Published: 5 June 2025
Publications
Recent data sheet updates: important new safety information
Published: 5 June 2025
Prescriber Update 46(2): 34–35
June 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): Medicine(s) | Data sheet updates | |
|---|---|---|
| Sectiona | Summary of new safety information | |
| Adalimumab Humira |
4.8 | Autoimmune hepatitis |
| Dorzolamide + Timolol Dortimopt |
4.8 | Atrioventricular block; Cardiac failure; Tachycardia; Hypertension; Dysgeusia |
| Dulaglutideb Trulicity |
4.4 | Severe gastrointestinal disease: advise patients of the risk of dehydration and take precautions to avoid fluid depletion |
| Flucloxacillin Staphlex |
4.5 | Interaction with voriconazole |
| Liraglutideb Saxenda Victoza |
4.4 | Risk of pulmonary aspiration in association with general anaesthesia or deep sedation due to delayed gastric emptying |
| Losartan Losartan Actavis |
4.4, 4.8 | Intestinal angioedema |
| Macrogol + electrolytes Plenvu |
4.4, 4.8 | Seizures; Oesophageal rupture (Boerhaave syndrome) |
| Metronidazole Flagyl |
4.3 | Cockayne syndrome |
| 4.4 | Posterior reversible encephalopathy syndrome (PRES); Inflammatory bowel disease (IBD) | |
| 4.8 | PRES; Severe irreversible hepatoxicity/acute liver failure in patients with Cockayne syndrome | |
| Neisseria meningitidis Group A, C,
W135, Y polysaccharide MenQuadfi |
4.2 | May be given as a single booster dose to individuals who have previously been primed with meningococcal vaccine at least 3 years prior (changed from 4 years) |
| 4.5 | May be given concomitantly with meningococcal B (MenB) vaccine | |
| 4.8 | Increased rate and intensity of systemic adverse reactions with concomitant MenB (clinical study in those aged 13–26 years) | |
| Normal immunoglobulin Privigen Privigen NZ |
4.4 | Aseptic meningitis syndrome (AMS): new information about AMS symptoms and examination; monitor patients with recurrent AMS for the emergence or worsening of symptoms that may indicate progression to brain/cerebral oedema. |
| Oxaliplatin Oxaliplatin Accord Oxaliplatin (Alchemy) |
4.6 | Use effective contraception before starting and during treatment, and for at least 9 months after the last dose for female patients of childbearing potential and for at least 6 months after the last dose for male patients with female partners of childbearing potential; Potential adverse effects on male fertility; Breastfeeding is contraindicated during treatment and for 3 months after the last dose. |
| Oxycodone Oxycodone Sandoz |
4.4 | Hepatobiliary disorders (pancreatitis and diseases of the biliary tract) |
| 4.5 | Interactions with selective serotonin re-uptake inhibitors (SSRI) or serotonin norepinephrine re-uptake inhibitors (SNRI) | |
| Risedronate Risedronate Sandoz |
4.4 | Bisphosphates may cause hypocalcaemia and/or hypophosphatemia due to effects on bone. Monitoring of calcium and phosphate may be needed throughout treatment, especially in individuals with risk factors. |
| Rivaroxaban Xarelto |
4.8 | Splenic rupture (secondary to severe bleeding) |
| Tamoxifen Tamoxifen Sandoz |
4.4 | QTc interval prolongation in patients with underlying risks and cardiac morbidities |
| Tigecycline Tygacil |
4.8 | Fixed drug eruption |
| Zoledronic acidc Aclasta |
4.4 | Bisphosphates may cause hypocalcaemia and/or hypophosphatemia due to effects on bone. Consider calcium and phosphate post each infusion and monitor for symptoms of hypocalcaemia and hypophosphatemia. |
- 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; 4.6: Fertility, pregnancy and lactation; 4.8: Undesirable effects.
- See also the article on GLP-1 receptor agonists and renal adverse events on page 24.
- See also the Gathering Knowledge article on page 31 for a case of hypophosphataemia following a zoledronic acid infusion.
