Is there a correlation between jaw pain and the use of Actonel (Risedronate)?

From the Guidelines

Yes, there is a correlation between jaw pain and the use of Actonel (risedronate), which is a bisphosphonate medication commonly prescribed for osteoporosis and Paget's disease. Actonel has been associated with a rare but serious side effect called osteonecrosis of the jaw (ONJ), which can cause jaw pain, swelling, infection, and exposed bone in the jaw area. This condition occurs when the jaw bone is damaged and dies due to reduced blood flow. The risk of developing ONJ while taking Actonel is generally low (estimated at 1 in 1,500 to 1 in 100,000 patients), but certain factors can increase this risk, including dental procedures (particularly extractions), poor oral hygiene, cancer, chemotherapy, corticosteroid use, and longer duration of bisphosphonate therapy 1. If you experience jaw pain while taking Actonel, you should contact your healthcare provider immediately. Do not stop taking Actonel without medical advice, as the benefits for treating osteoporosis often outweigh the risks. To minimize the risk of jaw complications, maintain good oral hygiene, have regular dental check-ups, and inform your dentist that you are taking Actonel before undergoing any invasive dental procedures 1.

Some key points to consider:

• The incidence of ONJ increases with extended durations of monthly IV bisphosphonates or subcutaneous RANK-L inhibitor, especially that exceeding 2 years 1.
• Schedules for osteoporosis prevention or treatment—for example, every 6 months—are associated with a much lower incidence (0% to 1%) of ONJ 1.
• With oral bisphosphonates, incidence on MRONJ is even less (0% to 0.5%) 1.
• Risk factors associated with ONJ include dental extractions, and therefore, dental examination and prophylactic measures should be considered before starting bisphosphonate therapy 1.

It is essential to weigh the benefits and risks of Actonel treatment and to take preventive measures to minimize the risk of jaw complications. Regular monitoring and open communication with your healthcare provider can help mitigate potential risks associated with Actonel use. By being aware of the potential correlation between jaw pain and Actonel use, you can take proactive steps to protect your oral health and overall well-being.

From the FDA Drug Label

WARNINGS AND PRECAUTIONS ... Osteonecrosis of the Jaw has been reported (5.4) Severe Bone, Joint, Muscle Pain may occur. Discontinue use if severe symptoms develop (5.5,6.2)

The use of Risedronate is associated with Osteonecrosis of the Jaw and Severe Bone, Joint, Muscle Pain, which may include jaw pain. Key points to consider:

• Osteonecrosis of the Jaw has been reported in patients taking Risedronate.
• Severe Bone, Joint, Muscle Pain may occur, and patients should discontinue use if severe symptoms develop. Based on the information provided, there is a potential correlation between jaw pain and the use of Actonel (Risedronate), as Osteonecrosis of the Jaw and Severe Bone, Joint, Muscle Pain are listed as possible adverse reactions 2.

From the Research

Correlation between Jaw Pain and Actonel Use

• There is no direct evidence in the provided studies that specifically links jaw pain to the use of Actonel (risedronate) 3.
• However, the studies suggest that bisphosphonates, including risedronate, can increase the risk of osteonecrosis of the jaw (ONJ), which can cause jaw pain 4, 5, 6, 3.
• ONJ is a rare but potentially serious adverse event associated with antiresorptive therapy, including bisphosphonates and denosumab 4, 5, 6, 7.
• The risk of ONJ is higher in patients receiving denosumab therapy compared to bisphosphonates, with a rate ratio of 6.3 (95% CI 2.1 to 22.8) 7.
• Previous bisphosphonate therapy before switching to denosumab may be an additional risk factor for ONJ development 7.

Jaw Pain and Osteonecrosis of the Jaw

• Jaw pain can be a symptom of ONJ, which is characterized by necrotic bone exposure and can be triggered by dental extraction or other local factors 5, 6, 3.
• The clinical characteristics of ONJ include symptoms such as jaw pain, swelling, and discharge, as well as radiographic findings such as sclerosis of the bone 5, 3.
• Treatment of ONJ typically involves conservative measures such as antibiotics and chlorhexidine mouthrinse, as well as surgical debridement and sequestrectomy in more severe cases 5, 3.