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A summary of letters and recent medicine recalls and notifications sent to healthcare professionals.
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A summary of letters and drug alerts recently sent to healthcare professionals.
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Pregabalin has been associated with infrequent reports of severe respiratory depression, including some cases without the presence of concomitant opioid medicines. Patients with compromised respiratory function, respiratory …
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A review of the risks of major congenital malformations and of adverse neurodevelopmental outcomes for antiepileptic drugs by the Commission on Human Medicines has confirmed that lamotrigine (Lamictal) and levetiracetam (Kep…
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The monitoring requirements and discontinuation criteria for dimethyl fumarate (Tecfidera) have been strengthened following a small number of reports of progressive multifocal leukoencephalopathy (PML) in patients with mild …
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Liver monitoring requirements and discontinuation criteria for fingolimod have been updated following reports of serious liver injury. Fatal cases of encephalitis and meningitis caused by herpes simplex and varicella zoster …
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A summary of letters and drug alerts recently sent to healthcare professionals.
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A summary of letters and drug alerts recently sent to healthcare professionals.
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Modafinil potentially increases the risk of congenital malformations when used in pregnancy. Modafinil should not be used during pregnancy and women of childbearing potential must use effective contraception during treatment…
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A summary of letters and drug alerts recently sent to healthcare professionals.
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Before initiating systemic vascular endothelial growth factor (VEGF) pathway inhibitors, carefully consider the risk of aneurysm and artery dissection in patients with risk factors. In patients who receive a systemic VEGF pa…
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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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A summary of letters and drug alerts recently sent to healthcare professionals.
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A summary of letters and drug alerts recently sent to healthcare professionals.
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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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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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In January 2020, healthcare professionals received updated educational materials to support the valproate pregnancy prevention programme. Valproate is contraindicated in girls and women of childbearing potential, unless the …
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Letters were sent about methotrexate, modafinil, Ecalta, Picato, Nexplanon, valproate medicines, e-cigarettes, and Lemtrada. Alerts were issued about finasteride, codeine/paracetamol, and Picato.
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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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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. Key recommendations include new a…
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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. Other alerts issued in October 201…
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Letters were issued about parenteral nutrition products, ranibizumab, ingenol mebutate gel, adrenaline auto-injectors, and fingolimod. Recall alerts were recently issued about ranitidine, aripiprazole, and bisacodyl.
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Alerts were issued about T34 ambulatory syringe pumps, Gripper needles, and 1-day Acuvue Moist for astigmatism contact lenses.
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Fingolimod is associated with an increased risk of major congenital malformations including cardiac, renal, and musculoskeletal defects, when used in pregnancy. Women of childbearing potential must use effective contraceptio…
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Cases of pigmentary maculopathy leading to visual impairment have been reported with pentosan polysulfate, particularly after long-term use at high doses. Ensure patients taking pentosan polysulfate have regular ophthalmic e…
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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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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. Advise patients not to d…
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Letters were sent about Oncaspar▼ (pegaspargase), Ketalar (ketamine) injection, and Elmiron (pentosan polysulfate sodium). A recall was issued for several medicines taken out of the regulated medicines supply chain, includin…
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Letters were sent about Myocrisin (sodium aurothiomalate), Cerliponase alfa (Brineura▼), Darzalex▼(daratumumab), retinoids▼, and febuxostat (Adenuric). A recall alert was issued for medicines that were taken out of the regul…
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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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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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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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Letters were sent about alemtuzumab (Lemtrada), Selenase (sodium selenite pentahydrate), and Erelzi▼ (etanercept).
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We have recently received 2 reports of fatal adverse reactions to the yellow fever vaccine (Stamaril). Due to an increased risk of life-threatening reactions, the vaccine must not be given to anyone with a medical history of…
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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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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. Evaluate patients carefully for a …
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Letters were sent about Xeljanz▼ (tofacitinib), ranitidine, Nulojix (belatacept), fluoroquinolone antibiotics, Genvoya▼, Stribild▼, Tybost, and belimumab (Benlysta▼). Drug alerts were issued about Accord losartan potassium c…
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Disabling, long-lasting or potentially irreversible adverse reactions affecting musculoskeletal and nervous systems have been reported very rarely with fluoroquinolone antibiotics. Fluoroquinolone treatment should be discont…
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Tapentadol may increase seizure risk in patients taking other medicines that lower seizure threshold, for example, antidepressants and antipsychotics. Serotonin syndrome has also been reported when tapentadol is used in comb…
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In December 2018, a letter was sent to notify healthcare professionals of the discontinuation of Zovirax (Aciclovir) eye ointment. We also highlight the recent recall of Actavis batches of irbesartan/hydrochlorothiazide tabl…
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Although use of valproate medicines in female patients continues to slowly decline, there is wide variation in prescribing between Clinical Commissioning Groups (CCGs). Women continue to report instances when they have not r…
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Letters were sent to healthcare professionals about Jext adrenaline autoinjectors, rivaroxaban, Ozurdex 700 micrograms intravitreal implant, sildenafil, hydrochlorothiazide, and Epilim Chronosphere (sodium valproate). We als…
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Interrupt treatment if posterior reversible encephalopathy syndrome (PRES) is confirmed and resume treatment only once the event is resolved and the benefit of continued treatment outweighs the risk of PRES.
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A supply disruption alert was issued by the Department of Health & Social Care (DHSC) on EpiPen and EpiPen Junior; see MHRA advice on extension of use beyond the expiry date for certain batches of EpiPen 300 microgram ad…
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Valproate medicines must not be used in women of childbearing potential unless the Pregnancy Prevention Programme is in place. If you are involved in the care of female patients on valproate in the UK, see a reminder of acti…
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Monitoring for encephalitis should continue for 12 months following discontinuation of daclizumab. Inform all patients who have discontinued daclizumab and their caregivers of the common symptoms of encephalitis and the need…
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Advise patients and their caregivers to seek urgent medical attention if any signs or symptoms of communicating hydrocephalus develop during nusinersen therapy for spinal muscular atrophy. Patients with communicating hydroce…
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Letters were sent about daclizumab beta (Zinbryta▼), alteplase (Actilyse), Esmya (ulipristal acetate), and Xofigo▼ (radium-223-dichloride). MHRA issued alerts and recalls for batches of Nutriflex Omega Special 2500 ml and Nu…
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Letters were sent about valproate medicines, atezolizumab (Tecentriq▼), and nusinersen (Spinraza▼). MHRA issued alerts and recalls for valsartan-containing medicines, Fiasp FlexTouch pre-filled pens, melatonin capsules, and …
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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…