Published: 4 December 2025
Publications
Recent data sheet updates: important new safety information
Published: 4 December 2025
Prescriber Update 46(4): 70–71
December 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 |
|
Abemaciclib:
Verzenio |
4.6 | Lactation: Do not breastfeed during treatment or for 3 weeks after the last dose of abemaciclib. |
| 4.8 | Erythema multiforme | |
|
Atezolizumab:
Tecentriq |
4.4 | Other immune-mediated adverse reactions: uveitis |
| 4.8 | Uveitis; Neutropenia; Sarcoidosis; Cytomegalovirus | |
|
Atomoxetine:
Apo-Atomoxetine |
4.4, 4.5, 4.9 | Serotonin syndrome: reported with concomitant use of atomoxetine with other serotonergic medicines. |
| 4.4 | Aggressive behaviour or Hostility or Emotional lability: warning expanded to include severe cases in paediatric patients | |
| 4.8 | Bruxism | |
|
Axitinib:
Inlyta |
4.8 | Pancreatitis |
|
Colchicine:
Colgout |
4.4 | Toxicity and fatal overdose: narrow therapeutic index, keep out of sight and reach of children, counsel patients on when and how to take colchicine. |
| 4.7 | Possible drowsiness and dizziness | |
| 4.8 | Amenorrhoea; Dysmenorrhoea | |
|
Cladribine:
Leustatin |
4.3, 4.6 | Contraindicated during pregnancy and lactation and for 6 months after the last cladribine dose. |
|
Dactinomycin:
Cosmegen |
4.6 | Use effective contraception during treatment, and for at least 7 months after the last dose for female patients of childbearing potential and for at least 4 months after the last dose for male patients with female partners of childbearing potential. |
|
Dolutegravir:
Dovato Tivicay |
4.8 | Sideroblastic anaemia (reversible) reported with dolutegravir-containing regimens. |
|
Estriol:
Ovestin Pessary + Ovestin Vaginal Cream |
4.8 | Dysuria; Genital burning sensation; Vulvovaginal burning sensation |
|
Hyoscine:
Scopolamine Transdermal System |
4.4, 4.8 | Hyperthermia, including fatal cases. |
|
Lisdexamfetamine:
Vyvanse |
4.4 | Can interfere with the test results from certain radioactive diagnostic agents and lead to false-positive diagnostic results. |
| 4.9 | Posterior reversible encephalopathy syndrome (PRES) reported in association with amphetamine overdose. | |
|
Measles + mumps + rubella vaccine: Priorix |
4.3, 4.4 | Contraindicated in patients on current or recent immunosuppressive therapy (includes high dose systemic corticosteroids). |
|
Modafinil:
Modavigil |
4.3, 4.4, 4.6 | Contraindicated during pregnancy; women of childbearing potential must use effective contraception during treatment |
|
Morphine:
DBL Morphine Sulfate Injection |
4.8 | Oesophageal disorder (eg, oesophageal motility disorder, lower oesophageal sphincter relaxation impaired, oesophageal peristalsis decreased) reported with opioid therapy. |
|
Paclitaxel:
Anzatax |
4.6 | Pregnancy: guidance for effective use of contraception increased to 7 months after the last dose for females and to 4 months for males (from 6 and 3 months, respectively). Breastfeeding: Do not breastfeed during treatment and for 2 weeks after the last dose. |
|
Pegfilgrastim:
Ziextenzo |
4.4 | Stevens-Johnson Syndrome (SJS) |
|
Recombinant respiratory syncytial virus pre-fusion F protein:
Arexvy |
4.4, 4.8 | Guillain-Barré Syndrome (GBS): reported very rarely following vaccination in individuals aged ≥60 years. |
|
Pethidine:
DBL Pethidine Hydrochloride Injection |
4.8 | Oesophageal disorder (eg, oesophageal motility disorder, lower oesophageal sphincter relaxation impaired, oesophageal peristalsis decreased) reported with opioid therapy. |
|
Rifampicin + isoniazid:
Rifinah |
4.8 | Hyperuricaemia |
|
Semaglutide:
Wegovy |
4.8 | Hypotension; Orthostatic hypotension |
| 6.6 | Dispose of the pen after 4 doses, even if there is residual solution. | |
|
Teriparatide:
Forteo |
4.8 | Anaemia; Renal impairment |
|
Testosterone:
Androfeme 1 |
4.3 | Contraindicated in females with known or suspected androgen-dependent neoplasia, nephrotic syndrome, history of thromboembolism or hypercalcaemia. |
| 4.5 | Concurrent use of testosterone with ACTH or corticosteroids may result in increased fluid retention and should be monitored, particularly in patients with cardiac, renal or hepatic disease. | |
|
Upadacitinib:
Rinvoq |
4.4 | Hypoglycaemia in patients treated for diabetes – dose adjustments of diabetes medicines may be required if hypoglycaemia occurs. |
|
Vaccinia vaccine: Jynneos |
4.4 | Myo-/pericarditis: Smallpox vaccines have been associated with myo-/pericarditis. Advise vaccinees of symptoms. Urgently refer patients with symptoms to specialists for diagnosis and treatment. |
|
Valproic acid (sodium valproate): Epilim Epilim IV |
4.4, 4.6 | Risk of lower birth weight for the gestational age in children exposed to valproate in utero. |
|
Vedolizumab:
Entyvio |
4.8 | Tubulointerstitial nephritis |
|
Warfarin: Marevan |
4.8 | Leukocytoclastic vasculitis |
* Data sheet sections listed in the table are: 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; 4.7: Effects on ability to drive and use machines; 4.8: Undesirable effects; 4.9: Overdose; 6.6 Special precautions for disposal.
