Published: 3 September 2026
Publications
Recent data sheet updates: Important new safety information
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) / Class Medicine(s) |
Data sheet updates | |
|---|---|---|
| Sectiona | Summary of new safety information | |
|
Atorvastatin Lorstat |
4.8 | Depression |
|
Atovaquone + proguanil Malarone |
4.8 | Psychiatric disorders including abnormal dreams, depression, anxiety, panic attacks, crying, nightmares, psychotic disorders |
|
Captopril DP-Captopril |
4.4 | Hypersensitivity/Angioedema: May occur particularly during the first week of treatment with ACE inhibitors but can also develop after months or years of treatment. Immediately discontinue treatment and give emergency therapy. |
| 4.4, 4.8 | Insulin Autoimmune Syndrome (IAS):b Cases of IAS have been reported, including severe hypoglycaemic events. If suspected, discontinue use and treat appropriately. | |
|
Ciclosporin Neoral, Sandimmun |
4.4, 4.5 | Interactions: Avoid concomitant use of St John’s wort (Hypericum perforatum) as it may decrease ciclosporin blood levels and potentially impact the clinical efficacy of ciclosporin. |
|
Clobazam Frisium |
4.4, 4.8 | Drug reaction with eosinophilia and systemic symptoms syndrome (DRESS) |
|
CFTR modulatorsc Alyftrek, Kalydeco, Orkambi, Symdeko, Trikafta |
4.4 | Mood disturbances: Effects on mood and behaviour, such as anxiety, low mood, sleep disturbance and forgetfulness have occasionally been reported. |
|
Dexamethasone Dexmethsone |
4.8 | Panniculitis |
|
Doxycycline
Doxine |
4.4 | Severe skin reactions: Exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN) and DRESS have been reported with doxycycline treatment. If severe skin reactions occur, discontinue treatment immediately and treat appropriately. |
|
Fingolimod Gilenya |
4.4 | Infections/Progressive Multifocal Leukoencephalopathy (PML): Immune reconstitution inflammatory syndrome (IRIS) has been reported after discontinuation of Gilenya in patients who developed PML on treatment. Monitor for signs of IRIS following Gilenya cessation. |
|
Fludarabine
Fludarabine Ebewe |
4.6 | Effects on fertility: Male patients must use effective methods of contraception and be advised to not father a child while receiving fludarabine, and at least for 3 months following completion of treatment. |
|
Fludrocortisone
Florinef |
4.8 | Panniculitis |
|
Glofitamab Columvi |
4.4, 4.8 | Serious infections: PML, including fatal cases, has occurred in patients treated with Columvi. Monitor patients for new or worsening neurological toxicities. |
|
Inclisiran Leqvio |
4.8 | Hypersensitivity including anaphylactic reaction, angioedema, rash, urticaria, pruritus |
|
Metformin-containing products
Metformin Viatris Jardiamet |
4.4 | Patients with known or suspected mitochondrial diseases: Metformin is not recommended for use in these patients, such as those with Mitochondrial encephalopathy with lactic acidosis and stroke-like episodes (MELAS) syndrome and Maternal inherited diabetes and deafness (MIDD) |
|
Primidone Primidone (Clinect) |
4.4 | Vitamin D: Primidone may affect vitamin D metabolism. Monitor bone density in patients on long-term treatment and consider vitamin D supplementation. Severe skin reactions: SJS and TEN have been reported. The risk is highest during the first few weeks of primidone treatment. Advise patients of the signs and monitor closely. |
| 4.6 | Contraception: Women of childbearing potential should use effective contraception during treatment with primidone and for 2 months after stopping treatment. | |
|
Quetiapine Quetapel |
4.4 | New warnings for Venous thromboembolism, Orthostatic hypotension, Serotonin syndrome with concomitant use of other serotonergic agents, Body temperature regulation, Interference with laboratory tests |
|
RSV pre-fusion F protein Arexvy |
4.5 | May be given concomitantly with pneumococcal vaccine or COVID-19 mRNA vaccine |
|
Rifampicin + isoniazid Rifinah |
4.3, 4.5 | Contraindicated when given concurrently with daclatasvir, sofosbuvir, telaprevir, lurasidone |
|
Semaglutide Wegovy |
4.4, 4.8 | Patients with gastroparesis: Patients with gastroparesis may experience more serious or severe gastrointestinal adverse events. Use with caution in these patients. |
|
Sumatriptan Clustran |
4.6, 4.8 | Breast pain |
| 4.8 | Cerebellar infarction | |
|
Tretinoin Vesanoid |
4.5 | Interaction with antifungal agents such as posaconazole, voriconazole, ketoconazole and itraconazole |
|
Tirzepatide Mounjaro |
4.8 | Non-arteritic ischaemic optic neuropathy (NAION) |
|
Tranexamic acid Cyklokapron |
4.8 | Renal cortical necrosis (eg, after severe blood loss, such as after post-partum haemorrhage) |
|
Voriconazole Vfend |
4.5 | Co-administration of voriconazole with mavacamten may increase mavacamten plasma concentration and increase the risk of heart failure |
|
Zuclopenthixol Clopixol |
4.4 | Neuroleptic malignant syndrome (NMS): Rhabdomyolysis may occur as a rare complication of NMS |
Key: CFTR = Cystic fibrosis transmembrane conductance regulator; RSV = Recombinant respiratory syncytial virus
- 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; 4.8: Undesirable effects.
- See the June 2026 edition of Prescriber Update for more information about Insulin autoimmune syndrome.
- See the Spotlight on CFTR modulators article in this edition of Prescriber Update.
