Osteonecrosis of the Jaw (ONJ): Label Warnings | Dose Track
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Osteonecrosis of the jaw

Also called ONJ, jaw bone death, jaw osteonecrosis · Reviewed

Definition: Osteonecrosis of the jaw (ONJ) is death of bone tissue in the jaw. It is a listed warning on bisphosphonate labels such as Fosamax and Reclast and on the Prolia (denosumab) label. Reported cases are usually linked to a tooth extraction or a local infection that heals slowly.

What the labels say

The Fosamax label (section 5.4) says jaw bone death has been reported, usually with tooth extraction or local infection with slow healing. It lists these risk factors:

  • invasive dental work, such as an extraction;
  • cancer and chemotherapy;
  • steroid medicines;
  • poor mouth care and gum disease.

The Fosamax label adds that the risk may grow with longer use. The Prolia label also lists jaw bone death, usually linked to tooth extraction or infection with slow healing.

Why it matters for your log

Because dental work is the main trigger named, the date of your last dose and how long you have been on the drug are useful to a dentist. A clear record of every weekly tablet, yearly infusion or six-month shot answers both questions. Labels set the length of use with the prescriber, not the dentist, so changes to the plan go through them.

What it is not

ONJ is different from the unusual thigh fractures on the same labels, though both are tied to long-term use of bone drugs. Both are listed as warnings, not as common side effects in the trial tables.

Read more on Dose Track: Fosamax side effects · Prolia side effects · Reclast side effects

General education drawn from labels and published studies, not personal medical advice. Your prescriber, pharmacist and the label that came with your product are the final word.
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Frequently asked questions

What triggers osteonecrosis of the jaw?+
The Fosamax label says reported cases were usually linked to a tooth extraction or a local infection with slow healing.
Should I tell my dentist I take a bisphosphonate?+
Invasive dental work is a listed risk factor, so the drug, how long you have taken it and your last dose are useful for your dentist and prescriber to know.

Sources

  1. Fosamax (alendronate) US prescribing information, DailyMed
  2. Prolia (denosumab) US prescribing information, DailyMed
  3. Reclast (zoledronic acid) US prescribing information, DailyMed

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