Published: 5 March 2026
Publications
Recent data sheet updates: Important new safety information
Published: 5 March 2026
Prescriber Update 47(1): 18–19
March 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) | Sectiona | Summary of new safety information |
| Alfentanil Alfentanil (Medsurge) |
4.4 | Opioid class effects: Sleep-related breathing disorders; Adrenal insufficiency; Endocrine effects; Hepatobiliary disorders; Gastrointestinal toxicity |
| 4.8 | Opioid class effects: Central sleep apnoea syndrome; Pancreatitis; Spasm of sphincter of Oddi; Adrenal insufficiency and Androgen deficiency | |
| 4.9 | Toxic leukoencephalopathy has been observed with opioid overdose. | |
| Amoxicillin + clavulanic acid Augmentin |
4.4, 4.8 | Haemophagocytic lymphohistiocytosis (HLH)/Macrophage activation syndrome (MAS) |
| Azathioprine Azamun |
4.4 | Posterior reversible encephalopathy syndrome (PRES) |
| 4.8 | PRES; Pellagra; Tremor; Sialadenitis | |
| Bacillus Calmette-Guérin (BCG) OncoTICE |
4.8 | HLH |
| Dabrafenib Tafinlar |
4.8 | When used in combination with trametinib: Tattoo-associated skin reaction |
| Dexamethasone DBL Dexamethasone Sodium Phosphate |
4.4. 4.5 | Musculoskeletal disorders: Acute myopathy has been reported with high doses, in patients with neuromuscular transmission disorders or with concomitant use of anticholinergics, such as neuromuscular blocking agents (eg, pancuronium bromide). |
| Dulaglutide Trulicity |
4.4 | Psychiatric disorders: Suicidal behaviour and ideation have been reported with GLP-1 receptor agonists. |
| Enalapril Acetec |
4.4 | Neutropenia/agranulocytosis |
| 4.8 | Psoriasis/psoriasis aggravated | |
| Flucloxacillin Flucil |
4.8 | Aseptic meningitis; Hyperkinesia |
| Gadobutrol Gadovist 1.0 |
4.4 | Acute respiratory distress syndrome (ARDS) |
| Hydroxychloroquine Plaquenil |
4.4 | Haemolytic anaemia associated with glucose-6-phosphate dehydrogenase (G6PD) deficiency |
| Ibrutinib Imbruvica |
4.8 | Uveitis |
| Isotretinoin Oratane |
4.4 | Sexual disorders have been reported in patients treated with isotretinoin. In some cases, symptoms have persisted after discontinuation. Psychiatric disorders (updated): Reports of persistent symptoms after discontinuation; Assess mental health before treatment; Discontinue treatment if symptoms of depression develop or worsen. |
| 4.8 | Anhedonia; Gynaecomastia | |
| Leflunomide Arava |
4.4 | Skin reactions: HLH, including MAS |
| 4.8 | Pulmonary nodule | |
| Medroxyprogesterone acetateb Depo-Provera Proverac |
4.4 | Meningioma (updated): Monitor patients for signs and symptoms; If used for a non-oncological indication and meningioma develops, discontinue use; If used for an oncological indication and meningioma develops, carefully consider the ongoing need for treatment. |
| Meropenem Meropenem-AFT |
4.4, 4.8 | Drug-induced liver injury |
| 4.8 | Hypokalaemia | |
| Mesalazine Pentasa |
4.4, 4.8 | Idiopathic intracranial hypertension (pseudotumor cerebri) |
| 4.4 | Discontinue use immediately if renal function deteriorates. | |
| Tamoxifen Tamoxifen Sandoz |
4.4 | Premenopausal women (updated): May reduce bone mineral density – provide advice about measures to maintain bone health. |
| Testosterone Reandron 1000 Sustanon |
4.4, 4.8 | Pulmonary oil microembolism |
| 4.5 | Interaction with insulin and other anti-diabetic medicines, including sodium-glucose co-transporter 2 (SGLT-2) inhibitors | |
| Trametinib Mekinist |
4.8 | When used in combination with dabrafenib: Tattoo-associated skin reaction |
| Warfarin Marevan |
4.8 | Tracheal or tracheobronchial calcification |
| Zopiclone Imovane Zopiclone Actavis |
4.4, 4.9 | Haemolysis/haemolytic anaemia have been reported in cases of overdose |
- Data sheet sections listed in the table are: 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.
- See also the March 2025 article: Medroxyprogesterone acetate and meningioma.
- For Provera, the meningioma warning applies to ≥100mg dose tablets.
