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Recent information relating to COVID-19 vaccines and medicines that has been published since the July 2022 issue of Drug Safety Update, up to 19 August 2022.
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Reporting suspected adverse reactions experienced by the woman or child associated with medicines taken during pregnancy.
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Monitoring blood concentrations of clozapine (Clozaril, Denzapine, Zaponex) for toxicity is now advised in certain clinical situations. Blood level monitoring of other antipsychotics for toxicity may also be helpful in certa…
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New simplified guidance on treating paracetamol overdose with intravenous acetylcysteine including an updated treatment nomogram.
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May cause skin irritation, particularly in children with eczema, possibly due to sodium lauryl sulfate content.
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Extension of the indication for nicotine replacement therapy (NRT) to include harm reduction.
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Letters were sent about Insuman insulin products, mecasermin, and valproate medicines. Recalls were issued about ranitidine medicines and Paclitaxel.
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A UK and Europe-wide review of available efficacy and safety data confirmed that reboxetine has benefit over placebo in its authorised indication.
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Advice on how to use cough and cold medicines safely for children under 12 years.
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All patients with cancer should have a dental check-up before bisphosphonate treatment.
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There have been reports of necrotising and haemorrhagic pancreatitis in people taking exenatide some of which were fatal - stop exenatide treatment if pancreatitis is diagnosed.
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How to reduce risk of illicit use.
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A large study has shown no safety issues of concern relating to the use of metformin during pregnancy. The licence for metformin now reflects that it can be considered for use during pregnancy and the periconceptional phase …
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A summary of recent letters and notifications sent to healthcare professionals about medicines and medical devices, and a recent National Patient Safety Alert asking organisations to put a plan in place to implement new regu…
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If patients are known to be HLA-B*1502-positive, phenytoinshould be avoided when alternative therapy can be given.
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Saquinavir at a reduced dose for the first week of treatment
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7 January 2021 - Advice from the MHRA on the COVID-19 vaccines authorised for use in the UK, including advice for people with allergies and for women during pregnancy and breastfeeding.
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Marketing authorisations for carisoprodol are to be suspended after a European review concluded that the risks of treatment outweigh the benefits.
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The growing number of oral tacrolimus products available on the market increases the potential for inadvertent switching between products, which has been associated with reports of toxicity and graft rejection. Therefore, to…
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Anti-cancer therapy with carfilzomib has been associated with cases of cardiac arrest, cardiac failure, and myocardial infarction, including in patients without pre-existing cardiac disorders. Monitor patients for signs and …
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Recent information relating to COVID-19 vaccines and medicines that has been published since the August 2022 issue of Drug Safety Update, up to 23 September 2022.
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Warnings about the risk of severe and fatal burns are being extended to all paraffin-based emollients regardless of paraffin concentration. Data suggest there is also a risk for paraffin-free emollients. Advise patients who …
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Studies of cardiovascular risk don’t support prescribing changes.
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Updated guidance to use methylphenidateto safely and effectively for attention deficit hyperactivity disorder (ADHD) in children of 6 years or older and adolescents.
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Patients taking warfarin should not use over-the-counter miconazole oral gel (Daktarin). If you plan to prescribe miconazole oral gel in a patient on warfarin, you should closely monitor them and advise that if they experien…
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Healthcare professionals prescribing aripiprazole are reminded to be alert to the risk of addictive gambling and other impulse control disorders. Healthcare professionals should advise patients, their families and friends to…
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Patient reminder cards about the risk of osteonecrosis of the jaw are being introduced; denosumab 120 mg is now contraindicated in patients with unhealed lesions from dental or oral surgery.
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A patient alert card is being introduced for men taking finasteride to help raise awareness of the risk of psychiatric side effects and sexual dysfunction, including the potential for sexual dysfunction to persist after trea…
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Outline of the safety experience of these medicines in the UK from our proactive safety monitoring strategy.
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Oral lidocaine-containing products for infant teething are only to be available under the supervision of a pharmacist so that parents and caregivers can receive guidance about managing infant teething symptoms. Non-medicinal…
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Maternal administration of magnesium sulfate for longer than 5–7 days in pregnancy has been associated with skeletal adverse effects and hypocalcaemia and hypermagnesemia in neonates. If use of magnesium sulfate in pregnancy…
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Following new evidence of cardiovascular, hepatic and pulmonary risk, a review of dronedarone has concluded that the benefits of treatment continue to outweigh the risks for the maintenance of sinus rhythm after successful c…
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Do not use in children aged 16 years or less, except in specialist settings under expert medical supervision.
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We inform healthcare professionals that the Medicines and Healthcare products Regulatory Agency (MHRA) has launched new guidance to highlight the latest safety advice on the steps to take during anaphylaxis. This new guidanc…
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A summary of recent letters, medicine recalls and notifications sent to healthcare professionals
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Recent information relating to COVID-19 vaccines and medicines that has been published since the December 2021 issue of Drug Safety Update, up to 13 January 2022.
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Mycophenolate mofetil and its active metabolite mycophenolic acid are associated with a high rate of serious birth defects and increased risk of spontaneous abortion.
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Atypical femoral fractures reported rarely with bisphosphonate therapy, mainly in patients receiving long-term treatment for osteoporosis.
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The Commission on Human Medicines (CHM) has endorsed changes to the risk minimisation measures for isotretinoin, following a review of the impact of the measures implemented in 2023.…
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Gadolinium-containing contrast agents are associated with a varying degree of risk of nephrogenic systemic fibrosis. See advice below to minimise risk in the following vulnerable groups: patients with renal impairment; patie…
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In light of the most recent evidence, the previous advice on the concomitant use of clopidogrel with proton pump inhibitors has now been modified. Use of either omeprazole or esomeprazole with clopidogrel should be discourag…
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Abacavir should be used in line with current treatment guidelines and with caution in patients with high cardiovascular risk factors.
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Advice for healthcare professionals regarding the withdrawal of pholcodine-containing medicines from the market.
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The Commission on Human Medicines (CHM) has endorsed changes to isotretinoin prescribing guidance. In addition, CHM is seeking further information from dermatology services who prescribe isotretinoin to inform any future changes to current risk minimisation measures.
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A summary of recent letters and notifications sent to healthcare professionals about medicines and medical devices.
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Key MHRA advice and guidance issued so far on medicines safety and pharmacovigilance, including on reporting to the Yellow Card Scheme.
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Contact patients currently taking Esmya for uterine fibroids as soon as possible and advise them to stop their treatment. The licence for Esmya has been suspended to protect public health while a safety review is conducted f…
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We remind healthcare professionals that isotretinoin should only be used for severe forms of acne resistant to adequate courses of standard therapy with systemic antibacterials and topical therapy. Prescription of isotretino…
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The annual #MedSafetyWeek campaign takes place from 3 to 9 November 2025. This year’s campaign theme is ‘we can all help make medicines safer.’
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We have initiated a new safety review into topiramate as a result of an observational study reporting an increased risk of neurodevelopmental disabilities in children whose mothers took topiramate during pregnancy.
Topir…