Published: 7 December 2023


Recent data sheet updates: important new safety information

Published: 7 December 2023
Prescriber Update 44(4): 77–78
December 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

Click on the specific medicine to open the data sheet.

Active ingredient(s): Data sheet updates
  • Medicine(s)
Section* Summary of new safety information
Amoxicillin + clavulanic acid: 4.4 Drug-induced enterocolitis syndrome
4.5 Interaction with methotrexate
4.8 As per 4.4
Bupropion + naltrexone 4.4 Severe cutaneous adverse reactions (SCARs); Brugada syndrome (due to bupropion component)
4.8 As per 4.4
Cabergoline: 4.4 Hypertension, myocardial infarction, seizures, stroke or psychiatric disorders in post-partum women treated for inhibition of lactation
4.8 As per 4.4
Ceftriaxone: 4.2 No dose changes in mild to moderate liver impairment; maximum dose of 2g daily in severe renal impairment
4.3 Premature neonates, full-term neonates at risk of developing bilirubin encephalopathy, and neonates who require calcium-containing IV solutions
4.4 Hypersensitivity reactions: before treatment, check if patient has had previous severe hypersensitivity reactions to any beta-lactam antibiotics; severe cutaneous adverse reactions (SCAR) have been reported. New warnings for: renal lithiasis; risk of bilirubin encephalopathy in neonates; lidocaine; history of gastrointestinal disease; long-term treatment; antibacterial spectrum; severe renal and hepatic insufficiency
4.5 Calcium-containing diluents; use with oral anticoagulants
Estriol: 4.4 Hereditary and acquired angioedema; hepatitis C
4.5 Use caution with co-administration of hepatitis C combination regimens
4.8 Angioedema
Fluorouracil: 4.4 May be fatal if ingested by pets
Gabapentin: 4.4 Withdrawal symptoms; women of childbearing potential/contraception
4.6 Neonatal withdrawal syndrome; results from pregnancy study
4.8 Withdrawal symptoms
Glecaprevir + pibrentasvir: 4.5 May be used with products containing 20µg or less of ethinylestradiol
Hydroxychloroquine: 4.4 Chronic cardiac toxicity: drug-induced phospholipidosis; hepatoxicity; hepatitis B reactivation; skeletal muscle myopathy or neuropathy; renal toxicity
4.6 Congenital malformations
4.8 Renal phospholipidosis; hepatitis B reactivation
Levonorgestrel: 4.4 Pregnancy; precautions before use; precautions after use; paediatric use (not indicated for use in prepubertal children, limited data in under 16-year-olds)
Methadone: 4.2 Treatment goals and discontinuation
4.4 Opioid use disorder and withdrawal
4.5 Gabapentinoids; cannabidiol
4.8 Central sleep apnoea syndrome
4.9 Hypoglycaemia
Methotrexate: 4.6 Men should use contraception and/or not donate semen during treatment and for 3 months after cessation of treatment
4.8 Brain oedema; pulmonary oedema
Ticagrelor: 4.2 Consider discontinuation of acetylsalicylic acid (ASA; aspirin) after 3 months in patients with acute coronary syndrome who have undergone a percutaneous coronary intervention procedure and have an increased risk of bleeding
4.4 As per 4.2
Tobramycin: 4.4 Ototoxicity in patients with mitochondrial DNA mutations
Tramadol: 4.8 Hypoglycaemia
Vedolizumab: 4.6 Concentration of vedolizumab in breast milk; estimated average daily dose ingested by the infant
4.8 Rate of infections in patients with BMI ≥30 kg/m2 was higher than those with BMI <30 kg/m2; updated immunogenicity data

* 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; 4.8: Undesirable effects; 4.9: Overdose

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).

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