FDA investigates risk of hypocalcemia for patients on dialysis using Prolia
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The FDA is investigating the risk of severe hypocalcemia in patients on dialysis treated with the osteoporosis drug Prolia, according to a drug safety communication.
The agency said hospitalizations and death have been reported among patients taking Prolia (denosumab, Amgen Inc.) due to hypocalcemia, according to the drug safety communication.
“Our review of interim results from an ongoing safety study of Prolia suggests an increased risk of hypocalcemia, or low calcium levels in the blood, in patients with advanced kidney disease,” the FDA wrote in the communication. “Preliminary results from a separate internal FDA study further investigating hypocalcemia in dialysis patients treated with Prolia show a substantial risk with serious outcomes, including hospitalization and death.”
The agency said it is alerting health care professionals about the risks because of the frequency and seriousness of the cases. “We will communicate our final conclusions and recommendations when we have completed our review or have more information to share,” the FDA wrote.
In a statement to Healio, Amgen wrote, “Patient safety is of the utmost importance at Amgen. We are aware of the FDA’s drug safety communication and are committed to collaborating with the FDA and other health authorities.”
The FDA said it had required Amgen to conduct a long-term safety study in women with postmenopausal osteoporosis and men with osteoporosis after the agency approved the drug in July 2010. “Our review of the interim results from this ongoing safety study suggests an increased risk of hypocalcemia with Prolia in patients with advanced kidney disease,” the FDA wrote. “In addition, adverse event reports submitted to FDA showed severe and symptomatic hypocalcemia, including hospitalization and death, is occurring in patients with advanced kidney disease treated with Prolia.
“Preliminary results from a separate internal FDA study investigating the risk of hypocalcemia suggest that patients on dialysis treated with Prolia are at substantial risk for severe and symptomatic hypocalcemia, including hospitalization and death,” according to the FDA.
In safety information available on the Prolia website, the company wrote, “Preexisting hypocalcemia must be corrected prior to initiating Prolia ... hypocalcemia may worsen with the use of Prolia, especially in patients with severe renal impairment. In patients predisposed to hypocalcemia and disturbances of mineral metabolism, including treatment with other calcium-lowering drugs, clinical monitoring of calcium and mineral levels is highly recommended within 14 days of Prolia injection.”
The FDA wrote that patients should not stop Prolia treatment without first consulting a health care professional, “as stopping may worsen your bone condition. Talk to your health care professional about any concerns you may have, including possible alternative treatments.”
References:
FDA investigating risk of severe hypocalcemia in patients on dialysis receiving osteoporosis medicine Prolia (denosumab). www.fda.gov/drugs/drug-safety-and-availability/fda-investigating-risk-severe-hypocalcemia-patients-dialysis-receiving-osteoporosis-medicine-prolia?utm_medium=email&utm_source=govdelivery. Published Nov. 22, 2022. Accessed Nov. 28, 2022.
Important safety information for Prolia. www.proliahcp.com. Accessed Nov. 28, 2022.
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