2024-01-22| Trials & Approvals

FDA’s Boxed Warning Highlights Low Calcium Dangers with Prolia

by Sinead Huang
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The U.S. Food and Drug Administration (FDA) has added a significant warning to the prescribing information for Amgen’s drug Prolia, designed to treat bone loss. The newly introduced boxed warning emphasizes the heightened risk of severely low calcium levels in specific patient groups. This regulatory action follows a comprehensive review initiated by the FDA in 2022, focusing on patients with advanced chronic kidney disease, especially those undergoing dialysis, and their use of Prolia.

Related article: Amgen Faces Class Action Lawsuit for Concealing $10.7 Billion Tax Bill to Manipulate Stock Price

Thorough Examination Prompts FDA Warning for Prolia

The FDA’s decision to issue a boxed warning stems from a thorough examination of 25 cases documented between July 2010 and May 2021. The investigation specifically targeted the risk of very low blood calcium levels associated with Prolia usage in individuals with advanced chronic kidney disease. Boxed warnings are the most stringent cautions issued by the FDA, signaling potential serious side effects linked to a drug. In this case, the emphasis is on the risk of low calcium levels, a critical health concern.

Upcoming Patent Expiry and FDA Caution Impact Amgen’s Prolia

Amgen’s Prolia, initially approved in 2010 for treating bone loss in postmenopausal women, later gained approval for use in both men and women at high risk of fractures. Despite its efficacy, the drug faces a notable commercial development as it is scheduled to lose its U.S. patent in February of the upcoming year. The FDA’s boxed warning comes at a crucial juncture, impacting Prolia, which reported total third-quarter sales of $986 million. The cautionary measures are essential to ensure patient safety and guide healthcare professionals in prescribing decisions.

The warning aligns Prolia with other drugs addressing bone loss or osteoporosis, such as Merck’s Fosamax and Amgen’s Xgeva and Evenity. These medications already include safety information cautioning against their prescription to patients with kidney disease. Given that kidney disease often results in low calcium levels, the use of these drugs in affected individuals could lead to severe injury or, in extreme cases, death. The FDA’s move underscores the importance of informed and cautious prescribing practices, especially for drugs with potential risks in specific patient populations.

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