WASHINGTON, D.C. — The public consumer watchdog group called First Citizen has filed a petition with the U.S. Food and Drug Administration regarding the osteoporosis drug Prolia (denosumab). First Citizen asked the FDA to compel Amgen, the company that manufacturers Prolia, to recall the product based on scientific evidence connecting Prolia to fractured vertebrae. As an additional remedial measure, First Citizen asked the FDA to order Amgen to include a “black box warning” on the Prolia packaging coupled with an increased risk evaluation and risk mitigation strategy for use before physicians prescribe Prolia to patients.
First Citizen petitioned the FDA for greater consumer protection from Prolia after research determined that the drug causes an increased risk of broken vertebrae in patients taking the drug. First Citizen claimed that the manufacturer of the drug, Amgen, buried information about the possibility of broken vertebrae in its packaging materials. First Citizen argues that such information must prominently appear on the labeling. Accordingly, the watchdog group called upon the FDA to order Amgen to include a warning about the increased potential for broken vertebrae in a “black box warning.” A black box warning will call physicians’ and consumers’ attention to the issue, thereby allowing them to assess the potential benefits while considering the possible side effects.
A spokesperson for Amgen said that the company is aware of data generated through testing indicating that there is an increased risk of a patient suffering fractured vertebrae while taking Prolia. Notwithstanding, the Amgen spokesperson said that the benefits of taking Prolia far outweigh the risks. Additionally, the Amgen spokesperson told Fierce Pharma that the company continues to work very closely with regulators and has been completely transparent with them regarding the heightened risk of vertebral fractures in patients who once took Prolia.
First Citizen acknowledged that the FDA had noted the risk of vertebral fractures when taking Prolia. However, First Citizen said that the FDA needs to do more to inform doctors and patients of the risk.
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