english.prescrire.org > Spotlight > Archives : 2007 > Bisphosphonates and osteonecrosis of the jaw: insufficient risk warning

Spotlight: Archives

Every month, the subjects in Prescrire’s Spotlight.

2007 : 1 | 30 | 60 | 90

Bisphosphonates and osteonecrosis of the jaw: insufficient risk warning

In autumn 2007, in France, the risk of osteonecrosis of the jaw (bone damage) is not always mentioned in regulatory information on bisphosphonates.

Bisphosphonates are widely used, especially in the treatment of osteoporosis and of some cancer-related bone complications.

The October issue of la revue Prescrire stresses that osteonecrosis (bone damage) of the jaw is a serious adverse effect associated with bisphosphonates. Its frequency increases with the duration of treatment, and it is irreversible. This adverse effect, which can be very painful and incapacitating in terms of eating, appearance and relationships, is sometimes accompanied by ulceration of the tongue and facial nerve damage.

According to a survey, 5% to 11% of cancer patients receiving bisphosphonate treatment have had jaw osteonecrosis, particularly after extended treatment and recent dental surgery, generally with no improvement even after surgery and the cessation of treatment. Cases have also been observed in patients being treated for osteoporosis.

La revue Prescrire deplores the fact that although these adverse effects have been known for several years, some bisphosphonates are still on the market in France without this risk being mentioned in the official information (in particular the information published in the Vidal drug directory). And this despite a European Commission pharmacovigilance notice in 2006 recommending that this risk should be mentioned. The delay in updating this information is not helpful to health professionals or to patients who should be informed of this serious adverse effect.

©Prescrire, 1 November 2007

Source: "Ostéonécroses de mâchoire liées aux diphosphonates" Rev Prescrire 2007; 27 (288): 747-749.

- More articles in Prescrire's "Spotlight"...