MHRA – Drug Safety Update
Medicines related to valproate: risk of abnormal pregnancy outcomesChildren exposed in utero to valproate are at a high risk of serious developmental disorders (in up to 30-40% of cases) and/or congenital malformations (in approximately 10% of cases).https://www.gov.uk/drug-safety-update/medicines-related-to-valproate-risk-of-abnormal-pregnancy-outcomes
Ustekinumab (Stelara): risk of exfoliative dermatitisIf you suspect exfoliative dermatitis caused by an adverse drug reaction to ustekinumab, stop treatment.https://www.gov.uk/drug-safety-update/ustekinumab-stelara-risk-of-exfoliative-dermatitis
Mycophenolate mofetil (CellCept) and mycophenolic acid: risk of hypogammaglobulinaemia and risk of bronchiectasisMeasure serum immunoglobulin levels if recurrent infections develop.https://www.gov.uk/drug-safety-update/mycophenolate-mofetil-cellcept-and-mycophenolic-acid-risk-of-hypogammaglobulinaemia-and-risk-of-bronchiectasis
Oral diclofenac no longer available without prescriptionOral diclofenac is associated with a small increased risk of cardiovascular side effects and is therefore no longer available over the counter.https://www.gov.uk/drug-safety-update/oral-diclofenac-no-longer-available-without-prescription
Aceclofenac (Preservex): updated cardiovascular advice in line with diclofenac and COX-2 inhibitorsAceclofenac is now contraindicated in patients with certain established cardiovascular diseases.https://www.gov.uk/drug-safety-update/aceclofenac-preservex-updated-cardiovascular-advice-in-line-with-diclofenac-and-cox-2-inhibitors
Yellow Card extended to include devices, counterfeits and defective medicinesWe have simplified our medicine and device incident report systems by bringing them all under the Yellow Card Scheme.https://www.gov.uk/drug-safety-update/yellow-card-extended-to-include-devices-counterfeits-and-defective-medicines Download this edition as a PDF file
Drug Safety Update is a monthly newsletter from the Medicines and Healthcare products Regulatory Agency (MHRA) and its independent advisor the Commission on Human Medicines.
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United Kingdom - MHRA - Medicines and Healthcare Products Regulatory Agency