Published: 7 March 2024
Publications
Recent data sheet updates: important new safety information
Published 7 March 2024
Prescriber Update 45(1): 22–24
March 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, see Section 10 ‘Date of revision of the text’ (at the end of each data sheet). Search for a data sheet
See also the new and updated 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 |
| Cabozantinib Cabometyx | 4.4 | Systemic anticoagulation therapy. Hepatoxicity: vanishing bile duct syndromeb |
| 4.8 | Monotherapy table, new ADRs: cutaneous vasculitis, pneumonia, embolism arterial. Combination therapy table, new ADRs: cutaneous vasculitis, vanishing bile duct syndrome, embolism arterial | |
| Cefotaxime DBL™ Cefotaxime | 4.8 | Kounis syndromec |
| Dasatinib Sprycel | 4.4 | Hepatoxicity |
| 4.8 | ||
| Diazoxide DBL™ Diazoxide | 4.8 | Pericardial effusion |
| Dolutegravir
Tivicay Dovato |
4.6 | Pregnancy: no increased risk of neural tube defects with exposure at conception |
| Durvalumab Imfinzi | 4.2 | Treatment modifications for immune-mediated Guillain-Barré syndrome (GBS) |
| 4.4 | Other immune-mediated adverse reactions: GBS, immune-mediated arthritis | |
| 4.8 | Uveitis, immune-mediated arthritis, GBS | |
| Fluorouracil Fluorouracil Accord | 4.6 | Pregnancy: women of childbearing age should avoid pregnancy, use highly effective contraception during pregnancy and for at least 6 months after the last dose; men should not father a child during and for at least 3 months following cessation of treatment |
| Finasteride Propecia | 4.8 | Suicidal ideation |
| Glatiramer acetate Copaxone | 4.6 | Lactation: updated with human data |
| Hydroxychloroquine Plaquenil | 4.5 | Interactions with CYP inhibitors/inducers and P-gp substrates |
| Hyoscine Scopoderm | Newly published data sheet | |
| Lamivudine Zeffix | 4.4 | Advice for use in patients with HIV/HBV co-infection |
| Lamotrigine Lamictal | 4.8 | Erythema multiforme |
| Mercaptopurine Puri-nethol | 4.1 | Removal of chronic granulocytic leukaemia |
| 4.4 | Warnings for: hepatoxicity – cholestasis of pregnancy; NUDT15 mutation; macrophage activation syndrome; metabolism and nutrition disorders; paediatric population; galactose intolerance, complete lactase deficiency or glucose-galactose malabsorption | |
| 4.8 | Hypoglycaemia, stomatitis, cholestasis of pregnancy, bacterial and viral infections, infections associated with neutropenia, mucosal inflammation | |
| Minocycline Mino Tabs (Minomycin) | 4.2 | Administration instructions to reduce the risk of oesophageal irritation ulceration. Maximum doses for children >12 years of age |
| 4.4 | Hyperpigmentation | |
| 4.8 | Fixed drug eruptions, enamel hypoplasia, decreased hearing, headache not related to benign intracranial hypertension | |
| Nirmatrelvir + ritonavird Paxlovid | 4.3 | Contraindications for concomitant use with eplerenone, eletriptan, naloxegol, tolvaptan, primidone |
| 4.8 | Stevens Johnson syndrome, toxic epidermal necrolysis | |
| Nusinersen Spinraza | 4.8 | Arachnoiditis |
| Oxcarbazepine Trileptal | 4.6 | Pregnancy: EURAP registry results, potential risk of congenital malformations and neurodevelopment disorders. Lactation: infant exposure |
| Plerixafor Mozobil | 4.6 | Pregnancy: should not be used during pregnancy; women of childbearing potential and men should use effective contraception during treatment and for one week after cessation |
| Rifabutin Mycobutin | 4.3 | Contraindication for concomitant use with rilpivirine |
| 4.4 | Warnings for interactions with elvitegravir, plus anti-HCV medicines such as sofosbuvir | |
| 4.5 | Interactions with atazanavir/ritonavir, darunavir/ritonavir, dolutegravir, elvitegravir/cobicistat, etravirine, sofosbuvir, bedaquilline, ethinylestradiol/norethindrone | |
| Rifampicin + isoniazid Rifinah | 4.4 | Cerebellar syndrome |
| 4.8 | ||
| Rosuvastatin
Crestor Rosuvastatin Viatris |
4.5 | Interaction with ticagrelor |
| Simvastatin Simvastatin Viatris | 4.4 | Myasthenia gravis, ocular myasthenia |
| 4.5 | Interaction with ticagrelor | |
| 4.8 | Myasthenia gravis, ocular myasthenia | |
| Ustekinumab Stelara | 4.6 | Pregnancy: data for first trimester exposure does not indicate an increased risk of fetal malformations in the newborn |
| Valproic acid (sodium valproate)e
Epilim Epilim IV |
4.4 | Males of reproductive potential: increased risk of neurodevelopmental disorders (NDD) in children born to men treated with valproate in the 3 months prior to conception; risks to children fathered more than 3 months after stopping treatment are unknown; if discontinuing treatment, continue effective contraception for 3 months; inform patients to avoid donating sperm during treatment and for 3 months after stopping treatment |
| Varicella zoster virus (recombinant) vaccine Shringrix | 4.5 | May be given concomitantly with pneumococcal conjugate vaccine (PCV) or COVID-19 mRNA vaccine |
- 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
- See the September 2023 Prescriber Update article about vanishing bile duct syndrome
- As a class effect of beta-lactam antibiotics. See the September 2020 Prescriber Update article about Kounis syndrome
- See the Paxlovid Dear Healthcare Professional Letter (PDF, 7 pages, 630KB)
- See the Epilim alert communication and Dear Healthcare Professional Letter (PDF, 2 pages, 179 KB)
