Published: 5 December 2024
Publications
Recent data sheet updates: important new safety information
Prescriber Update 45(4): 95–96
December 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(s) | Data sheet updates | |
|---|---|---|
| Medicine(s) | Sectiona | Summary of new safety information |
| Amoxicillin + clavulanic acid Augmentin |
4.8 | Symmetrical drug-related intertriginous and flexural exanthema (SDRIFE)b |
| Baclofen Lioresal Intrathecal |
4.4 | Withdrawal effects: tachycardia |
| 4.8 | Hypersensitivity | |
| 4.9 | Overdose symptoms: tachycardia, tinnitus | |
| Bumetanide Burinex |
4.4, 4.8 | Toxic epidermal necrolysis (TEN) and Stevens Johnson Syndrome (SJS) |
| Busulfan Myleran |
4.2 | Should only be used and administered by specialist clinicians experienced in cancer chemotherapy |
| Cefalexin Cefalexin Sandoz |
4.8 | SDRIFEb |
| Clarithromycin Klacid |
4.5 | Interactions with hydroxychloroquine/chloroquine, corticosteroids, ivabradine |
| Eptifibatide Eptifibatide Viatris |
4.3 | Do not use to treat patients with concomitant or planned administration of a thrombolytic agent (high risk of bleeding) |
| Flucloxacillin Flucil |
4.5 | Interactions with methotrexate, warfarin, posaconazole and voriconazole |
| 4.8 | SDRIFEb | |
| Gadobutrol Gadovist |
4.8 | Acute respiratory distress syndrome (ARDS); Pulmonary oedema |
| Glofitamab Columvi |
4.2, 4.4, 4.7, 4.8 | Immune effector cell-associated neurotoxicity syndrome (ICANS) |
| Hydroxychloroquine Plaquenil | 4.4 | Reactivation of infections: herpes zoster, tuberculosis, hepatitis B |
| Infliximab Remicade |
4.2 | Consider delaying treatment if the patient has a planned surgical procedure |
| 4.8 | Post-procedural complications (infectious and non-infectious); Paradoxical drug-induced immune disorder (eg, new onset psoriasis) | |
| Lamotrigine Lamictal |
4.2, 4.4, 4.5 | Interaction with oestrogen-containing therapies, including hormone replacement therapies |
| 4.8 | Pseudolymphoma | |
| Lidocaine Xylocaine |
4.4 | Kounis syndrome |
| Lithium Lithium carbonate Priadel |
4.3 | Contraindicated in Brugada syndrome or family history of Brugada syndrome |
| 4.4 | Bariatric surgery: dose reductions and monitoring; Brugada syndrome: unmasking or aggravation; QT prolongation: avoid in patients with congenital long QT syndrome, use with caution in patients with risk factors or concomitant use with medicines that prolong the QT interval | |
| 4.8 | Brugada syndrome; Drug reaction with eosinophilia and systemic symptoms (DRESS); Cardiomyopathy; Cutaneous ulcers; Lichenoid drug reactions; Parathyroid adenoma; Parathyroid hyperplasia; Myoclonus; Encephalopathy; Peripheral neuropathy; Delirium; Rhabdomyolysis; Nephrotic syndrome | |
| Morphine sulfate Sevredol |
4.4, 4.8 | Acute generalised exanthematous pustulosis (AGEP) |
| Nirmatrelvir + ritonavir Paxlovid |
4.6 | Discontinue breastfeeding during treatment and for 48 hours after completing treatment |
| Remdesivir Veklury |
4.2 | Removal of renal testing requirement; No dose adjustment in renal or hepatic impairment |
| 4.6 | Pregnancy: do not use during first trimester, use in second or third trimesters only if benefits outweigh risks | |
| Ropivacaine + fentanyl Naropin with Fentanyl |
4.4 | Horner’s syndrome |
| 4.6 | Foetal bradycardia | |
| 4.8 | Anaphylactic shock | |
| Valaciclovir Vaclovir |
4.8 | Headache; Aggressive behaviour; Delirium |
| Valproic acid (sodium valproate) Epilim |
4.8 | Hyperpigmentation |
| Venetoclax Venclexta |
4.2, 4.8, 5.1 | New dose regimen and safety information for Venclexta in combination with ibrutinib |
| Vortioxetine Brintellix |
4.4 | Sexual dysfunction |
- 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 machines; 4.8: Undesirable effects; 4.9: Overdose; 5.1: Pharmacodynamic properties.
- See the December 2023 Prescriber Update article about SDRIFE.
