Published: 6 March 2025
Publications
Recent data sheet updates: important new safety information
Published: 6 March 2025
Prescriber Update 46(1): 17–18
March 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) | Sectiona | Summary of new safety information |
| Aflibercept Eylea |
4.8 | Scleritis |
| Alectinib Alecensa |
4.6 | Increase in contraception requirements for female patients of childbearing potential from 1 week post last dose to 5 weeks post last dose |
| Baclofen Pacifen |
4.4 | Encephalopathy |
| 4.8 | Encephalopathy; Hypersensitivity; Alopecia; Sexual dysfunction; Swelling face; Peripheral oedema | |
| Carbamazepine Tegretol |
4.3, 4.4 | Contraindicated in neonates below 4 weeks of age due to the propylene glycol (PG) content and the immaturity of both metabolic and renal clearance of PG in this population |
| 4.6 | Additional information added to Pregnancy risk summary: Microcephaly; Small for gestational age (SGA); Neurodevelopmental disorders (Autism spectrum disorder, Intellectual disability, ADHD) | |
| Celecoxib Celebrex (Aspen) |
4.4, 4.8 | Skin: Fixed drug eruptions (FDE) and generalised bullous fixed drug eruptions (GBFDE) |
|
Chlorhexidine Chlorhexidine Acetate Chlorhexidine Acetate with Cetrimide |
4.4 | Preoperative skin preparation: Eye contact must be avoided. Permanent corneal injury has been reported |
| 4.8 | Fatal anaphylactic reaction; Corneal erosion; Corneal epithelium defect/Corneal injury; Visual impairment | |
| Colecalciferol Vit.D3 |
4.3 | Additional contraindications: Nephrolithiasis; Pregnancy; Lactation; Children under 18 years of age |
| 4.4 | Use with caution in patients with arteriosclerosis, cardiac function impairment, sarcoidosis, other granulomatous diseases. New sections: Monitoring; Renal impairment; Hepatic impairment; Long-term administration | |
| 4.5 | New interactions: Calcium, Phosphate; Digoxin; Corticosteroids; Rifampicin; Isoniazid; Antifungals; Actinomycin; Different vitamin D analogues | |
| 4.6 | Do not use during pregnancy or while breastfeeding | |
| 4.9 | Updated overdose symptoms; toxicity in paediatric population | |
| Diclofenac Voltaren Rapid Extra Strength |
4.8 | Kounis syndrome |
| Hydrocortisone + natamycin + neomycin | 4.2 | Only use when a combination of a corticosteroid, antimycotic and antibiotic is indicated. Do not apply to genital areas. |
| 4.4 | Local skin reactions | |
| Isotretinoin Oratane |
4.3 | Contraindicated during breastfeeding; Concomitant use with tetracyclines is contraindicated due to the risk of benign intracranial hypertension |
| 4.4 | Paediatric use: Not recommended for children aged under
12 years; use with caution in those aged 12 to 17 years Skin and subcutaneous disorders: Use sunscreen with SPF50 Musculoskeletal and connective tissue disorders: Sacroiliitis |
|
| 4.8 | Sacroiliitis; Urethritis | |
| Leflunomide Arava |
4.4 | Skin reactions: Impaired wound healing after surgery that may require treatment interruption and a washout procedure |
| Meropenem Meropenem-AFT |
4.4 | Rhabdomyolysis; Neurological sequelae; Skin and subcutaneous tissue disorders |
| 4.8 | Acute generalised exanthematous pustulosis (AGEP); Rhabdomyolysis; Kounis syndrome | |
| Midazolam Midazolam-Baxter |
4.1, 4.2 | Now indicated only for the intravenous and intramuscular routes of administration |
| 4.4 | Paediatric use: Safety and effectiveness in children below the age of 8 years have not been established. | |
| 4.6 | Increased risk of miscarriage when used during pregnancy | |
| Propofol Diprivan |
4.8 | Hepatitis; Acute hepatic failure |
| Testosterone Testogel |
4.4 | Inadvertent testosterone transfer: Skin to skin transfer – pregnant women and children; Precautions for the patient and to improve partner safety |
| 4.8 | Anxiety; Decreased libido; Emotional lability; Prostate abnormalities; Benign prostate hyperplasia; Prostatomegaly prostatic disorder; Spermatogenesis and semen disorders; Oligospermia; Testicular atrophy; Azoospermia | |
- Data sheet sections listed in the table are: 4.1: Therapeutic indications; 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; 4.9: Overdose.
- See also the Gathering Knowledge article on page 12 for a case of genital ulceration following use of Pimafucort.
