Letters and drug alerts sent to healthcare professionals in July 2018

Letters were sent about valproate medicines, atezolizumab (Tecentriq▼), and nusinersen (Spinraza▼). MHRA issued alerts and recalls for valsartan-containing medicines, Fiasp FlexTouch pre-filled pens, melatonin capsules, and sodium cromoglicate eye drops.

• From: Medicines and Healthcare products Regulatory Agency
• Published: 24 August 2018

• Therapeutic area: Cancer, Cardiovascular disease and lipidology, Dermatology, Endocrinology, diabetology and metabolism, Immunology and vaccination, Neurology, Obstetrics, gynaecology and fertility, Ophthalmology, Paediatrics and neonatology, Pain management and palliation, Psychiatry, Respiratory disease and allergy, Urology and nephrology

In July 2018, the following letters were sent from licence holders to healthcare professionals about the safety of medicines:

• Valproate (Epilim▼, Depakote▼): new restrictions on use; pregnancy prevention programme to be put in place (for specialists and specialist nurses managing patients treated with valproate medicines and general practitioners who provide primary care to these patients)

• Valproate (Epilim▼, Depakote▼): new restrictions on use: pregnancy prevention programme; important actions for pharmacists

• Tecentriq▼(atezolizumab): Restriction of indication for the treatment of locally advanced or metastatic urothelial carcinoma in adults who are not eligible for cisplatin-containing chemotherapy

• Spinraza▼ (nusinersen): reports of communicating hydrocephalus not related to meningitis or bleeding

In July 2018, MHRA issued the following Alerts and recalls for drugs:

• Class 1 Medicines Recall: Action Now – including out of hours Pharmacy Level Recall 5 July 2018– Pharmacies in the UK are being advised to recall all batches of valsartan containing medicines made by Actavis Group PTC (now Accord) and Dexcel Pharma Ltd due to contamination.

• Class 2 Medicines Recall: Fiasp FlexTouch 100 units/mL solution for injection pre-filled pen manufactured by Novo Nordisk (MDR 065-06/18) 9 July 2018 – Novo Nordisk is recalling one batch as a precautionary measure due to the presence of particles in a small number of samples.

• Melatonin 10mg capsules: Company-led recall 17 July 2018 – IPS Specials are recalling specific batches of Melatonin 10 mg capsules because they have been assigned an incorrect extended expiry date.

• Class 3 Medicines Recall: Sodium Cromoglicate eye drops and Murine Hayfever Relief eye drops (MDR 072-05/17) 30 July 2018 – FDC International Ltd are recalling specific batches of Sodium Cromoglicate 2% w/v Eye Drops 13.5ml and Murine Hayfever Relief 2% w/v Eye Drops 10ml due to the presence of a precipitate, which has been identified as Sodium Cromoglicate, in some bottles.

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Article citation: Drug Safety Update volume 12, issue 1; August 2018: 2.

Published 24 August 2018