Published: 22 November 2022
Safety Information
Monitoring communication
Goserelin (Teva) 3.6mg and 10.8 mg implants and reports of issues when administering this medicine
22 November 2022
Medsafe has received reports of issues associated with the use of Goserelin (Teva) implants. These reports include:
- increased pain and discomfort on insertion and administration of implant
- haematoma / bleeding at administration site
- the device does not fully deploy/retract despite following the manufacturer’s instructions
- the implant, or part of the implant, remains in the rod after administration.
Medsafe is investigating these reports and is seeking information from users of Goserelin (Teva) to assist the investigation. Please report issues associated with administration of this medicine to: recalls@health.govt.nz
Product affected
Additional information
Regulator actions
Reporting
Product affected
| Product name | Sponsor |
|---|---|
| Goserelin (Teva) | Teva Pharma (New Zealand) Limited |
Goserelin (Teva) is a subcutaneous implant, containing 3.6mg or 10.8 mg of goserelin (as goserelin acetate) in a prefilled syringe. It is approved for the following indications.
- Prostate cancer suitable for hormone manipulation.
- Adjuvant and neoadjuvant therapy in combination with radiotherapy or the management of locally advanced prostate cancer in men suitable for hormone manipulation.
- Endometriosis: Alleviates symptoms including pain and reduces the size and number of endometrial lesions.
- Uterine fibroids: Shrinks the lesions, reduces symptoms including pain, and causes cessation of menses in the majority of patients thereby improving haematological status when previous heavy menstrual loss has caused anaemia.
Additional information
Goserelin (Teva) is a prescription-only medicine. The data sheet and consumer medicine information sheet are published on the Medsafe website.
Medsafe has received reports of issues associated with the use of Goserelin (Teva) implants. In some reported instances, it is not clear whether the issue relates to user preference, inadequate information or training in use of the product, or with the product itself.
Information on administering the product is provided on the inside of the product box. Further information, guidance and support can be obtained by contacting the Medical Information Team at Teva Pharma (New Zealand) Ltd on 0800 800 097.
Regulator actions
Medsafe is investigating these reports, is in contact with the New Zealand sponsor and is seeking information from users (see below).
Reporting
Medsafe is seeking information from users of Goserelin (Teva) to assist its investigation. When reporting quality issues experienced with this medicine, please be specific as to whether the issue relates to the implant itself or the delivery device, and the consequences or outcome, if any.
Please report quality issues with this medicine to Medsafe at recalls@health.govt.nz
Consumers and healthcare professionals are encouraged to report suspected adverse reactions to medicines to the Centre for Adverse Reactions Monitoring (CARM)
