Bisphosphonate-associated Osteonecrosis
Around the time that Sedghizadeh et al were conducting and reporting on bisphosphonate-related osteonecrosis of the jaw (BRONJ) [See “Reading Rheum,” p. 20], the American Dental Association Council on Scientific Affairs updated their recommendations for managing patients taking oral bisphosphonates.6-7 They note that the risks of developing BRONJ from oral bisphosphonate therapy remains small compared with the risk associated with IV bisphosphonates, a comparison of approximately 0.04% and 20%, respectively. Management of general dentistry for patients taking oral bisphosphonates should include routine dental examinations and routine dental care. Those patients taking oral bisphosphonates who do not receive regular dental care should and would benefit from a comprehensive oral examination. Patients taking oral bisphosphonates should be informed of the following:
- That they are at a low risk of developing BRONJ of the jaw (estimates of zero to 1 in 2,260 cases);
- The low BRONJ risk may be minimized but not eliminated;
- The optimal approach to lowering BRONJ risk may be via good oral hygiene practices and usual care;
- No validated diagnostic techniques are available to determine who is at increased risk of BRONJ;
- Discontinuing bisphosphonates may not eliminate the risk of BRONJ;
- A dentist should be consulted if there are any oral cavity–related problems that develop while receiving bisphosphonate therapy; and
- Any discussions about whether or not to continue bisphosphonate therapy should be held with the prescribing physician. The risk–benefit ratio of oral bisphosphonate therapy should be evaluated, because the benefit often might outweigh the risk.
The goal in BRONJ prevention is to limit the possibility of extensive involvement. The advisory statement discusses management of periodontal disease, implant placement/maintenance, and other dental-related procedures. It is available at http://jada.ada.org/cgi/reprint/139/12/1674.
Pipeline Update
On January 5, the FDA issued a complete response letter to UCB for their certolizumab pegol (Cimzia) Biological License Application to treat rheumatoid arthritis.16 On February 6, UCB announced that the FDA is requiring additional analysis of their existing data and a new safety update, but no additional clinical or nonclinical studies are needed.17 The planned submission date is now in the second quarter of 2009. Certolizumab pegol is the first pegylated anti–tumor necrosis factor (TNF) agent. It is already FDA approved to treat patients with moderate to severe Crohn’s disease.
Acura and King Pharmaceuticals submitted a New Drug Application (NDA) to the FDA for oxycodone hydrochloride/niacin tablets (Acurox), which was accepted as a priority review.18 The proposed indication is treatment of moderate to severe pain. Acurox utilizes a proprietary Aversion technology designed to deter common methods of misuse and abuse, including: intentional swallowing of excess tablet quantities; dissolving tablets and then injecting them via the intravenous (IV) route; and crushing tablets and then nasally snorting the contents.
