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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…
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Daratumumab (Darzalex▼): risk of reactivation of hepatitis B virus
Establish hepatitis B virus status before initiating daratumumab and in patients with unknown hepatitis B virus serology who are already being treated with daratumumab.
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Naltrexone/bupropion (Mysimba▼): risk of adverse reactions that could affect ability to drive
Advise patients that naltrexone/bupropion has been associated with adverse reactions such as dizziness or somnolence, which can affect ability to drive, operate machinery, or perform dangerous tasks.
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Carfilzomib (Kyprolis▼): reminder of risk of potentially fatal cardiac events
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.
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Letters and drug alerts sent to healthcare professionals in July 2019
Letters were sent about Oncaspar▼ (pegaspargase), Ketalar (ketamine) injection, and Elmiron (pentosan polysulfate sodium).
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Medical Devices Alerts issued in July 2019
Alerts were issued about Telefunken automated external defibrillators and BD Microtainer capillary blood specimen collection tubes.
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Febuxostat (Adenuric): increased risk of cardiovascular death and all-cause mortality in clinical trial in patients with a history of major cardiovascular disease
Avoid treatment with febuxostat in patients with pre-existing major cardiovascular disease (for example, myocardial infarction, stroke, or unstable angina), unless no other therapy options are appropriate.
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Tocilizumab (RoActemra): rare risk of serious liver injury including cases requiring transplantation
Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) levels should be measured before starting treatment with tocilizumab and monitored every 4–8 weeks for the first 6 months of treatment followed by every 12 …
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Rivaroxaban (Xarelto▼): reminder that 15 mg and 20 mg tablets should be taken with food
MHRA has received a small number of reports suggesting lack of efficacy (thromboembolic events) in patients taking 15 mg or 20 mg rivaroxaban on an empty stomach; remind patients to take 15 mg or 20 mg rivaroxaban tablets wi…
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Letters and drug alerts sent to healthcare professionals in June 2019
Letters were sent about Myocrisin (sodium aurothiomalate), Cerliponase alfa (Brineura▼), Darzalex▼(daratumumab), retinoids▼, and febuxostat (Adenuric).
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Medical Device Alerts issued in June 2019
An alert was issued about Dialog+ haemodialysis machines.
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Direct-acting oral anticoagulants (DOACs): increased risk of recurrent thrombotic events in patients with antiphospholipid syndrome
A clinical trial has shown an increased risk of recurrent thrombotic events associated with rivaroxaban compared with warfarin, in patients with antiphospholipid syndrome and a history of thrombosis.
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GLP-1 receptor agonists: reports of diabetic ketoacidosis when concomitant insulin was rapidly reduced or discontinued
Diabetic ketoacidosis has been reported in patients with type 2 diabetes on a combination of a GLP-1 receptor agonist and insulin who had doses of concomitant insulin rapidly reduced or discontinued.
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Lartruvo▼ (olaratumab): withdrawal of the EU marketing authorisation due to lack of efficacy
The ANNOUNCE study failed to show clinical efficacy for olaratumab in its current indication of advanced soft tissue sarcoma and the benefit risk balance is therefore now considered negative.
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Oral retinoid medicines▼: revised and simplified pregnancy prevention educational materials for healthcare professionals and women
New prescriber checklists, patient reminder cards, and pharmacy checklists are available to support the Pregnancy Prevention Programme in women taking acitretin, alitretinoin, and isotretinoin.
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Letters and drug alerts sent to healthcare professionals in May 2019
Letters were sent about tofacitinib (Xeljanz▼), Trisenox (arsenic trioxide), lapatinib (Tyverb), direct-acting oral anticoagulants, and Lartruvo▼ (olaratumab).
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Medical Device Alerts issued in May 2019
Alerts were issued about paclitaxel drug coated balloons (DCBs) and implantable drug-eluting stents (DESs) in the treatment of patients with peripheral artery disease, and Aisys and Aisys CS2 anaesthesia devices.
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Lemtrada (alemtuzumab) and serious cardiovascular and immune-mediated adverse reactions: new restrictions to use and strengthened monitoring requirements
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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Tofacitinib (Xeljanz▼): restriction of 10 mg twice-daily dose in patients at high risk of pulmonary embolism while safety review is ongoing
Following observation in a clinical study of an increased risk of pulmonary embolism and overall mortality with tofacitinib 10 mg twice-daily in rheumatoid arthritis, a safety review has started and new contraindications int…
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Magnesium sulfate: risk of skeletal adverse effects in the neonate following prolonged or repeated use in pregnancy
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.
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Yellow Card: please help to reverse the decline in reporting of suspected adverse drug reactions
2018 saw a fall in reporting of suspected adverse drug reactions (ADRs) to the Yellow Card Scheme from key reporter groups, including GPs, pharmacists, and hospital doctors.
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Letters and drug alerts sent to healthcare professionals in April 2019
Letters were sent about alemtuzumab (Lemtrada), Selenase (sodium selenite pentahydrate), and Erelzi▼ (etanercept).
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Medical Device Alerts issued in April 2019
An alert was issued about Moift Mover 180/205 mobile hoist and Molift Air ceiling hoist.
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Yellow fever vaccine (Stamaril) and fatal adverse reactions: extreme caution needed in people who may be immunosuppressed and those 60 years and older
We have recently received 2 reports of fatal adverse reactions to the yellow fever vaccine (Stamaril).
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Valproate medicines and serious harms in pregnancy: new Annual Risk Acknowledgement Form and clinical guidance from professional bodies to support compliance with the Pregnancy Prevention Programme
Ongoing patient survey data suggest that more effort is needed by clinicians to achieve full and timely compliance with the valproate Pregnancy Prevention Programme and meet the goal to rapidly reduce and eventually eliminat…
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Belimumab (Benlysta▼): increased risk of serious psychiatric events seen in clinical trials
Clinical trials, including interim findings from a randomised trial, show an increased risk of depression, suicidal ideation or behaviour, or self-injury in patients with systemic lupus erythematosus receiving belimumab comp…
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Pregabalin (Lyrica), gabapentin (Neurontin) and risk of abuse and dependence: new scheduling requirements from 1 April
As of 1 April 2019, pregabalin and gabapentin are controlled under the Misuse of Drugs Act 1971 as Class C substances and scheduled under the Misuse of Drugs Regulations 2001 as Schedule 3.
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Elvitegravir boosted with cobicistat: avoid use in pregnancy due to risk of treatment failure and maternal-to-child transmission of HIV-1
Pharmacokinetic data indicate exposure of elvitegravir boosted with cobicistat (Genvoya▼, Stribild) is lower during the second and third trimesters of pregnancy than postpartum.
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