Published: 4 September 2025
Publications
Recent data sheet updates: important new safety information
Published: 4 September 2025
Prescriber Update 46(3): 53–54
September 2025
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 |
|
Acalabrutinib Calquence |
4.2 | Dose adjustments: management of adverse reactions in patients receiving Calquence in combination with bendamustine and rituximab for patients with previously untreated mantle cell lymphoma (MCL) |
| 4.8 | Safety data in patients with previously untreated MCL | |
|
Adrenaline EpiPen EpiPen Jr |
4.4 | Biphasic anaphylaxis – recurrence of symptoms following initial resolution |
|
Alprostadil Prostin VR |
4.4 | Contains ethanol as an excipient, which may cause central nervous system depressant effects, such as somnolence, and may alter the effects of other medicines |
|
Amitriptyline Arrow-Amitriptyline |
4.4, 4.8 | Severe cutaneous adverse reactions (SCARs) including drug reaction with eosinophilia and systemic symptoms (DRESS) |
|
Apixaban Eliquis |
4.8 | Cutaneous vasculitis |
|
Diltiazem Cardizem CD |
4.8 | Lupus-like syndrome |
|
Durvalumab Imfinzi |
4.4 | In combination with olaparib: warnings for pure red cell aplasia and autoimmune haemolytic anaemia |
|
Elexacaftor + tezacaftor + ivacaftor Trikafta |
4.2, 4.5 | No dose adjustment required with concomitant use of ciprofloxacin |
| 4.4, 4.8 | Liver failure leading to transplantation in patients with and without pre-existing advanced liver disease; Updated monitoring recommendations for serum transaminases and total bilirubin; Added clinical signs of liver injury | |
|
Empagliflozin Jardiance |
4.4 | Ketoacidosis and glycosuria may last longer than expected after stopping Jardiance; Necrotising fasciitis reported in patients treated with empagliflozin for all indications |
| 4.8 | Phimosis reported with genital infection | |
|
Gadolinium-based contrast agents Gadovist Primovist |
4.6 | Pregnancy: information from the literature regarding exposure during pregnancy and fetal outcomes |
|
Lamotrigine Lamictal |
4.4 | Skin rash: Human leukocyte antigen (HLA)-B*1502 allele associated with risk of developing Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) |
| 4.8 | Photosensitivity reaction | |
|
Lenvatinib Lenvima |
4.4, 4.8 | Tumour lysis syndrome |
|
Losartan + hydrochlorothiazide Arrow-Losartan potassium & Hydrochlorothiazide |
4.4, 4.8 | Intestinal angioedema |
|
Lidocaine + prilocaine Numit |
4.2 | Increased risk of serious adverse reactions (eg, methaemoglobinaemia) if recommended dose or duration of treatment exceeded especially in children aged below 3 months. |
|
Mesalazine Asacol |
4.4, 4.8 | Idiopathic intracranial hypertension (pseudotumor cerebri) |
|
Metronidazole Flagyl, Flagyl-S |
4.4, 4.8 | Drug reaction with eosinophilia and systemic symptoms (DRESS) |
|
Olaparib Lynparza |
4.4, 4.8 | Drug-induced liver injury (DILI) |
|
Paracetamol + codeine + doxylamine succinate Mersyndol |
4.4, 4.5 | Concomitant use with gabapentinoids is not recommended due to the risk of additive CNS depressant effects (eg, respiratory depression, hypotension, sedation, coma, death) |
|
Propofol Diprivan |
4.5 | Interactions with alfentanil, dexmedetomidine, sevoflurane, midazolam |
|
Rifampicin + isoniazid Rifinah |
4.6 | Fertility: Rifampicin has a genotoxic potential in animals, which is a risk factor for impairment of human fertility |
|
Salbutamol Ventolin |
4.4, 6.6 | The inhaler does not have a dose counter. It contains enough salbutamol for 200 actuations (puffs) only. After 200 actuations, the inhaler can continue to spray but without the prescribed dose of salbutamol. Consider keeping a record of the number of doses administered and/or a back-up inhaler |
|
Sunitinib Sunitinib Pfizer Sutent |
4.4, 48 | Hyperammonaemic encephalopathy |
|
Tobramycin Tobra-Day |
4.4 | Severe cutaneous adverse reactions (SCARs) |
|
Tramadol Tramal |
4.5 | Concomitant use with anticholinergics may result in increased anticholinergic adverse effects |
| 4.9 | Death can occur following overdose | |
|
Upadacitinib Rinvoq |
4.4 | Medication residue in stool |
|
Varicella zoster (shingles) vaccine Shingrix |
4.4, 4.8 | Guillain-Barré syndrome |
| 4.5 | Shingrix may be given concomitantly with respiratory syncytial virus (RSV) vaccine (recombinant, adjuvanted) | |
|
Zuclopenthixol Clopixol |
4.4, 4.8 | Dysphagia can occur secondary to extrapyramidal symptoms, sialorrhea, sedation and neuroleptic malignant syndrome |
* Data sheet sections listed in the table are: 4.2: Dose and method of administration; 4.4: Special warnings and precautions for use; 4.5: Interaction with other medicines and other forms of interaction; 4.6: Fertility, pregnancy and lactation; 4.8: Undesirable effects; 4.9: Overdose; 6.6 Special precautions for disposal
