The U.S. Food and Drug Administration (FDA) has issued a significant warning regarding Amgen’s drug Prolia, used to treat bone loss, due to an increased risk of severely low calcium levels in certain patients.
This critical alert, known as a boxed warning, was released on Friday following an FDA review initiated in 2022.
The investigation specifically focused on the risk of very low blood calcium levels in patients with advanced chronic kidney disease, especially those undergoing dialysis, who were using Prolia.
During the review, the FDA examined 25 cases spanning from July 2010 to May 2021.
Boxed warnings are the strictest warnings that the FDA issues, signifying the potential for severe side effects associated with a drug’s use.
Prolia received FDA approval in 2010 for the treatment of bone loss in postmenopausal women and later gained approval for use in both men and women at high risk of fractures.
It generated a total of $986 million in sales in the third quarter, but its U.S. patent is set to expire in February of the following year.
Notably, other medications used to address bone loss or osteoporosis, such as Merck’s Fosamax and Amgen’s Xgeva and Evenity, already include safety information warning against prescribing the drug to patients with kidney disease.
Kidney disease often results in low calcium levels, and these drugs can potentially lead to severe injury or even death in affected patients.
As a result of this FDA warning, Amgen’s shares experienced a marginal decline on Friday.
It is crucial for healthcare professionals and patients to be aware of the heightened risk of low calcium levels associated with Prolia, particularly in individuals with advanced chronic kidney disease or those undergoing dialysis.
This cautionary measure underscores the importance of vigilant monitoring and informed decision-making when considering the use of Prolia in such patient populations.