Other safety alerts
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| The United States: FDA investigating risk of severe hypocalcemia in patients on dialysis receiving osteoporosis medicine Prolia (denosumab) |
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The US Food and Drug Administration (FDA) announces that it is investigating the risk of severe hypocalcemia with serious outcomes, including hospitalization and death, in patients with advanced kidney disease on dialysis treated with the osteoporosis medicine Prolia (denosumab). FDA’s 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. 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.
Because of the frequency and seriousness of these risks, FDA is alerting health care professionals and patients about them and is continuing to evaluate this potential safety issue with Prolia use in patients with advanced kidney disease, particularly those on dialysis. FDA will communicate the final conclusions and recommendations when the review is completed and there is more information to share.
Patients should not stop Prolia treatment without first consulting their health care professional, as stopping may worsen their bone condition. Talk to their health care professional about any concerns they may have, including possible alternative treatments. Tell their health care professional if they experience any symptoms of low blood calcium levels such as unusual tingling or numbness in the hands, arms, legs, or feet; painful muscle spasms or cramps; voice box or lung spasms causing difficulty breathing; vomiting; seizures; or irregular heart rhythm.
Health care professionals should consider the risks of hypocalcemia with the use of Prolia in patients on dialysis. When Prolia is used in these patients, adequate calcium and vitamin D supplementation and frequent blood calcium monitoring, possibly more often than is already being conducted, may help decrease the likelihood or severity of these risks. Advise patients on dialysis to immediately seek help if they experience symptoms of hypocalcemia.
When FDA first approved Prolia, it required the manufacturer, Amgen, to conduct a long-term safety study in women with postmenopausal osteoporosis and men with osteoporosis. FDA’s review of the interim results from this ongoing safety study suggests an increased risk of hypocalcemia with Prolia in patients with advanced kidney disease. 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.
Please refer to the following website in FDA for details:
http://www.fda.gov/drugs/drug-safety-and-availability/fda-investigating-risk-severe-hypocalcemia-patients-dialysis-receiving-osteoporosis-medicine-prolia
In Hong Kong, Prolia Solution For Injection In Pre-filled Syringe 60mg/ml (USA) (HK-60588) and Prolia Solution For Injection In Pre-filled Syringe 60mg/ml (The Netherlands) (HK-60589) are pharmaceutical products containing 60mg of denosumab which are registered by Amgen Hong Kong Limited. Both products are prescription-only medicines. So far, the Department of Health (DH) has received 62 cases of adverse drug reaction related to denosumab, of which 3 cases were related to hypocalcemia/serum calcium decreased.
Related news on the risk of hypocalcemia associated with the use of Xgeva (containing 120mg of denosumab) was previously issued by Health Canada and Singapore Health Sciences Authority, and was posted on the Drug Office website on 1 Jun 2012 and 8 Oct 2014. Letters to inform local healthcare professionals were issued by the DH on 1 Jun 2012. In Dec 2012, the Registration Committee of the Pharmacy and Poisons Board discussed the matter for Xgeva and Prolia, and decided that the sales pack label and/or package insert of denosumab products should include safety information about the risk of hypocalcemia (including in patients with severe renal impairment or receiving dialysis). The DH will remain vigilant on the conclusion of the review and any safety updates issued by other overseas drug regulatory authorities.
Ends/Wednesday, Nov 23, 2022
Issued at HKT 15:00
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