk of problems.  Complaints allege that side effects of Fosamax may weaken the ability of the femur bone to repair itself from microdamage, increasing the risk of a sudden femur fracture.

In October 2010, the FDA required the Merck and the manufacturers of other bisphosphonate medications approved for treatment of osteoporosis to add warnings about the risk of sudden femur fractures. Since then, information has been provided in a Medication Guide distributed with each prescription for the drugs, warning consumers to contact their doctor if they experience new thigh or groin pain, which can occur weeks or months before a complete femur fracture occurs on the osteoporosis drugs.

7 Comments

  • LindaMarch 6, 2023 at 6:07 pm

    I had been on Prolia injections every 6 months since 2011. About July of 2000, I began to have sharp, stabbing pains in my right calf on the outside about 4 in. below my knee after lying in bed to go to sleep. I could not stay there for more than 2 hours. I would have to get up and sleep in the recliner to get any sleep. I kept telling the doctors that my leg was going to crumble and fall off. [Show More]I had been on Prolia injections every 6 months since 2011. About July of 2000, I began to have sharp, stabbing pains in my right calf on the outside about 4 in. below my knee after lying in bed to go to sleep. I could not stay there for more than 2 hours. I would have to get up and sleep in the recliner to get any sleep. I kept telling the doctors that my leg was going to crumble and fall off. That's exactly what happened on March 10,2022. I was standing perfectly still and it just happened!!!! The pain was excruciating!!!! I was flown 84 mi. to Memphis and had 2 surgeries in 3 days. I had blood clots in my lungs and bowel complications while there. When I was transported back to Jackson(TN) I went to a nursing home for pt. I vomited green for 6 hours and someone FINALLY came in and said, "Stop pushing that button every 5 min.,I have a meal to serve"!!! My husband called an ambulance to take me to the hospital. They could not do surgery due to swelling and because I was on blood thinner. I was having an acute pancreatitis attack and a gallbladder attack, neither of which I have never had before. Then I went to another nursing home for pt and they left me unattended in the bathroom and I fell and broke my tailbone!! I just recently finished pt the end of Feb. I haven't driven yet and on this coming Fri. Mar.10,2023 it will be an entire year.I have spent MONTHS trying to find an attorney to take my case! I have called allover the country! I am so tired and disgusted.It's just not fair. Thank you and God Bless My statue of limitations is running out!

  • JudyDecember 26, 2021 at 12:05 pm

    I have been on Prolia for about 9 years. I recently stopped these shots due to dental surgery. My Endo did not advise me of any possible problems when he stated that going off this drug was no problem. To date, 5 months after my first missed shot I now have 12 compression fractures in my back with incredible pain. This could have all been prevented.

  • CarrieMay 18, 2021 at 2:43 am

    My mother, in her 70s, has been given Prolia by injection in her doctor's office for 10 years. She has now been told she may have to have her jaw removed as it has deteriorated due to the drug. If anyone is aware of a class action law suit please let me know.

  • NancyMay 16, 2019 at 12:07 pm

    Last year I had one injection of Prolia. I have had devastating side effects of this drug. First Within weeks I lost half the hair on my head, it came out in hand fulls like what you see after a chemo or radiation treatment, after 1 year it has not grown back fully. I developed sores in my mouth which continue to reoccur ever few months. My teeth broke off in my mouth. I lost a total of three and [Show More]Last year I had one injection of Prolia. I have had devastating side effects of this drug. First Within weeks I lost half the hair on my head, it came out in hand fulls like what you see after a chemo or radiation treatment, after 1 year it has not grown back fully. I developed sores in my mouth which continue to reoccur ever few months. My teeth broke off in my mouth. I lost a total of three and 2 others chipped. I can not get 2 out of the 3 broken replaced and they are molars so now my teeth are shifting and I have problems chewing. I still have one in my mouth that is broken under the jaw line the orthodontic dentists want thousand of dollars to remove it and many of them won’t even consider removing it because I have taken Prolia. 3 weeks after I took the drug developed such severe bone pain I could barely walk. I have always had Scoliosis but with in s few months after I took Prolia I started To notice my right leg was becoming shorter then my left one and my hip bone was turning outward on my left side. One year after using Prolia I have lost almost 2 inches height on the right side and my left hip appears turned outward. This is a horrible horrible drug it should be removed from the market.

  • AnitaApril 12, 2019 at 4:34 pm

    I lost all of my teeth..my Oral Surgeon made me aware of the danger when I went to him after for no reason my teeth started falling out..Now I have one front tooth left..and there is great danger to go through oral surgeon..I was told that I'm in great risk of my jaw falling out..google Osteocranosis..frightening pictures..

  • SheilaDecember 13, 2017 at 3:04 pm

    Apparently, https://www.rxlist.com/prolia-drug/patient-images-side-effects.htm "loose teeth" I have all reports from the doctors and Xrays to show the damage that prolia has done to my teeth (now I cannot ever have any metal touch my gums - my teeth broke in pieces). The Endocronologist wrote a report to my Health Administrators and I had to pay to buy a bridge to replace the teeth that were goo[Show More]Apparently, https://www.rxlist.com/prolia-drug/patient-images-side-effects.htm "loose teeth" I have all reports from the doctors and Xrays to show the damage that prolia has done to my teeth (now I cannot ever have any metal touch my gums - my teeth broke in pieces). The Endocronologist wrote a report to my Health Administrators and I had to pay to buy a bridge to replace the teeth that were good - nothing wrong with them. Health Canada has been warned A warning has been provided by Canadian health officials about the potential risk of sudden femur fractures associated with side effects of Prolia, an osteoporosis drug sold by Amgen. However, it does not appear that similar warnings have been provided to doctors in the United States. Here is a warning https://www.lexi.com/individuals/dentistry/newsletters.jsp?id=august_ https://www.lexi.com/individuals/dentistry/newsletters/ Health Canada and Amgen Canada, Inc. issued a warning letter (PDF)

  • JannSeptember 12, 2015 at 7:28 pm

    Starting in 2010 I experienced severe hip, groin, pelvis and leg pain during the 1st year of the shot of Prolia. Had the second shot and immediately my doctor said no more. Started experiencing jaw pain, bone loss and eventually lost all my bottom teeth. Too many problems for my own good. 2015 experiencing back problems and my spinal doctor discovered a condition in both of my femers which he b[Show More]Starting in 2010 I experienced severe hip, groin, pelvis and leg pain during the 1st year of the shot of Prolia. Had the second shot and immediately my doctor said no more. Started experiencing jaw pain, bone loss and eventually lost all my bottom teeth. Too many problems for my own good. 2015 experiencing back problems and my spinal doctor discovered a condition in both of my femers which he believes is the result of my use of Prolia. I will be monitored regularly for fracturing.

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