FDA Adds Black Box Warning to Prolia (denosumab) - MedWaste Management FDA Adds Black Box Warning to Prolia (denosumab) - MedWaste Management

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Prolia (denosumab) FDA black box warning

FDA Adds Black Box Warning to Prolia (denosumab)

 

The FDA has announced the addition of a black box warning to Prolia (denosumab), a drug often prescribed for osteoporosis. The warning is to alert healthcare providers and patients that the drug increases the risk of severe hypocalcemia (low calcium levels), particularly in patients with chronic kidney disease (CKD) who are on dialysis. The severity of the hypocalcemia has the potential to lead to life-threatening events or death.

Patients receiving Prolia (denosumab) who are diagnosed with chronic kidney disease (CKD) should discuss the warning with their doctor.

SUMMARY

Date of Warning:

Announced: January 19, 2024

Public Notification: January 19, 2024

Name(s) of Drug:

Prolia (denosumab)

Company Name:

All manufacturers

Brand Name:

All manufacturers

Drug Indication:

Osteoporosis

 

Product Description

Prolia (denosumab) is a prescription medication used to treat postmenopausal women with osteoporosis. It is also prescribed for men to increase bone mass and is used in conjunction with certain cancer treatments. The drug is administered by a medical professional by subcutaneous injection once every six months.

Reason for Warning

The FDA completed an evaluation of studies conducted by the Centers for Medicare & Medicaid Services (CMS) and 25 cases submitted between July 2010 and May 2021. They found a significant increase in the incidence of complications associated with hypocalcemia (low calcium levels), including arrhythmias, confusion, seizures, face twitching, and muscle spasms in those with chronic kidney disease, especially when dialysis-dependent.

Impacts

Patients with chronic kidney disease who are dialysis-dependent are at a higher risk of developing hypocalcemia (low calcium levels). This can lead to symptoms and outcomes such as:

  • Muscle spasms or twitching
  • Muscle cramping
  • Numbness or tingling in fingers or toes
  • Weakness
  • Fainting
  • Irritable mood
  • Confusion or disorientation
  • Seizures
  • Irregular heart rhythm
  • Death

The risk for developing severe hypocalcemia mainly occurs 2-10 weeks following the injection. However, it may happen earlier or later for some.

Lot Information

All lots and brands of Prolia (denosumab) are included in the warning.

Do you receive Prolia (denosumab) injections? Here’s what you should do.

Patients

  1. Call your physician to discuss your use of Prolia.
  2. Do not stop taking your medication without discussing it with your physician first.
  3. Seek medical attention immediately if you develop any symptoms of hypocalcemia, including confusion, seizures, irregular heart rhythm, fainting, twitching, muscle spasms, numbness, weakness, or tingling in your body.
  4. If you are currently experiencing or have experienced an adverse reaction to this medication (listed above), notify your physician immediately and notify the FDA by calling 1-800-332-1088 or completing an online reporting form.

 

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Tammy McKinney, Nurse and Healthcare Writer Byline Image

 

Tammy McKinney, RN, creator of HelpfulHospiceNurse, is a healthcare writer and seasoned registered nurse. With experience in acute care, long-term care, rehabilitation, drug and alcohol, and hospice and palliative care, she combines her medical understanding with her love for writing to educate and inform the public on various health-related topics. You can view a snippet of her portfolio here or contact her directly on LinkedIn!

 

One response

  1. harley davidson insurance Avatar

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