Amgen Osteoporosis Drug Prolia Is Hit With FDA’s Strictest Warning


FDA issued new black box warning for Amgen’s osteoporosis drug Prolia due to risk of severe hypocalcemia, especially in patients with advanced kidney disease. This warning comes after studies showed increased risk compared to older osteoporosis drugs. FDA alert stemmed from review of long-term testing. To mitigate risk, FDA advises adequate calcium and vitamin D intake for Prolia patients, and frequent monitoring of calcium levels for those with advanced kidney disease. Amgen’s newer osteoporosis drug Evenity also carries this risk. FDA also approved new treatments for beta thalassemia and PNH, and a subcutaneous version of Roche cancer drug Tecentriq, but rejected Satsuma Pharmaceuticals’ migraine treatment and Astellas Pharma’s zolbetuximab due to manufacturing issues.

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