Published: 1 June 2023
Publications
Recent data sheet updates: important new safety information
Published: 1 June 2023
Prescriber Update 44(2): 34–35
June 2023
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.
Table 1: Recently updated data sheets (by active ingredient): important new safety information
| Active ingredient(s) | Medicine | Section | Data sheet updates |
|---|---|---|---|
| Summary of new safety information | |||
| Atezolizumab | Tecentriq | 4.2 | Dose modifications: recommendations for patients with immune-mediated myelitis, immune-mediated facial paresis, haemophagocytic lymphohistiocytosis (HLH) |
| 4.4 | Warnings and precautions: immune-mediated myelitis, immune-mediated facial paresis, HLH | ||
| 4.8 | Undesirable effects: immune-mediated myelitis, immune-mediated facial paresis, HLH, dry mouth | ||
| Carboplatin | Carboplatin Accord | 4.9 | Overdose: no known antidotes, overdose enhances expected toxic effects, may result in death |
| Carboplatin | Carboplatin DBL | 4.6 | Fertility: continue to use contraception for 7 months after treatment for females and for 4 months after treatment for males. Breastfeeding: discontinue breastfeeding during treatment and 1 month after treatment, or discontinue treatment |
| Dulaglutide | Trulicity | 4.8 | Undesirable effects: constipation, flatulence, abdominal distension, gastroesophageal reflux disease, eructation |
| Esketamine | Spravato | 4.4 | Warnings and precautions: hepatotoxicity with chronic ketamine use |
| Etanercept | Enbrel | 4.4 | Warnings and precautions: uveitis |
| 4.6 | Pregnancy: contraception recommendations for females of childbearing potential. Lactation: live vaccine administration in breastfed infants | ||
| Etopophos | Etopophos | 4.4 | Warnings and precautions: secondary leukaemia, tumour lysis syndrome |
| 4.5 | Interactions: medicines with similar myelosuppressive effects (additive effect) | ||
| 4.8 | Undesirable effects: severe myelosuppression, other toxicities, infertility | ||
| Ezetimibe + simvastatin | Zimybe | 4.8 | Undesirable effects: vision blurred, visual impairment, lichenoid drug eruptions, muscle rupture, gynaecomastia |
| Fludarabine | Fludara Oral | 4.6 | Fertility, pregnancy and lactation: strengthens warnings for females; males to use effective contraception during treatment and for 95 days after treatment |
| Levothyroxine | Synthroid | 4.3 | Contraindications: acute myocarditis, acute pancarditis |
| 4.4 | Warnings and precautions: biotin interference with thyroid immunoassays | ||
| 4.5 | Interactions: St John’s wort, biotin | ||
| Loperamide | Diamide | 4.8 | Undesirable effects: acute pancreatitis |
| Rosuvastatin | Crestor | 4.4 | Warnings and precautions: myasthenia gravis, ocular myasthenia |
| 4.6 | Pregnancy and lactation: elaborates on pregnancy and lactation warnings, lactation data added | ||
| 4.8 | Undesirable effects: ocular myasthenia, myasthenia gravis, lichenoid drug eruption | ||
| Topiramate* | Topamax | 4.4 | Warnings and precautions: strengthens warnings in women of childbearing potential |
| 4.6 | Pregnancy: monotherapy is preferred for antiepileptic drugs (AEDs) in general. With topiramate, increased risk of neurodevelopmental disorders in infants exposed in utero |
* See the Medsafe alert communication: Topiramate use in pregnancy: further restrictions for safety
More information
To find out if sponsors have made any changes to their data sheets, see Section 10 ‘Date of revision of the text’ (at the end of each data sheet).
