Sharing information to enhance patient safety

EVENT: Medication adverse

drug reaction
INJ URY: Osteonecrosis of jaw
January 2014 Issue 62
Treatment injury case study
Case study: Bisphosphonate related osteonecrosis of jaw (BRONJ)
Case Study
65-year-old John, a plumber, suffered osteonecrosis of his lower right jaw secondary to using
bisphosphonate alendronate (Fosamax).
John was otherwise healthy with no long-term health
conditions, but had had a fall three years earlier and been
diagnosed as at risk of osteoporosis. He was prescribed
Fosamax, which he used for three years for the treatment
of osteoporosis to prevent any fracture injuries. John then
presented to a dentist with a complaint of pain in his lower
right jaw. His dental records demonstrated that he had a
dental history of a loose bridge in the lower right side of
the jaw and an abscess at tooth 48 with pain around the
tooth 45 region. John had both teeth extracted but still
complained of ongoing pain and swelling in the mandible,
and was referred to a periodontist.
John was also seen by an otorhinolaryngologist (ENT
specialist) for ongoing pain in the jaw and ear. High doses
of pain relief medication were prescribed, but the pain
and swelling continued. Finally he was seen by an oral
surgeon for his ongoing pain and swelling related to the
anterior mandible. The surgeon expressed initial concern
of osteonecrosis of the jaw and ordered a computerised
tomography (CT) scan of the jaw. The CT scan findings
were consistent with osteonecrosis of the right lower
jaw. Fosamax was thought to be the likely cause of the
osteonecrosis. Fosamax was stopped and a treatment
injury claim was lodged with ACC by the oral surgeon for
the adverse drug reaction caused by the long-term use of
Fosamax.
ACC sought external clinical advice in clinical
pharmacology and accepted the claim as the osteonecrosis
of the right lower jaw had been caused by the use of
Fosamax medication. It is a known but rare complication
of Fosamax treatment. ACC was able to assist in covering
the costs of reconstruction surgery, dental treatment and
loss of income during the procedures.
Expert commentary
Dr John Edwards, Oral & Maxillofacial Surgeon ,
ONZM,BDS,FDSRCS (Eng), FRACDS
Osteonecrosis of the jaw associated with radiotherapy,
infection and some medications has been known for
many years. Recently (since 2003) a specific form of
osteonecrosis associated with bisphosphonates has been
recognised. Bisphosphonate-related osteonecrosis of the
jaw (BRONJ) has been defined as an area of exposed bone
in the mouth present for at least eight weeks in a patient
with current or previous treatment with bisphosphonates,
and no history of radiation therapy to the jaw.
Key points
Bisphosphonate-related osteonecrosis of the
jaw (BRONJ) has been defined as an area
of exposed bone in the mouth present for at
least eight weeks in a patient with current or
previous treatment with bisphosphonates
Where bisphosphonates are used in high
doses intravenously for the management of
complications of malignancy, the risk of the
development of BRONJ is in the range of 4-40%
For patients with osteoporosis on oral
bisphosphonates (alendronate), the risk of
developing BRONJ following dental extractions
is low, ranging from 1 in 225 to 1 in 200,000
Discontinuing oral bisphosphonates prior to a
surgical dental procedure is of doubtful benefit
because of the long half-life of the drug. If
systemic conditions permit, patients who have
been on bisphosphonates for a short period of
time may benefit from cessation of the drug
Patients on bisphosphonates should maintain
optimal oral health. Those undergoing IV
bisphosphonate therapy should undergo
dental assessments and treatment before
commencing therapy.
Case study
About this case study
This case study is based on information amalgamated from a number
of claims. The name given to the patient is therefore not a real one.
The case studies are produced by ACCs Treatment
Injury Centre, to provide health professionals with:
an overview of the factors leading to treatment injury
expert commentary on how similar injuries might be avoided in
the future.
The case studies are not intended as a guide to treatment injury cover.
Send your feedback to: TI.info@acc.co.nz
Because of its recent recognition, its relative rarity and
the possibility of spontaneous development, the true
incidence of BRONJ has yet to be established. Where
bisphosphonates are used in high doses intravenously
for the management of complications of malignancy,
the risk of the development of BRONJ is in the range of
4-40%. An annual dose of IV zoledronate to manage post-
menopausal osteoporosis does not confer an increased risk
of BRONJ.
For patients with osteoporosis on oral bisphosphonates
(alendronate), the risk of developing BRONJ following
dental extractions is low, ranging from 1 in 225 to 1 in
200,000. Pharmac estimates that 66,400 patients in
2011 were taking alendronate. There may be a currently
unidentifiable subset of patients who are at particular
risk, but known risk factors are the elderly, immuno-
suppression, obesity, significant periodontal disease and
oral infections and the total cumulative dose of the drug.
No reliable predictive tests have been developed. The
cause of the disease has still not been established, but it
is usually initiated by trauma to the jawbone, particularly
dental extractions, or trauma from a denture.
As in Johns case, pain, swelling and discharge are the
usual presenting symptoms, and examination shows in
the early stages loose teeth or a discharging sinus, with
a mucosal ulcer and exposed bone in the later stages.
Radiographic findings of BRONJ are not specific and
are found in other conditions such as osteomyelitis and
osteoradionecrosis.
There are no evidence-based guidelines for the
management of BRONJ and treatment protocols are
constantly evolving.
Appropriate analgesics and antibiotics should be
prescribed and the patient referred to their dentist
or oral and maxillofacial surgeon for assessment and
management. In the early stages of the disease, the
management of exposed bone is conservative, with a
radical removal of bone and reconstruction preserved for
severe disease.
Guidelines
1. Patients undergoing IV bisphosphonate therapy for
complications of malignant disease presenting with
symptoms of pain and swelling should be referred and
managed in a public hospital.
2. Patients on oral alendronate presenting with pain and
swelling persisting following a dental extraction, or
suddenly developing loose teeth, should be referred
to their dentist or oral and maxillofacial surgeon for
assessment and management.
3. Discontinuing oral bisphosphonates prior to a surgical
dental procedure is of doubtful benefit because of the
long half-life of the drug. If systemic conditions permit,
patients who have been on bisphosphonates for a short
period of time may benefit from cessation of the drug.
4. Patients on bisphosphonates should maintain optimal
oral health. Those undergoing IV bisphosphonate
therapy should undergo dental assessments and
treatment before commencing therapy.
5. All patients commencing bisphosphonate therapy
should have an explanation of the risks of developing
BRONJ.
6. In order to improve our understanding of this
problematic condition, all cases of BRONJ should
be referred to the Intensive Medicines Monitoring
Programme.
References
1. Ruggiero S L, Dodson T B, Assael L A, Landesberg R, Marx R E, Mehrotra B.
American Association of Oral & Maxillofacial Surgeons position paper on
bisphosphonate related osteonecrosis of the jaws 2009 Update J Oral Maxillofac
Surg 67.2 2009(suppl 1)
2. Cheng A, Hutcheson A, Sambrook P, Goss A. The frequency of bisphosphonate
related osteonecrosis of the jaws (BRONJ): A single centre prospective,
International Journal OMS 2013; 1410, 1185
3. Gray J, Oral health care for people taking bisphosphonates NZDA News 166
December 2013
Claims information
Between July 2005 and December 2013, ACC received 4461 treatment injury claims
related to adverse drug reactions to prescribed medication. Of these, 3983 (89%)
claims were accepted. Approximately 31 claims were related to bisphosphonate usage
causing treatment injuries; of these, 19 claims were accepted and 12 were declined.
The most common reasons for declining claims related to treatment with
bisphosphonate were that no physical injury could be identified and there was no
causal linkage between the injury claimed and the usage of bisphosphonate.
How ACC can help your patients following treatment injury
Many patients may not require assistance following their treatment injury.
However, for those who need help and have an accepted ACC claim, a
range of assistance is available, depending on the specific nature of the
injury and the persons circumstances. Help may include things like:
contributions towards treatment costs
weekly compensation for lost income (if theres an inability to
work because of the injury)
help at home, with things like housekeeping and childcare.
No help can be given until a claim is accepted, so its important to
lodge a claim for a treatment injury as soon as possible after the
incident, with relevant clinical information attached. This will ensure
ACC is able to investigate, make a decision and, if covered, help your
patient with their recovery.
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