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Safety Information

Revised: 22 May 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 Zoledronic acid and possible risk of tendon injury/tendinitis added to the medicines monitoring scheme

20 October 2014

The Centre for Adverse Reactions Monitoring (CARM) has received four reports of zoledronic acid associated with tendon injuries which included tendon rupture, tendinitis and tenosynovitis.

Products Affected

Product name (currently approved) Sponsor
Aclasta 5mg/100mL solution for infusion Novartis New Zealand Ltd
Zometa 4mg/5mL liquid concentrate for solution for infusion Novartis New Zealand Ltd


Zoledronic acid belongs to a class of drug called bisphosphonates which reduce the rate of bone turnover.

Aclasta is indicated for

Zometa is indicated for

Additional Information

Tendinitis is inflammation of a tendon which often develops after degeneration (tendinopathy). Tenosynovitis is tendinitis with inflammation of the tendon sheath lining.

Symptoms include pain (with motion) and tenderness (with palpation).

There is no specific mention of tendinitis in the New Zealand data sheets for zoledronic acid although muscle pain, musculoskeletal stiffness, joint swelling, muscle spasms, shoulder pain, musculoskeletal chest pain, musculoskeletal pain, joint stiffness, arthritis and muscular weakness are listed adverse effects in the data sheets.

The benefits of treatment with zoledronic acid continue to outweigh the risks of harm.

Advice on how to take this medicine 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 suspected adverse reactions with zoledronic acid (zoledronate), or other bisphosphonates, in particular tendon injuries including tendon rupture, tendinitis and tenosynovitis.

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

Update to Original Communication

During the M² logo period (1 October 2014 to 30 April 2015), no further cases were reported to the Centre for Adverse Reactions Monitoring (CARM).  The safety concern has been investigated and no link between zoledronic acid and tendon injury was demonstrated.  The balance of benefits and risks of harm for zoledronic acid remains positive and no further action is required at this time.

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

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