FDA Issues Boxed Warning For Osteoporosis Drug Prolia


The U.S. Food and Drug Administration (FDA) has issued a black box warning — reserved for the most serious safety issues — for the osteoporosis drug denosumab, sold under the brand name Prolia.

Patients with advanced chronic kidney disease run the risk of severe hypocalcemia — dangerously low blood calcium levels that can cause life-threatening side effects like seizures and heart failure — when they take denosumab, the FDA said in a January 19 statement.

“For patients with advanced kidney disease, especially those on dialysis treated with Prolia, frequent monitoring of calcium in the blood, especially for the first 2 to 10 weeks after each Prolia injection, is recommended,” the FDA said in the statement.

Symptoms that might indicate severe hypocalcemia include confusion, seizures, fainting, face twitching, uncontrollable muscle spasms, tingling or numbness in parts of the body, or an irregular heart rhythm, according to the FDA. People taking denosumab who experience these symptoms should contact their healthcare provider — especially if they have chronic kidney disease or are on dialysis, the FDA said.


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