FDA Adds Boxed Warning to Prolia, Cautions Medication Could Cause Severe Hypocalcemia

Patients with mineral or bone disorders or who suffer from chronic kidney disease and take Prolia are particularly at risk for developing the illness.

The U.S. Food and Drug Administration (FDA) in White Oak, Md., on June 5, 2023. Madalina Vasiliu/The Epoch Times

Prolia (denosumab), a medication prescribed to treat osteoporosis, will now come with a boxed warning that taking it could increase a patient’s risk of developing low blood calcium levels, a condition known as hypocalcemia.

Patients with mineral or bone disorders or who suffer from chronic kidney disease and take Prolia are particularly at risk for developing the illness. According to the U.S. Food and Drug Administration (FDA), severe hypocalcemia can present with symptoms or without; common symptoms include the following:

• Confusion.
• Seizures.
• Arrhythmia.
• Fainting.
• Facial twitching.
• Uncontrolled muscle spasms.
• Weakness.
• Tingling.
• Numbness.

Some patients with advanced chronic kidney disease were hospitalized, experienced life-threatening events, or died as a result of severe hypocalcemia.