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Before starting treatment with pomalidomide, establish hepatitis B virus status in all patients.
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Should not be used for cough under 18 years
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While an urgent EU safety review evaluates reports of serious cardiovascular events and immune-mediated reactions, including autoimmune hepatitis, the use of alemtuzumab (Lemtrada) has been restricted and strengthened requir…
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The authorised dose regimen for N-acetylcysteine (NAC) in paracetamol overdose is 3 consecutive bags given intravenously over 21 hours. Prescribing information is being updated to advise that continued treatment with NAC may…
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A new study has suggested pregabalin may slightly increase the risk of major congenital malformations if used in pregnancy. Patients should continue to use effective contraception during treatment and avoid use in pregnancy …
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Monitor serum phosphate levels in patients treated with multiple high-dose administrations, or those on long-term treatment, and in those with pre-existing risk factors for hypophosphataemia. Re-evaluate ferric carboxymaltos…
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Healthcare professionals should advise patients and/or carers of the changes in the dose, packaging, dose dispenser and leaflet.
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Rare cases of atypical femoral fracture with long-term use.
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Cases of severe cutaneous adverse reactions, including Stevens-Johnsons syndrome (SJS) and toxic epidermal necrolysis (TEN), have been reported in patients treated with immune-stimulatory anti-cancer drugs, including atezoli…
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The human papillomavirus (HPV) immunisation programme is now entering its second year and this article summarises the safety experience to date.
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A summary of recent letters and notifications sent to healthcare professionals about medicines and medical devices.
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Now only authorised for use in patients with symptomatic bone metastases and no known visceral metastases who have had 2 previous systemic treatments for metastatic castration-resistant prostate cancer or who cannot receive …
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New pharmacokinetic data show mean exposure of darunavir (brand name Prezista) boosted with cobicistat (available in combination in Rezolsta▼, Symtuza▼) to be lower during the second and third trimesters of pregnancy than du…
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Use a lower starting dose of thalidomide in patients with untreated multiple myeloma who are older than age 75 years.
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If new movement disorders occur during treatment consider dose reduction or a gradual discontinuation of treatment in consultation with specialist advice.
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Some batches of gentamicin sulphate active pharmaceutical ingredient (API) used to manufacture gentamicin may contain higher than expected levels of histamine, which is a residual from the manufacturing process. Monitor pati…
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We are providing an update on a retrospective observational study on the risk to children born to men who took valproate in the 3 months before conception and on the need for the re-analysis of the data from this study befor…
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Maintenance doses of brolucizumab (after the first 3 doses) should not be given at intervals of less than 8 weeks apart.
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Onivyde has been associated with reports of serious thromboembolic events, such as pulmonary embolism, venous thrombosis, and arterial thromboembolism.
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Solu-Medrone 40 mg may contain trace amounts of milk proteins. Do not use in patients with a known or suspected allergy to cows’ milk.
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Updated dosing for paediatric paracetamol liquids has been developed to ensure children receive the optimum dose for their age.
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The third-line treatment indication for rucaparib has been withdrawn following a review of the findings of the ARIEL-4 trial, which showed lower overall survival for rucaparib treatment versus standard chemotherapy in patien…
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We ask healthcare professionals to be vigilant to adverse incidents involving software, apps, and artificial intelligence (AI) as medical devices and to report incidents to us via the Yellow Card scheme.
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New recommendations after a Europe-wide review of cardiovascular safety.
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Drug interactions involving CYP2D6, genetic variants, and variability in clinical response
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Dental examination and appropriate preventive dentistry should be considered before treatment, especially for patients also treated with an intravenous bisphosphonate.
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New monitoring instructions to detect these side effects as soon as possible.
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Most herbal medicines on the UK market are currently unlicensed products and it is difficult for consumers or healthcare professionals to identify which products are manufactured to acceptable standards with reliable product…
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Letters were sent about tofacitinib (Xeljanz▼), Trisenox (arsenic trioxide), lapatinib (Tyverb), direct-acting oral anticoagulants, and Lartruvo▼ (olaratumab). Alerts were issued about Epanutin (phenytoin) oral solution, Mac…
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Recent information relating to COVID-19 vaccines and medicines that has been published since the October 2021 issue of Drug Safety Update, up to 12 November 2021.
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The most important risk factors for uterine perforation are insertion during lactation and insertion in the 36 weeks after giving birth. Before inserting an IUS or IUD, inform women of the risk and the symptoms of perforatio…
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Monitor thyroid-stimulating hormone (TSH) in patients treated with levothyroxine for at least the first month after starting and ending ritonavir treatment.
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Recent information relating to COVID-19 vaccines and medicines that has been published since the November 2021 issue of Drug Safety Update, up to 3 December 2021.
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Measure serum immunoglobulin levels if recurrent infections develop. Consider bronchiectasis or pulmonary fibrosis if patients develop persistent respiratory symptoms.
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All patients with cancer should have a dental check-up before bisphosphonate treatment.
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MHRA has received reports of unintentional overdose of fentanyl due to dosing errors, accidental exposure, and exposure of the patch to a heat source.
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Patients on ipilimumab who present with diarrhoea or other symptoms of colitis, and those who do not respond to steroid treatment for immune-related colitis, should be investigated to exclude other causes, including infectio…
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Care needed to minimise risk of error, including training for patients.
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Discontinue baricitinib treatment permanently if clinical features of deep vein thrombosis or pulmonary embolism occur. Prescribers are reminded to use caution if using baricitinib in patients with risk factors for deep vein…
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Updated advice for healthcare professionals is available, after conclusion of a review of the safety of idelalisib, including the risk of infection.
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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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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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EU review confirms that the cardiovascular risk of high-dose ibuprofen (≥2400mg/day) is similar to COX 2 inhibitors and diclofenac.
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Indication restricted to nausea and vomiting, new contraindications, and reduced dose and duration of use.
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New contraindications and warnings for combination of aliskiren (Rasilez) with angiotensin-converting enzyme (ACE) inhibitors or angiotensin receptor blockers (ARBs).
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Report to the Yellow Card Scheme suspected adverse reactions associated with medicines taken during pregnancy experienced by women or the baby or child. Obstetricians and midwives have a particularly important role in provid…
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Repeat enhanced cardiovascular monitoring when restarting fingolimod after treatment interruption,
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Studies of cardiovascular risk don’t support prescribing changes.
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SGLT2 inhibitor treatment should be interrupted in patients who are hospitalised for major surgical procedures or acute serious medical illnesses and ketone levels measured, preferably in blood rather than urine. Treatment m…
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Temporary safety measures are in place while an EU review investigates the link between cases of serious liver injury, including 4 cases requiring liver transplantation, and Esmya for uterine fibroids.