Sunday, February 25, 2024

FDA Warning: Prolia

January 19, 2024, the US Food and Drug Administration released a drug safety communication about the osteoporosis medication Prolia (denosumab).

If you have chronic kidney disease and use Prolia (denosumab), make an appointment with your doctor ASAP to discuss which medication regimen is best for you.

The FDA recently announced that osteoporosis patients with chronic kidney disease (CKD) are at higher risk of developing dangerously low calcium levels (known as hypocalcemia) if they use Prolia. This is a particular concern for patients undergoing dialysis, or who have mineral and bone density disorder.

Do not stop taking your medication without talking to your doctor. If you are at risk, your doctor can prescribe an alternative treatment. Fortunately, calcium and vitamin D supplements might be enough to keep the likelihood of hypocalcemia low.

Low calcium levels can be very dangerous. According to the FDA’s 2023 safety review, patients with advanced CKD who took Prolia experienced very serious harm, including life-threatening events and death.

What Should I Look Out For if I use Prolia?

The FDA advises patients to be aware of the following symptoms:

  • Confusion
  • Seizures
  • Irregular heart rhythm
  • Fainting
  • Face twitching
  • Uncontrolled muscle spasms
  • Weakness, tingling, or numbness in parts of the body

You might not notice any symptoms until at least two weeks after the injection is administered. Your risk of harm is greatest between two and ten weeks after your dose, peaking at around five weeks.

This means if you start to feel unwell, even three months after your Prolia dose, you should get yourself to the doctor ASAP.

What Can I Do To Minimise My risk?

If you are already undergoing treatment with Prolia, it is worth getting regular check-ups and to maintain your Calcium and Vitamin D levels.

Do not stop using Prolia without talking to your doctor, the danger of rebound fractures is high.

While the consequences of hypocalcemia can be harmful, with monitoring and care, most patients can still use this treatment safely. Your doctor is best placed to help you balance the risks from low calcium versus the risk of fractures.

Please read the FDA notice here:

Research C for DE and. FDA adds Boxed Warning for increased risk of severe hypocalcemia in patients with advanced chronic kidney disease taking osteoporosis medicine Prolia (denosumab). FDA. Published online January 19, 2024. Accessed January 22, 2024. https://www.fda.gov/drugs/drug-safety-and-availability/fda-adds-boxed-warning-increased-risk-severe-hypocalcemia-patients-advanced-chronic-kidney-disease

Joanna Mulvaney PhD
Joanna Mulvaney PhD
Joanna Mulvaney worked as a bench researcher for much of her career before transitioning to science communication. She completed a PhD in developmental biology focusing on cell signaling in cardiogenesis at the University of East Anglia, Norwich, UK, before moving on to study axial skeleton development and skeletal myogenesis at King’s College London and regeneration of auditory cells in the ear at University of California San Diego Medical School, USA and Sunnybrook Research Institute, Toronto, Canada. When it comes to scientific information, her philosophy is: make it simple, make it clear, make it useful.
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