Published: 16 May 2019
Revised: 8 January 2020
Safety Information
Monitoring Communication
Risk of infections with Prolia (denosumab)
8 January 2020
Description
Update information
Original communication
Update Information
During the monitoring period (16 May 2019 to 30 November 2019), the Centre for Adverse Reactions Monitoring (CARM) did not receive any further reports of infections associated with the use of denosumab.
Medsafe will continue to monitor this issue through routine pharmacovigilance. The benefit-risk balance for denosumab remains positive and no further action is required at this time.
Original Communication
Monitoring finishes 30 November 2019.
Medsafe is highlighting a possible risk of infections with the use of Prolia (denosumab). To help Medsafe assess whether any additional action is warranted, Medsafe is encouraging prescribers or patients to report any adverse events related to this medicine, particularly any infections. At this stage Medsafe is still considering the significance of this potential safety signal.
This communication was triggered by a report received by the Centre for Adverse Reactions Monitoring (CARM). The report (CARM ID number 131099) describes a 68-year-old female patient who developed severe pneumonia after receiving denosumab.
Various types of infections have been suggested to be potentially associated with Prolia in the scientific literature. Medsafe is therefore encouraging reports of all types of infections to investigate this risk further.
Additional Information
Denosumab is a biologic RANKL inhibitor used to treat osteoporosis in men and postmenopausal women. Prolia is currently the only approved denosumab product for this indication.
The New Zealand data sheet includes warnings on the risk of skin infections, such as cellulitis [1]. Other infections, such as pneumonia, are not stated in the data sheet.
It has been proposed that RANKL inhibition may have immune modulating effects and this may increase the risk of infections. However, clinical trials and observational studies have not conclusively shown that there is a significant risk of severe infections associated with Prolia.
The overall benefit-risk balance of Prolia remains positive. Advice on the known side effects of Prolia can be found in the consumer medicines information (CMI) and data sheets.
Search for consumer medicine information and medicine data sheets
Products Affected
| Product name | Sponsor |
|---|---|
| Prolia | Amgen New Zealand Ltd |
Reporting
Consumers and health professionals can send reports of suspected adverse reactions to CARM. Please report any cases of infections in patients who have received Prolia. Please include information on the type of infection and its severity.
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.
References
- Amgen (New Zealand) Limited. Prolia (60mg solution for injection), New Zealand Data Sheet (20 December 2018). Available at: www.medsafe.govt.nz/profs/datasheet/p/proliainj.pdf
