Certain Patients Taking Prolia (Denosumab) Could Be Facing Severe Side Effects

Prolia is a medication commonly used to treat Osteoporosis. Although it is recommended by doctors, some patients are more at risk of experiencing severe side effects from using the drug.

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Having more health issues is a part of getting older. For some, the aging processes brings new challenges like bone weakness. Prolia is a medication commonly used to treat Osteoporosis. This illness is a silent condition that weakens bones, making them fragile and more prone to fractures. Prolia aims to help those dealing with osteoporosis, however, those who also have chronic kidney failure can potentially deal with very bad side effects from using the drug.

Understanding Osteoporosis

Osteoporosis is characterized by decreased bone density and quality, leading to increased fragility and risk of fractures. The condition often progresses without symptoms until a fracture occurs, typically in the hip, spine, or wrist. It’s crucial to maintain bone health, especially as one ages, to prevent osteoporosis and its associated risks.

Osteoporosis back pain

What is Prolia?

Prolia was first approved to treat bone loss in postmenopausal women back in 2010 and then later approved to treat both men and women who were at high risk of bone fracture. Prolia contains denosumab, a monoclonal antibody that targets and inhibits RANK ligand (RANKL), a key protein involved in bone resorption. By blocking RANKL and inhibiting osteoclast cells, Prolia effectively slows down the process of bone breakdown, but still allows the osteoblast cells to build new bone.

Administration and Dosage

Prolia is administered through a subcutaneous injection once every six months, making it a convenient option for those seeking an alternative to daily or weekly osteoporosis treatments. Even with its flaws, this biannual regimen has been a game-changer for patients and healthcare providers alike.

Prolia Side Effects and Considerations

Prolia is a powerful treatment for osteoporosis and it’s recommended by a lot of doctors. However, like other bisphosphonates like Reclast or Fosamax, it’s not without major side effects. According to the FDA, “the osteoporosis medicine Prolia (denosumab) increases the risk of severe hypocalcemia, very low blood calcium levels, in patients with advanced chronic kidney disease (CKD), particularly patients on dialysis.”

Patients are advised to have their calcium levels checked before starting treatment and to take calcium supplements if necessary. Additionally, there have been reports of adverse cardiac events in patients using Prolia, particularly those with pre-existing heart conditions. This underscores the importance of a thorough medical consultation prior to beginning treatment with Prolia.

It is also not recommended to stay on Prolia for more than 10 years due to the risk of atypical fractures and osteonecrosis of the jaw. This is problematic, since according to Dr. Janet Rubin M.D., when you stop taking Prolia, some run the risk of losing bone at a faster rate right afterwards, compared to those who never took the medication. Dr. Janet Rubin also doesn’t recommend patients of a certain age to use the drug due to potential side effects. 

Risk of Denosumab Discontinuation

  • Rapid decline of bone density
  • Increase in fracture risk
  • Multiple vertebral fractures reported 

Change in Prolia's Warning Label

Prior to 2012, manufacturers did not adequately inform consumers about the risk of atypical femur fractures associated with this medication. However, starting in 2012, the medication’s labeling was updated to include warnings about these potential side effects. These side effects are particularly concerning as they can significantly reduce the quality of life of individuals who are taking the medication primarily to prevent bone fractures.

arm pain bone

Have You Been Negatively Affected by Prolia?

If you or someone close to you has suffered adverse effects from Prolia, reach out to our legal team immediately. We have a legal staff who are dedicated to supporting clients both in Texas and across the nation with their Prolia challenges. Our experienced attorneys will manage your case attentively, striving to achieve the most favorable outcomes for you and your family.

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