Drug Safety Update is essential reading for all healthcare professionals, bringing you the very latest information and advice to support the safer use of medicines.

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  • Antiepileptic drugs: new advice on switching between different manufacturers’ products for a particular drug:  Different antiepileptic drugs (AEDs) vary considerably in their characteristics, which influences the risk of whether switching between different manufacturers’ products of a particular drug may cause adverse effects or loss of seizure control.


  • Sodium valproate: special reminder on risk of neurodevelopmental delay in children following maternal use—not for use in pregnancy unless there is no effective alternative:  There is new evidence on neurodevelopmental delay in children following maternal use of sodium valproate. A European review is underway to evaluate all currently available evidence on the association between fetal valproate exposure and neurodevelopmental delay or autism spectrum disorder.



  • Short-acting β2 agonists: restricted use for tocolysis in premature labour:  The use of short-acting β2 agonists (SABAs) for tocolysis in premature labour has been restricted to 48 hours’ maximum parenteral use under specialist supervision, after a European safety review. Oral SABAs should not be used in any obstetric indication.


  • Cabazitaxel (Jevtana▼): risk of medication error resulting in overdose—ensure entire contents of solvent vial is added to concentrate vial:  Cabazitaxel is supplied as a vial of concentrate and a vial of solvent. The concentrate must first be diluted with the solvent supplied before adding to the infusion solution.  It is essential that the entire contents of the solvent vial is added to the concentrate vial to produce a concentrate-solvent mixture with the intended concentration of 10 mg/mL cabazitaxel.


  • Mefloquine: strengthened warnings on neuropsychiatric side effects:  Although the risk of neuropsychiatric side effects with mefloquine is well-established, a recent review of the prescribing information has led to strengthened warnings and new measures to help minimise risks.  To minimise the risk of these adverse reactions, mefloquine must not be used for chemoprophylaxis in patients with active or a history of psychiatric disturbances such as depression, anxiety disorders, schizophrenia, or other psychiatric disorders.


  • Risperidone and paliperidone: risk of intraoperative floppy iris syndrome in patients undergoing cataract surgery:  Cases of intraoperative floppy iris syndrome (IFIS) during cataract surgery have been reported in patients taking the atypical antipsychotics risperidone or paliperidone. IFIS may increase the risk of eye complications during and after cataract surgery.


Posted on the UK MHRA website on 18 November 2013