Denosumab (Prolia, Xgeva▼): Risk of osteonecrosis of jaw and external auditory canal

Access to the full content of this site is available only to registered healthcare professionals. Register to read more

Denosumab is a human monoclonal IgG2 antibody. Denosumab (Prolia▼) 60 mg solution for injection is indicated for for the treatment of osteoporosis in postmenopausal women and for the treatment of bone loss associated with hormone ablation and prostate cancer for men at increased fracture risk. Denosumab (Xgeva▼) 120 mg solution for injection is indicated for the prevention of skeletal-related events like pathological fracture, radiation to bone, spinal cord compression, or surgery to bone in adults with bone metastases from solid tumours, and for the treatment of adults with giant cell tumour of bone that is unresectable or where surgical resection is likely to result in severe morbidity.

Five cases of osteonecrosis of the external auditory canal have been reported with use 60 mg denosumab. Th...

Recommended for you

  • Drug Updates
  • 1 comment

Misoprostol vaginal delivery system (Mysodelle): reports of excessive uterine contractions

  • Drug Updates
  • 1 comment

Use of gadolinium-containing contrast agents like gadodiamide (Omniscan) and intravenous gadopentetic acid (Magnevist) suspended

  • Drug Updates
  • 1 comment

Incidence of death and fractures reported with concomitant use of radium-223 dichloride (Xofigo▼) and abiraterone, prednisone/prednisolone

  • Drug Updates
  • 1 comment

Eluxadoline (Truberzi▼): Risk of pancreatitis and contraindication in patients who have undergone cholecystectomy or with biliary disorders

  • Drug Updates
  • 1 comment

Fingolimod (Gilenya▼): Risk of serious cardiac arrhythmias

  • Drug Updates
  • 1 comment

Fingolimod (Gilenya▼): Risk of skin cancer, lymphoma and serious opportunistic infections

  • Drug Updates
  • 1 comment

Reports of progressive multifocal encephalopathy (PML) post-treatment with Cladribine (Litak, Leustat) for leukaemia

  • Drug Updates
  • 1 comment

Inadvertent switching between brands of tacrolimus associated with reports of toxicity and graft rejection

  • Drug Updates
  • 1 comment

Quinine: Dose-dependent effects on QT interval and drug interactions

  • Drug Updates
  • 1 comment

Reports of some batches of gentamicin sulphate active pharmaceutical ingredient containing higher than expected histamine levels

  • Drug Updates
  • 1 comment

Patient-related factors and 3 risk-based categories should be considered while prescribing antiepileptic drugs

  • Drug Updates
  • 1 comment

Gabapentin (Neurontin): Risk of developing respiratory depression without concomitant use of opioids

  • Drug Updates
  • 1 comment

Do not use Solu-Medrone 40 mg in patients with a known or suspected allergy to cows’ milk

  • Drug Updates
  • 1 comment

Clozapine associated with risk of intestinal obstruction, faecal impaction, and paralytic ileus

  • Drug Updates
  • no comment

Isotretinoin (Roaccutane): Risk of sexual side effects like erectile dysfunction and decreased libido

  • Drug Updates
  • 1 comment

Loperamide (Imodium): Overdoses of loperamide associated with risk of serious cardiovascular events

  • Drug Updates
  • 1 comment

Patients on warfarin should not use over-the-counter Miconazole oral gel (Daktarin)

  • Drug Updates
  • 1 comment

Revised recommendations for use of adrenaline auto-injectors post European review

  • Drug Updates
  • 1 comment

Local and systemic administration of corticosteroids: risk of central serous chorioretinopathy

  • Drug Updates
  • no comment

Ibrutinib (Imbruvica▼): Reported cases of ventricular tachyarrhythmia and risk of hepatitis B reactivation and opportunistic infections

  • Drug Updates
  • 1 comment

Daclizumab (Zinbryta▼) in multiple sclerosis: Review patients for liver function currently on treatment

  • Drug Updates
  • 1 comment

Nivolumab (Opdivo▼), pembrolizumab (Keytruda▼): Risk of graft rejection

  • Drug Updates
  • 1 comment

Bendamustine (Levact): Increased mortality when used in combination treatment outside the approved indications

  • Drug Updates
  • 1 comment

Brimonidine gel (Mirvaso): Risk of cardiovascular events if applied to damaged skin

  • Drug Updates
  • 1 comment

Yellow Card Scheme Website: Report any side effects or safety concerns with e-cigarettes and e-liquids

  • Drug Updates
  • no comment

Restrictions to manage the risk for misuse of pseudoephedrine and ephedrine to be continued

  • Drug Updates
  • 1 comment

Denosumab (Prolia, Xgeva▼): Risk of osteonecrosis of jaw and external auditory canal

  • Drug Updates
  • no comment

Finasteride 1 mg (Propecia): Reports of depression and suicidal thoughts in men

  • Drug Updates
  • 1 comment

Valproate (Epilim▼, Depakote▼): High risk of neurodevelopmental disability and birth defects

  • Drug Updates
  • 1 comment

Multiple sclerosis: Rebound syndrome after stopping fingolimod (Gilenya▼) or switching therapy