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Systemically administered VEGF pathway inhibitors: risk of aneurysm and artery dissection
Before initiating systemic vascular endothelial growth factor (VEGF) pathway inhibitors, carefully consider the risk of aneurysm and artery dissection in patients with risk factors.
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Liposomal and lipid-complex formulations: name change to reduce medication errors
Make a clear distinction between liposomal, pegylated-liposomal, lipid-complex and conventional formulations when prescribing, dispensing, administering, and communicating about these medicines.
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Letters and drug alerts sent to healthcare professionals in June 2020
A summary of letters and drug alerts recently sent to healthcare professionals.
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Medical Device Alerts issued in June 2020
A summary of Medical Device Alerts recently issued by the MHRA.
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Cyproterone acetate: new advice to minimise risk of meningioma
Risk of meningioma with cyproterone acetate increases with increasing cumulative dose.
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Direct-acting oral anticoagulants (DOACs): reminder of bleeding risk, including availability of reversal agents
Remain vigilant for signs and symptoms of bleeding complications during treatment with DOACs (apixaban, dabigatran, edoxaban, rivaroxaban), especially in patients with increased bleeding risks.
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Letters and drug alerts sent to healthcare professionals in May 2020
A summary of letters and drug alerts recently sent to healthcare professionals.
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Coronavirus (COVID-19): new dedicated Yellow Card reporting site for medicines and medical devices
Reporting to the new site will enable the MHRA to rapidly identify new and emerging side effects and medical device incidents in COVID-19 treatment, including side effects for medicines taken by patients to manage long-term …
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Valproate Pregnancy Prevention Programme: temporary advice for management during coronavirus (COVID-19)
Guidance has been published to support initiation of valproate in female patients and for annual review and pregnancy testing during the coronavirus pandemic.
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Immunomodulatory drugs and pregnancy prevention: temporary advice for management during coronavirus (COVID-19)
Guidance has been published about thalidomide, lenalidomide, and pomalidomide and the use of remote consultations and home pregnancy testing for patients taking them during COVID-19.
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Letters and drug alerts sent to healthcare professionals in April 2020
A summary of letters and drug alerts recently sent to healthcare professionals.
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Coronavirus (COVID-19): latest guidance for medicines safety
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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Letters and drug alerts sent to healthcare professionals in March 2020
A summary of letters and drug alerts recently sent to healthcare professionals.
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Esmya (ulipristal acetate): suspension of the licence due to risk of serious liver injury
Contact patients currently taking Esmya for uterine fibroids as soon as possible and advise them to stop their treatment.
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Tofacitinib (Xeljanz▼): new measures to minimise risk of venous thromboembolism and of serious and fatal infections
Caution should be used in patients with known risk factors for venous thromboembolism in addition to the underlying disease.
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Baricitinib (Olumiant▼): risk of venous thromboembolism
Discontinue baricitinib treatment permanently if clinical features of deep vein thrombosis or pulmonary embolism occur.
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SGLT2 inhibitors: monitor ketones in blood during treatment interruption for surgical procedures or acute serious medical illness
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.
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Benzodiazepines and opioids: reminder of risk of potentially fatal respiratory depression
Benzodiazepines and opioids can both cause respiratory depression, which can be fatal if not recognised in time.
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Letters and drug alerts sent to healthcare professionals in February 2020
Letters were sent on Typhim Vi vaccines, Mepact (mifamurtide), and Xeljanz (tofacitinib) and an alert issued to recall Emerade 150 microgram adrenaline pens.
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Medical Device Alerts issued in February 2020
Alerts were issued about CME T34 and T34L (T60) ambulatory syringe pumps, Cardinal Health tympanic thermometers, t:slim X2 insulin pump, and Mavidon skin preparation electrode gels.
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Ingenol mebutate gel (Picato▼): suspension of the licence due to risk of skin malignancy
Stop prescribing Picato and consider other treatment options for actinic keratosis as appropriate.
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Lemtrada▼ (alemtuzumab): updated restrictions and strengthened monitoring requirements following review of serious cardiovascular and immune-mediated reactions
A review of the benefits and risks of alemtuzumab (including fatal reactions) in the treatment of multiple sclerosis has now concluded and recommended a revised indication, additional contraindications, and strengthened moni…
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Valproate (Epilim▼, Depakote▼) pregnancy prevention programme: updated educational materials
In January 2020, healthcare professionals received updated educational materials to support the valproate pregnancy prevention programme.
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Nexplanon (etonogestrel) contraceptive implants: new insertion site to reduce rare risk of neurovascular injury and implant migration
Amended advice on the insertion site for Nexplanon contraceptive implants following concerns regarding reports of neurovascular injury and implants migrating to the vasculature (including the pulmonary artery).
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Support Yellow Card: report suspected reactions in patients taking multiple medicines
Be especially alert for adverse drug reactions (ADRs) in patients taking more than one medicine and report any suspected ADRs to the Yellow Card Scheme.
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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.
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Medical Device Alerts issued in January 2020
Alerts were issued about Convex two-piece skin barriers for use with ostomy bags and HeartStart XL+ defibrillators.
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E-cigarette use or vaping: reporting suspected adverse reactions, including lung injury
Be vigilant for any suspected adverse reactions associated with use of e-cigarettes or vaping (including lung injury) and report them to the MHRA via the Yellow Card Scheme.
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Ondansetron: small increased risk of oral clefts following use in the first 12 weeks of pregnancy
Recent epidemiological studies suggest exposure to ondansetron during the first trimester of pregnancy is associated with a small increased risk of the baby having a cleft lip and/or cleft palate.
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Mecasermin (Increlex▼): risk of benign and malignant neoplasia
Cases of benign and malignant neoplasms have been observed among children and adolescents who received treatment with mecasermin.
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Letters and drug alerts sent to healthcare professionals in December 2019
Letters were sent about Insuman insulin products, mecasermin, and valproate medicines.
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Medical Device Alerts issued in December 2019
Alerts were issued about Arrow EZ-IO intraosseous vascular access needle sets, Medicina IV Luer Slip syringes, and Spectra Optia apheresis systems.
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Letters and drug alerts sent to healthcare professionals in November 2019
Letters were sent about ranibizumab and Emerade adrenaline auto-injectors.
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Domperidone for nausea and vomiting: lack of efficacy in children; reminder of contraindications in adults and adolescents
Domperidone is no longer licensed for use in children younger than 12 years or those weighing less than 35 kg.
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Yellow fever vaccine: stronger precautions in people with weakened immunity and in those aged 60 years or older
The Commission on Human Medicines has issued a series of recommendations to strengthen measures to minimise risk with the yellow fever vaccine (Stamaril) following very rare fatal reactions.
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Carfilzomib (Kyprolis▼): risk of reactivation of hepatitis B virus
Establish hepatitis B status before initiating carfilzomib and in patients with unknown hepatitis B virus serology who are already being treated with carfilzomib.
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Letters and drug alerts sent to healthcare professionals in October 2019
Letters were sent about quadrivalent influenza vaccine, fentanyl ampoules, and Volibris (ambrisentan), and a number of pharmacy-level recalls were issued for ranitidine-containing products.
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Medical Device Alerts issued in October 2019
Alerts were issued about Rocket and NuSurgix fetal blood sampling (FBS) amnioscopes and kits, Philips Efficia professional-use defibrillators/monitors, and CME T-34 3rd edition syringe driver pumps.
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Ingenol mebutate gel (Picato▼): increased incidence of skin tumours seen in some clinical studies
Advise patients treated with ingenol mebutate gel to be vigilant for new skin lesions and to seek medical advice immediately should any occur.
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Nivolumab (Opdivo): reports of cytomegalovirus (CMV) gastrointestinal infection or reactivation
Patients on nivolumab 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 infection…
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Prescribing medicines in renal impairment: using the appropriate estimate of renal function to avoid the risk of adverse drug reactions
For most patients and most medicines, estimated Glomerular Filtration Rate (eGFR) is an appropriate measure of renal function for determining dosage adjustments in renal impairment; however, in some circumstances, the Cockcr…
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Adrenaline auto-injectors: recent action taken to support safety
Healthcare professionals should be aware of alerts and letters issued about adrenaline auto-injectors in September and October 2019.
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Letters and drug alerts sent to healthcare professionals in September 2019
Letters were issued about parenteral nutrition products, ranibizumab, ingenol mebutate gel, adrenaline auto-injectors, and fingolimod.
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Medical Device Alerts issued in September 2019
Alerts were issued about T34 ambulatory syringe pumps, Gripper needles, and 1-day Acuvue Moist for astigmatism contact lenses.
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Fingolimod (Gilenya▼): increased risk of congenital malformations; new contraindication during pregnancy and in women of childbearing potential not using effective contraception
Fingolimod is associated with an increased risk of major congenital malformations including cardiac, renal, and musculoskeletal defects, when used in pregnancy.
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Elmiron (pentosan polysulfate sodium): rare risk of pigmentary maculopathy
Cases of pigmentary maculopathy leading to visual impairment have been reported with pentosan polysulfate, particularly after long-term use at high doses.
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Montelukast (Singulair): reminder of the risk of neuropsychiatric reactions
Prescribers should be alert for neuropsychiatric reactions in patients taking montelukast and carefully consider the benefits and risks of continuing treatment if they occur.
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Letters and drug alerts sent to healthcare professionals in August 2019
A letter was sent to advise healthcare professionals about a restriction to the indication and route of administration for Mitomycin-C Kyowa 40 mg following the observation of increased sub-visible particles in the drug prod…
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Medical Devices Alerts issued in August 2019
An alert was issued advising against use of Dermapen 3 and Dermapen Cryo Sterile single use needle cartridge tips for Dermapen 3 since their safety cannot be verified.
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Hormone replacement therapy (HRT): further information on the known increased risk of breast cancer with HRT and its persistence after stopping
New data have confirmed that the risk of breast cancer is increased during use of all types of HRT, except vaginal estrogens, and have also shown that an excess risk of breast cancer persists for longer after stopping HRT th…