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You should take caution when you use NSAIDs in patients with renal impairment or are at risk.
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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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New recommendations after a Europe-wide review of cardiovascular safety.
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Use restricted to adults with advanced or metastatic breast cancer only.
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Epidemiological data suggest that the use of SSRIs in pregnancy, particularly in the later stages, may increase the risk of persistent pulmonary hypertension in the newborn. Healthcare professionals are encouraged to enquire…
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Patients receiving apomorphine and domperidone require an assessment of cardiac risk factors and ECG monitoring to reduce the risk of serious arrhythmia related to QT-prolongation.
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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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Atypical femoral fractures reported rarely with bisphosphonate therapy, mainly in patients receiving long-term treatment for osteoporosis.
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A patient alert card is being introduced for men taking finasteride to help raise awareness of the risk of psychiatric side effects and sexual dysfunction, including the potential for sexual dysfunction to persist after trea…
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Summary report on the risk of suicidal thoughts and behaviour related to antidepressants.
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Abacavir should be used in line with current treatment guidelines and with caution in patients with high cardiovascular risk factors.
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A summary of recent letters, medicine recalls and notifications sent to healthcare professionals
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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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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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Last month, letters were sent regarding SGLT2 inhibitors and Xgeva▼ (denosumab).
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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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In April 2016, letters were sent regarding canagliflozin (Invokana▼, Vokanamet▼), BCR-ABL tyrosine kinase inhibitors, pomalidomide (Imnovid▼), and retigabine (Trobalt)
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Indication restricted to nausea and vomiting, new contraindications, and reduced dose and duration of use.
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We want to remind healthcare professionals that use of systemic (oral and injectable) NSAIDs such as ibuprofen, naproxen, and diclofenac is contraindicated in the last trimester of pregnancy (after 28 weeks of pregnancy).
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Cases of severe hypersensitivity syndromes, sometimes fatal, have been reported with etravirine.
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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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A signal of increased lower limb amputation (primarily of the toe) in people taking canagliflozin compared with placebo in a clinical trial in high cardiovascular risk patients is currently under investigation.
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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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In March 2016, letters were sent regarding SGLT2 inhibitors, insulin lispro, natalizumab, noradrenaline, radium-223 dichloride, aflibercept and idelalisib.
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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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Five cases of necrotising fasciitis have been reported in patients treated with panitumumab in combination with chemotherapy.
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Incorrect dosage of bivalirudin in percutaneous coronary intervention can lead to major adverse cardiac events.
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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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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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Healthcare professionals reminded that tacrolimus may be associated with possible risk of malignancy.
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Updated contraindications and maximum dose recommendations when taken with a number of other medicines.
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Healthcare professionals should be aware of this risk when prescribing prasugrel.
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There is a risk of harmful drug interactions with the ritonavir component of the COVID-19 treatment Paxlovid▼ due to its inhibition of the enzyme CYP3A, which metabolises many commonly used drugs. Prescribers should obtain a…
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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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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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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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Initiate orlistat treatment only after careful consideration of the possible impact on efficacy of antiretroviral HIV medicines.
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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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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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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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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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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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Recent epidemiological evidence of an increased risk of fracture with long-term use of proton pump inhibitors (PPIs).…
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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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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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Letters were sent to healthcare professionals about Lartruvo▼ (olaratumab), quadrivalent influenza vaccine (split virion, inactivated), SGLT2 inhibitors, and carbimazole and thiamazole (synonym: methimazole)-containing products.…