Published: 20 October 2014
Revised: 22 May 2015
Safety Information
Early Warning System - Monitoring Communication
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
- treatment of osteoporosis in postmenopausal women to reduce the incidence of hip, vertebral and non-vertebral fractures and to increase bone mineral density
- treatment of osteoporosis in men
- treatment of Paget's disease of bone
- treatment and prevention of glucocorticoid-induced osteoporosis
- prevention of clinical fractures in patients after hip fracture and prevention of postmenopausal osteoporosis
Zometa is indicated for
- prevention of skeletal-related events (pathological fracture, spinal cord compression, radiation to bone or surgery to bone) in patients with advanced malignancies involving bone
- treatment of tumour-induced hypercalcaemia
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 ()
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
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.
