Letters and drug alerts sent to healthcare professionals in January 2020

Letters were sent about methotrexate, modafinil, Ecalta, Picato, Nexplanon, valproate medicines, e-cigarettes, and Lemtrada. Alerts were issued about finasteride, codeine/paracetamol, and Picato.

• From: Medicines and Healthcare products Regulatory Agency
• Published: 12 February 2020

• Therapeutic area: Anaesthesia and intensive care, Cancer, Dermatology, Infectious disease and Neurology
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  Obstetrics, gynaecology and fertility, Paediatrics and neonatology, Pain management and palliation, Psychiatry, Respiratory disease and allergy, and Rheumatology

Letters

• Methotrexate for autoimmune diseases: recommendations to reduce potentially fatal dosing errors

• Modafinil: potential risk of congenital malformations during pregnancy

• Ecalta 100mg (anidulafungin): Solution for infusion must no longer be frozen

• Lemtrada▼ (alemtuzumab): Restricted indication, additional contraindications and risk minimisation measures (see accompanying Drug Safety Update)

• Nexplanon (etonogestrel 68 mg, implant for subdermal use): update to the insertion and removal instructions to minimise the risks of neurovascular injury and implant migration (see accompanying Drug Safety Update

• ▼Picato (ingenol mebutate) – Suspension of the marketing authorisation due to risk of skin malignancy (see accompanying Drug Safety Update)

• Valproate (Epilim▼, Depakote▼): Pregnancy Prevention Programme – revised educational materials (see accompanying Drug Safety Update):

  • Letter for all pharmacists dispensing valproate medicines
  • Letter for specialists and specialist nurses, general practitioners, and other healthcare professionals who provide care to patients treated with valproate medicines

In January 2020, the MHRA sent a letter to professional organisations asking healthcare professionals to be vigilant for and report any adverse reactions associated with e-cigarettes or vaping (see Drug Safety Update from January 2020).

Drug alerts from January 2020

Class 4 Medicines Defect Information: Dr. Reddy’s Laboratories (UK) Ltd, Finasteride 5 mg Tablets, PL 08553/0261 (EL (20)A/03). Issued 29 January 2020. The Patient Information Leaflet (PIL) provided with the batches listed in the alert is missing warning and precautions documented in the Summary of Product Characteristics regarding the risk of mood alterations and depression. Ensure that patients are aware of any missing information in the leaflet and understand the need to seek medical advice in cases of psychiatric symptoms.

Class 4 Medicines Defect Information: Advanz Pharma Zapain 30mg/500mg Tablets (Codeine Phosphate /Paracetamol), PL12762/0034, (EL(20)A/01). Issued 14 January 2020. Pharmacies should be aware of a discrepancy on the product packaging for the batches listed in the alert. The discrepancy relates to “capsules” printed at the top right of the packs in error, instead of tablets.

In January 2020, a Class 2 Medicines Recall was also issued for Picato gel ▼ due to concerns on the possible risk of skin malignancy – See Drug Safety Update.

Article citation: Drug Safety Update volume 13, issue 7: February 2020: 6.

Published 12 February 2020