Published: 5 September 2024
Publications
Recent data sheet updates: important new safety information
Published: 5 September 2024
Prescriber Update 45(3): 66–68
September 2024
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 | Data sheet updates | |
|---|---|---|
| Medicine(s) | Sectiona | Summary of new safety information |
| Acetylcysteine DBL Acetylcysteine |
4.4 | Patients with asthma or history of bronchospasm; Patients with a history of oesophageal varices and peptic ulcer |
| Allergens and grass pollen extract Oralair |
4.4 | Severe allergic reactions; Previous systemic allergic reaction to allergen immunotherapy; Asthma; Cardiovascular diseases; Beta-adrenergic blockers; MAOIs, tricyclic antidepressants and COMT inhibitors; Mild to moderate local allergic reactions; Autoimmune diseases in remission; Lactose |
| Amphotericin B AmBisome |
4.2 | Dose updates for Systemic mycoses (including mucormycosis, cryptococcal meningitis) and Empirical treatment of presumed fungal infection of febrile neutropenic patients |
| Anastrozole Aremedb |
4.4 | Tenosynovitis, tendonitis, tendon rupture |
| Atazanavir Atazanavir Viatris |
4.5 | Apalutamide; Other lipid-modifying agents; Antiplatelets; Antineoplastics; Gonadotropin-releasing hormone antagonist receptor antagonists; Kinase inhibitors; Dexamethasone and other corticosteroids |
| Bupropion Zyban |
4.4 | Brugada syndrome |
| 4.8 | Alopecia | |
| Busulfan Myleran |
4.5 | Deferasirox; Paracetamol |
| Cyclizine Cyclizine lactate (injection) Nausicalm (tablet) |
4.2 | Use in hepatic impairment |
| 4.4 | General warnings; Nervous system | |
| 4.6 | Use in breastfeeding women is not recommended | |
| Doxorubicin Caelyx |
4.4, 4.8 | Interstitial lung disease |
| 4.6 | Women of childbearing potential should avoid pregnancy, and use effective contraception during treatment and for 8 months after stopping; Men with female partners of childbearing potential should use effective contraception, and not father a child during treatment and for up to 6 months after stopping | |
| Diazoxide DBL Diazoxide |
4.4, 4.8 | Necrotising enterocolitis in neonates and infants |
| Digoxin Lanoxin |
4.5 | Increase effects of digoxin: posaconazole, osimertinib; Decrease effects of digoxin: acarbose |
| Droperidol Droleptan Droperidol Panpharma |
4.3 | Pheochromocytoma |
| 4.4 | Central nervous system; Cardiovascular (arrhythmia) | |
| 4.5 | Medicines that induce extrapyramidal symptoms; Medicines that induce electrolyte imbalance; CYP1A2 and CYP3A4 inhibitors | |
| 4.7 | Major influence on ability to drive or operate machinery; Wait at least 24 hours after last dose | |
| 4.8 | New table of adverse effects | |
| Dulaglutide Trulicity |
4.4 | Gastroparesis; Pulmonary aspiration |
| 4.8 | Intestinal obstruction including ileus; Elevated liver enzymes | |
| Epirubicin Epirubicin Ebewe |
4.4 | Embryo-fetal toxicity |
| 4.6 | Use contraception during treatment, and for at least 3.5 months after last dose for males and at least 6.5 months after last dose for females; Avoid breastfeeding during treatment and for at least 7 days after last dose | |
| Etanercept Enbrel |
4.8 | Glomerulonephritis |
| Montelukast Montelukast Viatris |
4.4 | Neuropsychiatric events in adults, adolescents and childrenc |
| Nifedipine Nyefax Retard |
4.3 | Patients with acute or unstable cardiovascular disease or significant gastrointestinal disease. |
| 4.8 | Peripheral oedema; Pulmonary oedema; Intestinal ulcer; Intestinal obstruction; Bezoar; Dysphagia | |
| Nintedanib Ofev |
4.4, 4.8 | Posterior reversible encephalopathy syndrome (PRES) |
| Ondansetron (injection) Ondansetron AFT Ondansetron Kabi |
4.2 | Dose restrictions in elderly patients due to the risk of dose-dependent QT prolongation |
| 4.4, 4.8 | Myocardial ischaemia | |
| Ondansetron (tablets) Onrex |
4.4, 4.8 | QT prolongation; Myocardial ischaemia |
| Pegaspargase Oncaspar |
4.4, 4.8 | Veno-occlusive disease (VOD) |
| Pravastatin Pravastatin Viatris |
4.4 | Contains lactose; Myasthenia gravis/Ocular myastheniad |
| 4.5 | Colchicine; Nicotinic acid; Rifampicin; Coumarin anticoagulant | |
| 4.8 | Myasthenia gravis; Ocular myasthenia; Fatal and non-fatal hepatic failure | |
| Sulfadiazine silver Flamazine |
4.4, 4.8 | Stevens-Johnson syndrome (SJS); Toxic epidermal necrolysis (TEN) |
| Terlipressin Glypressin |
4.4 | Cardiovascular and pulmonary disease; Renal impairment; Hepatic impairment; Respiratory events; Sepsis/septic shock; Skin necrosis (unrelated to the injection site) |
| 4.8 | Sepsis/septic shock | |
| Vinblastine DBL Vinblastine |
4.6 | Women of childbearing potential: avoid pregnancy, use highly effective contraception during treatment and for 7 months after the last dose; Men with female partners of childbearing potential: use highly effective contraception during treatment and for at least 4 months after the last dose. Do not breastfeed during treatment and for 1 week following the last dose |
- 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; 4.7: Effects on ability to drive and use machinery; 4.8: Undesirable effects
- See the drug-induced tendinopathy article.
- See the article about unexplained mood and behavioural changes in the March 2024 edition of Prescriber Update.
- See the myasthenia gravis article.
