Published: 4 June 2026
Publications
Recent data sheet updates: Important new safety information
Published: 4 June 2026
Prescriber Update 47(2): 34–35
June 2026
Table 1 below provides a list of data sheets recently updated with important new safety information. Note that this is not a comprehensive list of all recently updated data sheets, nor does it describe all changes to a particular data sheet.
To find out if sponsors have made any changes to their data sheets, refer to:
- section 10 ‘Date of revision of the text’ (at the end of each data sheet). Search for a data sheet
- the New/updates to data sheets and CMIs page on the Medsafe website.
Table 1: Recently updated data sheets (by active ingredient): important new safety information
Click on the specific medicine to open the data sheet.
| Active ingredient(s): | Data sheet updates | |
|---|---|---|
| Medicine(s) | Section* | Summary of new safety information |
| Apalutamide Erlyand |
4.5 | Laboratory test interference – Falsely elevated digoxin plasma level results with the chemiluminescent microparticle immunoassay (CMIA) have been identified in patients treated with apalutamide, independently of being treated with digoxin. |
| Carbamazepine Tegretol |
4.2, 4.4 | Maximum daily dose of the oral syrup is limited to 1,200
mg. At total daily doses over 1,200 mg, there is the possibility of exceeding internationally accepted daily exposure limits for trace substances in the sorbitol excipient. |
| 4.8 | Fixed drug eruption; Generalised bullous fixed drug eruption | |
| Colchicine Colgout |
4.4, 4.5 | Co-administration with P-gp inhibitors and/or moderate or strong CYP3A4 inhibitors will increase the exposure to colchicine, which may lead to colchicine induced toxicity including fatalities. In patients with normal renal and hepatic function (contraindicated in patients with renal or hepatic impairment), reduce the colchicine dose and monitor for adverse effects, or interrupt colchicine treatment. |
| Cytarabine Cytarabine DBL Cytarabine |
4.8 | Toxic erythema of chemotherapy, including hidradenitis, palmar-plantar erythrodysaesthesia syndrome, red ear syndrome |
| Dexamfetamine Dexamfetamine (Noumed) |
4.5, 4.9 | Serotonin syndrome can occur with concurrent use of serotonergic medicines, and in overdose. |
| 4.8 | Constipation; Raynaud’s phenomenon | |
| Disulfiram Antabuse |
4.8 | Depression; Libido decreased; Psychotic reaction; Optic neuritis; Encephalopathy; Nausea; Vomiting; Dermatitis allergic; Fatigue |
| Doxorubicin Caelyx |
4.8 | Renal-limited thrombotic microangiopathy has been reported in patients with high cumulative exposure to pegylated liposomal doxorubicin. |
| IncobotulinumtoxinA Xeomin |
4.4, 4.8, 4.9 | Toxin spread – Cases of iatrogenic botulism have been reported following injection of botulinum toxin products. Advise patients and caregivers to seek immediate medical care if they experience signs or symptoms consistent with spread of botulinum toxin effect. |
| Infliximab Remicade |
4.4 | Contains Polysorbate 80 which may cause allergic reactions. |
| 4.8 | Rheumatoid arthritis and inflammatory bowel disease as additional examples of new onset paradoxical drug-induced immune disorders. | |
| Leflunomide Arava |
4.4 | Musculoskeletal disorders – Myopathy and/or muscle injury has been reported. Monitor patients for signs and symptoms. |
| Lisdexamfetamine Vyvanse |
4.8 | Obsessive compulsive disorder (including trichotillomania and dermatillomania |
| 4.8, 4.9 | Takotsubo cardiomyopathy (stress cardiomyopathy) | |
| Metronidazole Rozex Cream Rozex Gel |
4.3 | Contraindicated in patients with Cockayne syndrome. |
| Paracetamol + Codeine + Doxylamine Mersyndol |
4.4 | QT interval prolongation – Doxylamine may potentiate QT interval prolongation. |
| Prednisone Prednisone (Clinect) |
4.4 | Thyrotoxic periodic paralysis (TPP) can occur in patients with hyperthyroidism and with prednisone-induced hypokalaemia. Suspect TPP if patients present with muscle weakness; monitor blood potassium and ensure it returns to normal levels. |
| Rocuronium Rocuronium bromide (Medsurge) |
4.4 | Hypertensive crisis in patients with phaeochromocytoma. Use rocuronium with caution in these patients. |
| 4.8 | Anaphylaxis – hypersensitivity | |
| Tolvaptan Jinarc |
4.8 | Blood creatinine phosphokinase increased |
| Upadacitinib Rinvoq |
4.8 | Semen discolouration (blue or green) has been reported in patients with ulcerative colitis or Crohn’s disease taking the 45mg Rinvoq induction dose. There were no clinically meaningful adverse events reported with the semen discolouration. |
| Vortioxetine Brintellix |
4.2 | Treatment discontinuation – Gradually reduce the dose to avoid discontinuation symptoms. |
| 4.8 | Discontinuation symptoms/discontinuation syndrome – May occur within the first week of vortioxetine discontinuation. Symptoms include dizziness, headache, sensory disturbances, sleep disturbances, nausea and/or vomiting, anxiety, irritability, agitation, fatigue and tremor. | |
* Data sheet sections listed in the table are: 4.2: Dose and method of administration; 4.3: Contraindications; 4.4: Special warnings and precautions for use; 4.5: Interaction with other medicines and other forms of interaction; 4.8: Undesirable effects; 4.9: Overdose
