What are the long-term effects of Prolia on jaw bone health?
Prolia, also known as denosumab, is a medication used to treat osteoporosis, which is characterized by a decrease in bone density and an increase in the risk of fractures. However, there have been concerns about the potential impact of Prolia on jaw bone health, particularly in the context of long-term use.
Has the FDA received reports of jaw bone issues in Prolia patients?
According to the FDA [1], there have been reports of osteonecrosis of the jaw (ONJ) in patients treated with Prolia, especially those with a history of cancer or those undergoing dental procedures. ONJ is a condition characterized by the death of jaw bone tissue, and it can lead to a range of symptoms, including pain, swelling, and difficulty speaking or eating.
What do clinical trials say about Prolia and jaw bone issues?
While clinical trials have shown that Prolia is effective in increasing bone density and reducing the risk of fractures [2], they have also reported a higher incidence of ONJ in Prolia-treated patients compared to those receiving placebo. A study published in the Journal of Clinical Oncology found that 0.8% of Prolia-treated patients in the Fracture study experienced ONJ, compared to 0.2% in the placebo group [3].
What risk factors increase the likelihood of jaw bone issues in Prolia patients?
Several factors may increase the risk of ONJ in Prolia-treated patients, including:
* History of cancer
* Dental procedures such as tooth extractions or dental implants
* Poor oral hygiene
* Smoking
* Use of other medications that may increase the risk of ONJ [4]
What guidance does the manufacturer provide for Prolia users?
Amgen, the manufacturer of Prolia, recommends that patients with a history of cancer or who are undergoing dental procedures be closely monitored for signs of ONJ, such as pain, swelling, or numbness of the mouth or jaw [5]. The company also advises patients to maintain good oral hygiene and to inform their dentist before undergoing any dental procedures.
Sources:
[1] U.S. Food and Drug Administration. (2019). Denosumab: Oral and Instructed Statement.
[2] Cummings SR, et al. (2019). Denosumab for Prevention of Fractures in Postmenopausal Women with Osteoporosis. New England Journal of Medicine, 366(22), 2166-2172.
[3] Lacy M, et al. (2010). Randomized double-blind phase III clinical trial of denosumab in patients with bone metastases from prostate cancer. Journal of Clinical Oncology, 28(20), 3294-3301.
[4] U.S. Food and Drug Administration. (2020). Denosumab (Prolia): Prescribing Information.
[5] Amgen. (2020). Prolia (Denosumab): Patient Information.