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Denosumab (PROLIA) was approved by the Food and Drug Administration (FDA) in 2010 to treat osteoporosis in postmenopausal women with an increased risk of fractures. Public Citizen’s Health Research Group petitioned the FDA for a black-box warning in the product labeling for this drug[1] and also has designated it as Do Not Use because its serious risks (including hypersensitivity reactions, increased risk of serious infections, adverse skin reactions, and risk of multiple vertebral fractures...
Denosumab (PROLIA) was approved by the Food and Drug Administration (FDA) in 2010 to treat osteoporosis in postmenopausal women with an increased risk of fractures. Public Citizen’s Health Research Group petitioned the FDA for a black-box warning in the product labeling for this drug[1] and also has designated it as Do Not Use because its serious risks (including hypersensitivity reactions, increased risk of serious infections, adverse skin reactions, and risk of multiple vertebral fractures after stopping the drug) outweigh its benefits.[2] Denosumab also has been shown to cause hypocalcemia (decreased blood calcium levels).
On Nov. 22, 2022, the FDA announced in a Drug Safety Communication that it was investigating the risk of severe and symptomatic hypocalcemia in patients with advanced kidney disease, particularly those on dialysis, who received treatment with denosumab.[3] Hypocalcemia can lead to serious outcomes, including hospitalization and death. The FDA will continue to monitor this potential safety issue and announce its final conclusions and recommendations at a future date.
If you are taking denosumab, and especially if you have advanced kidney disease, tell your health care professional right away if you experience any symptoms of hypocalcemia, including unusual tingling or numbness in the hands, arms, legs, or feet; painful muscle spasms or cramps; difficulty breathing; vomiting; seizures; or irregular heart rhythm.
Do not stop taking denosumab without consulting your health care professional, as stopping suddenly can lead to serious adverse effects. If you have advanced kidney disease, talk to your doctor about alternative treatments for your osteoporosis.
Report any adverse effects caused by denosumab to the FDA’s MedWatch program by calling 1-888-463-6332 or going to https://www.fda.gov/MedWatch.
References
[1] Public Citizen. Petition to the Food and Drug Administration for a boxed warning on denosumab (PROLIA). https://www.citizen.org/wp-content/uploads/2478.pdf. Accessed February 23, 2023.
[2] Review of the osteoporosis drug denosumab (PROLIA). Worst Pills, Best Pills News. April 2019. https://www.worstpills.org/newsletters/view/1256. Accessed January 30, 2023.
[3] Food and Drug Administration. FDA Drug Safety Communication: FDA investigating risk of severe hypocalcemia in patients on dialysis receiving osteoporosis medicine Prolia (denosumab). November 22, 2022. https://www.fda.gov/drugs/drug-safety-and-availability/fda-investigating-risk-severe-hypocalcemia-patients-dialysis-receiving-osteoporosis-medicine-prolia. Accessed January 30, 2023.
