Safety Information

Revised: 9 February 2015

Early Warning System - Monitoring Communication

Medsafe emphasises that patients should NOT stop using any medicine or medical device subject to a monitoring communication. If you have any concerns with a medicine or medical device you are using, please contact your health professional. A monitoring communication does not mean that the medicine or medical device causes an adverse event.

M² logo Bisphosphonates and possible risk of optic neuritis added to the medicines monitoring scheme

8 July 2014

The Uppsala Monitoring Centre (UMC), set up by the World Health Organization for international drug monitoring, identified a signal of optic neuritis with the use of pamidronic acid. The UMC has 11 reports of optic neuritis in association with pamidronic acid. One of these reports originated from New Zealand.

There are three literature reports of optic neuritis in association with bisphosphonates1-3. Of the five cases described in these reports, three were with pamidronic acid, one with alendronic acid and one with zoledronic acid.

Products Affected

Bisphosphonates reduce the rate of bone turnover. They are used in the prevention and treatment of osteoporosis and in the treatment of other bone conditions.

Bisphosphonates can also be used for the treatment of tumour-induced hypercalcaemia.  

Product name (currently approved) Sponsor
Alendronic acid (alendronate)  
Fosamax Merck Sharp & Dohme (New Zealand) Limited
Fosamax Plus Merck Sharp & Dohme (New Zealand) Limited
Etidronic acid (etidronate)  
Arrow - Etidronate Actavis New Zealand Limited
Pamidronic acid (pamidronate)  
AFT-Pamidronate AFT Pharmaceuticals Ltd
Pamironate BNM Boucher & Muir (New Zealand) Limited
Pamisol Hospira NZ Ltd
Risedronic acid (risedronate)  
Risedronate Sandoz Novartis New Zealand Ltd
Zoledronic acid (zoledronate)  
Aclasta Novartis New Zealand Ltd
Zometa Novartis New Zealand Ltd

Additional Information

The optic nerve carries information from the eye to the brain to be processed into vision. Optic neuritis is inflammation of the optic nerve which may cause loss of vision usually due to swelling and destruction of the myelin sheath covering the optic nerve.

Symptoms of optic neuritis include loss of vision developing over an hour or a few hours, blurry vision, and pain on movement of the affected eye. It is important that patients seek medical advice as soon as possible.

The New Zealand data sheets for bisphosphonates do not list optic neuritis as an adverse reaction. However, in some of the data sheets other inflammatory ocular reactions are listed such as conjunctivitis, uveitis, scleritis, episcleritis, xanthopsia and orbital inflammation.

The overall benefit-risk balance of bisphosphonates remains positive.

Advice on how to use bisphosphonates and other possible side effects can be found in the consumer medicine information (CMI) and data sheets.

Search for consumer medicine information

Search for data sheet information

Regulator Actions

Medsafe is placing this safety concern on the medicines monitoring (M² logo) scheme to obtain further information on this possible adverse reaction. Please report any adverse events with bisphosphonates, in particular optic neuritis.

Reporting

Consumers and healthcare professionals are encouraged to send reports of suspected adverse reactions to the Centre for Adverse Reactions Monitoring (CARM).

Medsafe cannot give advice about an individual’s medical condition.  If you have any concerns about a medicine you are taking Medsafe encourages you to talk to your healthcare professional.

How to report an adverse reaction

References

  1.  Brulinski P, Nikapota AD.2013. Zolendronic acid-induced retrobulbar optic neuritis: a case report. Clinical Oncology 25: 328–331.
  2.  Stack R, Tarr K. 2006. Drug-induced optic neuritis and uveitis secondary to bisphosphonates. The New Zealand Medical Journal 119.
  3.  Des Grottes JM, Schrooyen M, Dumon JC, et al. 1997. Retrobulbar optic neuritis after pamidronate administration in a patient with a history of cutaneous porphyria. Clinical Rheumatology 16(1): 93–95.

Update to Original Communication

9 February 2015

This safety concern has been investigated through M² logo . No further cases were received. It was concluded that no link between bisphosphonates and optic neuritis was demonstrated. The balance of benefits and risks of harm for bisphosphonates remains positive and no further action is required at this time.

Medsafe will re-investigate this concern should more information become available.