-
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…
-
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…
-
More than one treatment course is authorised only in women who are not eligible for surgery, and liver function monitoring is to be carried out in all women treated with Esmya. Before initiation, discuss with women the rare …
-
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 …
-
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…
-
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…
-
Letters were sent about Cetrotide (cetrorelix acetate), Eperzan▼(albiglutide), darunavir/cobicistat, Keytruda▼ (pembrolizumab), Denzapine (clozapine) 50 mg/mL oral suspension, and Bleo-Kyowa (bleomycin sulphate).
-
New safety recommendations have been issued while an EU review evaluates cases of neural tube defects in babies born to mothers who became pregnant while taking the HIV medicine dolutegravir.
-
Letters were sent about azithromycin, Lynparza▼(Olaparib), Xgeva▼ (denosumab), Lymphoseek (tilmanocept), ReoPro (abciximab) and dolutegravir; you still have time to complete a quick survey to tell us your views on the way me…
-
Use materials online now and hardcopies arriving over the coming weeks by post to ensure women and girls of childbearing potential on valproate medicines meet the requirements of the Pregnancy Prevention Programme.
-
Letters were sent about insulin Fiasp and Tresiba and Inhixa (enoxaparin sodium); use survey to feedback your thoughts on Direct Healthcare Professional Communications (DHPCs) and on the way medicines safety issues are commu…
-
Valproate medicines must no longer be used in women or girls of childbearing potential unless a Pregnancy Prevention Programme is in place. Ensure all women and girls (and their parent, caregiver, or responsible person, if n…
-
Letters were sent to healthcare professionals about Zinbryta▼ (daclizumab beta), Lynparza 50 mg capsules, and radium-223-dichloride (Xofigo▼).
-
An alert was issued about T34 ambulatory syringe pumps.
-
The European Medicines Agency (EMA) has recommended the immediate suspension of the marketing authorisation and recall of daclizumab (Zinbryta) in the EU following reports of serious inflammatory brain disorders, including e…
-
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.
-
Letters were sent about ellaOne, ERWINASE, Eperzan▼, Ocaliva▼, Velcade, Esmya, and Bleo-Kyowa.
-
Monitor patients closely and remove the vaginal delivery system immediately in cases of excessive or prolonged uterine contractions, at the onset of labour, or if there is clinical concern for mother or baby.
-
Mycophenolate mofetil and its active metabolite mycophenolic acid, both used to prevent transplant rejection, are teratogenic and genotoxic. The available clinical evidence does not indicate an increased risk of malformation…
-
Omniscan and intravenous Magnevist are now no longer authorised for use and a product recall of any existing unexpired stock is underway.
-
Letters were sent about Buccolam (midazolam), misoprostol vaginal delivery system (Mysodelle), noradrenaline, Relenza (zanamivir), mycophenolate mofetil/mycophenolic acid, Flolan, and Fludara.
-
The use of daclizumab (daclizumab beta) is now restricted to adults with relapsing multiple sclerosis who have had an inadequate response to at least 2 other disease-modifying therapies (DMTs) and for whom other DMTs are con…
-
Letters were sent about cladribine (Litak and Leustat), radium-223-dichloride (Xofigo▼), and ERWINASE.
-
Alerts were recently issued about BD Alaris/Asena syringe pumps and Maxter Catheters nasogastric (NG) feeding tubes.
-
A review has found that low levels of gadolinium can be retained in the brain and other tissues after administration of gadolinium-containing contrast agents (GdCAs). There is currently no evidence that gadolinium deposition…
-
Consider progressive multifocal encephalopathy (PML) in the differential diagnosis for patients with new or worsening neurological signs or symptoms, even several years after treatment with cladribine.
-
Fingolimod can cause persistent bradycardia, which can increase the risk of serious cardiac arrhythmias. New contraindications have been introduced for patients with pre-existing cardiac disorders.
-
Monitor patients closely for skin cancers. Advise patients to seek urgent attention if they develop signs or symptoms of serious infections.
-
Letters were sent about eluxadoline (Truberzi), fingolimod (Gilenya), Bleo-Kyowa (bleomycin sulphate), Buccolam (midazolam), and ERWINASE.
-
Quinine has dose-dependent QT-interval-prolonging effects and should be used with caution in patients with risk factors for QT prolongation or in those with atrioventricular block.
-
In addition to the 3 risk-based categories of antiepileptic drugs, patient-related factors should be considered when deciding whether it is necessary to maintain continuity of supply for a specific product.
-
Gabapentin has been associated with a rare risk of severe respiratory depression even without concomitant opioid medicines. Patients with compromised respiratory function, respiratory or neurological disease, renal impairmen…
-
If constipation occurs during treatment with clozapine (Clozaril, Denzapine, Zaponex), it is vital that it is recognised and actively treated.
-
There have been reports of cardiac events including QT prolongation, torsades de pointes, and cardiac arrest in patients who have taken high or very high doses of loperamide as a drug of abuse or for self-treatment of opioid…
-
Letters were sent about ibrutinib, daclizumab, aflibercept, valproate medicines, and arsenic trioxide.
-
While an urgent EU-wide review of new information on liver safety is under way, promptly review patients on treatment. Only initiate daclizumab in restricted groups of patients with limited treatment options and keep all pat…
-
We have received reports of depression and, in rare cases, suicidal thoughts in men taking finasteride 1 mg (Propecia) for male pattern hair loss. Be aware that depression is also associated with finasteride 5 mg (Proscar).
-
A summary of letters sent to healthcare professionals, including an important reminder about the withdrawal of retigabine (Trobalt) from the market.
-
Babies born to mothers who take valproate medicines (Epilim▼, Depakote▼) during pregnancy have a 30–40% risk of developmental disability and a 10% risk of birth defects. Despite communications to prescribers in January 2015 …
-
Healthcare professionals should report any suspected adverse effects relating to fingolimod (Gilenya▼) or other treatments for multiple sclerosis, including suspected adverse effects occurring after discontinuation, via the …
-
A summary of letters sent to relevant healthcare professionals in January 2017.
-
There is an increased risk that some patients may experience psychiatric symptoms with apremilast, including depression and suicidal thoughts. Stop treatment if patients have new psychiatric symptoms or if existing symptoms …
-
A summary of letters sent to relevant healthcare professionals in December 2016.
-
A summary of recent letters sent to relevant healthcare professionals, to inform them of updated safety information.
-
A summary of letters sent to healthcare professionals in September 2016, including important information for professionals who specialise in epilepsy treatment regarding the withdrawal from the market of retigabine (Trobalt).
-
Medicines or herbal remedies that induce CYP3A4 enzymes reduce blood levels of levonorgestrel, which may reduce emergency contraceptive efficacy.
-
Possible illicit drug use should be considered when prescribing medicines that have the potential to interact adversely.
-
There have been rare reports of Nexplanon implants having reached the lung via the pulmonary artery. An implant that cannot be palpated at its insertion site in the arm should be located as soon as possible and removed at th…
-
In May 2016, letters were sent regarding Nexplanon (etonogestrel implant) and ERWINASE.
-
In April 2016, letters were sent regarding canagliflozin (Invokana▼, Vokanamet▼), BCR-ABL tyrosine kinase inhibitors, pomalidomide (Imnovid▼), and retigabine (Trobalt)