Stopping Bisphosphonates Prior to Oral Surgery
The FDA label states that discontinuation of bisphosphonate treatment may reduce the risk of osteonecrosis of the jaw (ONJ) for patients requiring invasive dental procedures, though the evidence supporting drug holidays remains controversial and clinical judgment should guide individual management. 1
Evidence-Based Risk Stratification
The decision to stop bisphosphonates depends critically on the route of administration and indication:
Oral Bisphosphonates for Osteoporosis (Low Risk)
- The risk of ONJ with oral bisphosphonates is extremely low at <1 case per 100,000 person-years, making routine discontinuation questionable. 2
- The American Society of Clinical Oncology notes that bone effects of bisphosphonates persist for years after stopping, suggesting a short drug holiday may have no protective effect. 3
- For patients on oral bisphosphonates requiring tooth extraction, the risk increases to approximately 1 in 300, which remains relatively low. 4
Intravenous Bisphosphonates for Cancer (High Risk)
- IV bisphosphonates carry a dramatically higher ONJ risk of 6.7-11% in cancer patients, particularly with zoledronic acid and pamidronate. 2
- At least 60% of ONJ cases occur after dentoalveolar surgery, making the timing of dental procedures critical. 3
The Drug Holiday Controversy
There are two opposing viewpoints in the guidelines:
Hypothesis Supporting Drug Holidays:
- Some experts suggest stopping bisphosphonates 2 months prior to oral surgery may allow better bone healing, with resumption delayed until adequate osseous healing occurs. 3, 2
- The FDA label explicitly states that discontinuation may reduce ONJ risk for patients requiring invasive dental procedures. 1
Counterargument Against Drug Holidays:
- The alternative view holds that short breaks have no effect because bisphosphonates' bone effects persist for years after cessation. 3
- Studies show that drug holidays are not significantly effective, likely due to the persistent, long-term pharmacologic activity of bisphosphonates on bone. 5
Practical Clinical Algorithm
For Patients NOT Yet on Bisphosphonates:
- Complete all necessary invasive dental procedures before initiating bisphosphonate therapy whenever possible, as this eliminates ONJ risk entirely. 2, 1
- Perform comprehensive dental evaluation of both hard and soft tissues before starting treatment. 3
- Correct vitamin D deficiency prior to bisphosphonate therapy to avoid hypocalcemia. 2
For Patients Already on Oral Bisphosphonates Requiring Extraction:
- Do not routinely discontinue oral bisphosphonates given the extremely low baseline risk and questionable benefit of drug holidays. 2
- Ensure excellent oral hygiene and provide preoperative antibiotic prophylaxis. 2
- Use atraumatic extraction technique with primary closure and monitor healing closely. 2
- Consider a 2-month drug holiday only for patients with additional risk factors (>3 years of therapy, concurrent corticosteroids, chemotherapy, poor oral hygiene). 6, 4
For Patients on IV Bisphosphonates for Cancer:
- Weigh the tangible risks of interrupting cancer therapy (pathologic fractures, spinal cord compression) against ONJ risk. 2
- If extraction is unavoidable, use prophylactic antibiotics perioperatively and defer resuming bisphosphonates until complete healing is confirmed. 2
- The decision to interrupt therapy must be individualized based on cancer status, bone metastasis burden, and fracture risk. 3
Critical Caveats
Common Pitfall: Confusing the low risk in osteoporosis patients (<1 per 100,000) with the much higher risk in cancer patients receiving high-dose IV bisphosphonates (6.7-11%). 2
Key Risk Factors Beyond Bisphosphonates:
- Recent dental surgery or extraction is the most consistent risk factor for ONJ. 2
- Concurrent chemotherapy, corticosteroids, poor oral hygiene, and pre-existing dental infections all increase risk. 1
- Risk increases with frequency, dose, and duration of bisphosphonate administration. 3, 2
Bottom Line for Real-World Practice
For the typical osteoporosis patient on oral alendronate or risedronate requiring a single tooth extraction, the evidence does not support routine discontinuation. The absolute risk remains extremely low, drug holidays are of unproven benefit, and the fracture prevention benefits of continued therapy generally outweigh the minimal ONJ risk when proper dental protocols are followed. 2, 4
However, for patients with multiple risk factors (>3 years therapy, concurrent steroids, multiple extractions planned), a 2-month drug holiday represents a reasonable precautionary approach, though acknowledge to patients that this strategy lacks definitive evidence. 3, 2, 6
For cancer patients on IV bisphosphonates, the decision requires careful risk-benefit discussion with the oncologist, as interrupting therapy poses real risks of skeletal complications. 3, 2