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Summary report on the risk of suicidal thoughts and behaviour related to antidepressants.
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Systemic piroxicam should be initiated only by specialists as a second-line treatment for arthritis, with patients who currently take piroxicam reassessed at a routine appointment.
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Use baricitinib with caution in patients with diverticular disease and in those concomitantly treated with medications associated with an increased risk of diverticulitis.
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Risk of serious haemorrhage—clarified contraindications apply to all 3 medicines.
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In April 2016, letters were sent regarding canagliflozin (Invokana▼, Vokanamet▼), BCR-ABL tyrosine kinase inhibitors, pomalidomide (Imnovid▼), and retigabine (Trobalt)
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A UK and Europe-wide review of available efficacy and safety data confirmed that reboxetine has benefit over placebo in its authorised indication.
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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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Remain vigilant for signs and symptoms of bleeding complications during treatment with DOACs (apixaban, dabigatran, edoxaban, rivaroxaban), especially in patients with increased bleeding risks. Specific reversal agents are a…
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Indication restricted to nausea and vomiting, new contraindications, and reduced dose and duration of use.
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Cases of severe hypersensitivity syndromes, sometimes fatal, have been reported with etravirine.
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A case of progressive multifocal leukoencephalopathy (PML) with a fatal outcome was reported in a patient with rheumatoid arthritis who had not previously received treatment with methotrexate or a TNF antagonist.
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Atomoxetine is associated with treatment-emergent psychotic or manic symptoms in children and adolescents - consider stopping this if symptoms occur.
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Decreased vitamin B12 levels, or vitamin B12 deficiency, is now considered to be a common side effect in patients on metformin treatment, especially in those receiving a higher dose or longer treatment duration and in those …
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Incorrect dosage of bivalirudin in percutaneous coronary intervention can lead to major adverse cardiac events.
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Prescribing information has been updated to introduce a lower recommended dose of 60 mg daily for patients with rheumatoid arthritis or ankylosing spondylitis.
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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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In light of feedback, we have clarified our article on concomitant use of these medicines in heart failure.
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Five cases of necrotising fasciitis have been reported in patients treated with panitumumab in combination with chemotherapy.
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Possible illicit drug use should be considered when prescribing medicines that have the potential to interact adversely.
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Fatal cases of tumour lysis syndrome (TLS) have been reported, some occurring in patients with chronic lymphocytic leukaemia receiving the lowest venetoclax dose used in the dose-titration schedule. For all patients, it is i…
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Further evidence that the cardiovascular risk with diclofenac is higher than other non-selective NSAIDs and similar to the selective COX-2 inhibitors.
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Updated contraindications and maximum dose recommendations when taken with a number of other medicines.
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Healthcare professionals reminded that tacrolimus may be associated with possible risk of malignancy.
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Initiate orlistat treatment only after careful consideration of the possible impact on efficacy of antiretroviral HIV medicines.
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Healthcare professionals should be aware of this risk when prescribing prasugrel.
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Onsenal▼ (celecoxib) is no longer approved in Europe for the reduction of intestinal polyps in familial adenomatous polyposis (FAP).
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Patients should be advised to promptly report to their doctor any changes in their breast tissue such as lumps, pain, or nipple discharge.
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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 …
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Available evidence shows that the risk of blood vessel blockage with ponatinib is likely to be dose-dependent, however the data are insufficient to recommend reducing the ponatinib dose.
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Febuxostat must be stopped immediately if hypersensitivity occurs and must not be re-started in patients who have ever developed a hypersensitivity reaction to febuxostat.
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Prescribers should consider reducing the dose of ponatinib to 15 mg a day for patients with chronic phase chronic myeloid leukaemia (CP-CML) who have achieved a major cytogenetic response.
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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).
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Patients should be assessed regularly due to reported cases of suicidal ideation and suicidal behaviour during treatment with duloxetine or shortly after stopping treatment.
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Recent epidemiological evidence of an increased risk of fracture with long-term use of proton pump inhibitors (PPIs).…
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The maximum recommended dose for simvastatin in conjunction with amlodipine and diltiazem is now 20 mg/day.
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Erythromycin has been associated with events secondary to QT interval prolongation such as cardiac arrest and ventricular fibrillation. Erythromycin should not be given to patients with a history of QT interval prolongation…
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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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How MHRA monitors the impact of regulatory action taken.
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Linezolid is not active against infections caused by Gram-negative pathogens, and treatment should be started only after specialist microbiological advice.
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Use trametinib, authorised either as monotherapy or combined with dabrafenib, with caution in patients with risk factors for gastrointestinal perforation.
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New advice to minimise risk
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Healthcare professionals should be aware of the updated information so they can discuss it with new and existing patients.
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Risk minimisation materials are available to support the safe use of new paediatric formulations of rivaroxaban (Xarelto) and dabigatran etexilate (Pradaxa). In addition, we ask healthcare professionals to consult the curren…
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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.
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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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Serious liver injury has been reported during treatment with pirfenidone in the first year after initiation, including 2 cases with a fatal outcome. Measure alanine aminotransferase (ALT), aspartate aminotransferase (AST), a…
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Risk of thrombosis and haemorrhage in patients with prosthetic heart valve(s) requiring anti-coagulant treatment.
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Pharmacokinetic data indicate exposure of elvitegravir boosted with cobicistat (Genvoya▼, Stribild) is lower during the second and third trimesters of pregnancy than postpartum. Low elvitegravir exposure may be associated wi…
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SSRIs and SNRIs are known to increase bleeding risks due to their effect on platelet function. Data from observational studies suggest that the use of SSRI/SNRI antidepressants during the month before delivery may result in …
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High intravenous doses of methylthioninium chloride (methylene blue) should be avoided for patients being treated with serotonergic antidepressants (eg, SSRIs, clomipramine, and venlafaxine).