In light of the possibility of serious consequences, such as hospitalisation and death, the FDA stated that it is investigating the risk of severe hypocalcemia among dialysis patients using denosumab (Prolia).
The FDA alluded to interim findings from denosumab maker Amgen’s ongoing safety trial, which revealed an elevated risk of hypocalcemia in patients with severe kidney disease, in a safety advisory released on Tuesday.
Men and postmenopausal women with osteoporosis participated in the safety trial, which was done as part of the first authorisation of denosumab. Separately, preliminary findings from an internal FDA study to investigate the potential connection more thoroughly revealed a “substantial risk for severe and symptomatic hypocalcemia” among dialysis patients using denosumab.
The FDA advised patients not to discontinue denosumab treatment without first speaking with their clinician. The FDA’s notification is meant to warn medical professionals and patients to the potential risk. Patients were advised to keep an eye out for low blood calcium symptoms, which can include unusual tingling or numbness in the hands, arms, legs, or feet; painful muscle cramps or spasms; voice box or lung spasms that may make breathing difficult; along with vomiting, seizures, or irregular heartbeat.
The FDA advised doctors to assess the benefits and drawbacks of denosumab treatment for patients receiving dialysis.
Denosumab should be combined with adequate calcium and vitamin D intake, frequent blood calcium testing, and possibly even more frequent monitoring than is now done, if this medication is employed.
Additionally, the FDA advised people to be on the lookout for hypocalcemia symptoms and to seek prompt medical assistance if they appear.
Denosumab was initially approved in 2010 for the treatment of postmenopausal women with osteoporosis who were at high risk for bone fractures. However, it has since gained approval for the treatment of men with osteoporosis, glucocorticoid-induced osteoporosis, and bone loss in patients receiving androgen deprivation therapy for prostate cancer as well as women receiving aromatase inhibitor therapy for breast cancer.
The medication, which is administered by injection every six months, stops the body’s osteoclasts from destroying bone by blocking the protein receptor activator of nuclear factor kappa beta (RANK). Under the brand name Xgeva, denosumab is also authorised to lower the risk of occurrences involving the bones in certain cancer patients.
For all patients taking denosumab for advanced kidney disease, the FDA stated that it would continue to monitor these safety risks. Nevertheless, it will convey its “conclusions and recommendations when we have concluded our investigation or have more material to provide,” in particular with people who are receiving dialysis.