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While this defect is still being investigated, we remind you to always have a full spare cylinder loaded on the delivery device so the cylinders can be switched without delay.
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Since November 2014, letters were sent regarding vismodegib (Erivedge ▼), chlorhexidine solutions, carbocisteine oral liquid (Mucodyne Paediatric 125mg/5ml), regadenoson (Rapiscan), a parenteral nutrition emulsion (Trio…
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Measure serum immunoglobulin levels if recurrent infections develop. Consider bronchiectasis or pulmonary fibrosis if patients develop persistent respiratory symptoms.
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A European review has considered MHRA evidence together with additional information from spontaneous reporting and published literature.
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We have received reports of Colobreathe (colistimethate sodium) capsules shattering when pierced by their inhaler device.
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From October 2014 Dexamethasone 4 mg/ml injection (Organon Laboratories Limited) will be replaced by Dexamethasone 3.8 mg/ml solution for injection (Aspen Pharma Trading Limited).
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New recommendations are being introduced to minimise the risk of serious hypersensitivity reactions with ferumoxytol.
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People now need to have a medical assessment before taking domperidone to determine if it is suitable for them due to the risk of cardiac side effects.
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We remind you to provide clear information to patients and caregivers regarding risk of accidental patch transfer and ingestion of patches, and need for appropriate disposal of patches.
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After every use, an ambulance should be called even if symptoms are improving, the individual should lie down with legs raised and, if at all possible, should not be left alone.
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Indication restricted to nausea and vomiting, new contraindications, and reduced dose and duration of use.
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Risk of tuberculosis - screen all patients before starting treatment and monitor them closely.
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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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Screening for hepatitis B virus is now recommended in all patients (not only those at risk of this infection) before starting treatment for all indications.
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Clarification of advice on new recommendations regarding initial test dose.
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Restricted dose and duration of use.
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All products to be named and prescribed as caffeine citrate.
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New strengthened recommendations to manage and minimise risk.
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Codeine should only be used to relieve acute moderate pain in children older than 12 years and only if it cannot be relieved by other painkillers such as paracetamol or ibuprofen alone.
Furthermore, a significant risk of se…
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Avoid use in patients with previous or existing psychiatric symptoms and discontinue treatment if new or worsening psychiatric symptoms occur.
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Safety review initiated following post-surgical fatalities in ultra-rapid metabolisers
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The Commission on Human Medicines recommend that existing levels of monitoring, education, and awareness measures by pharmacists should be maintained.
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Do not use in children aged 16 years or less, except in specialist settings under expert medical supervision.
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Healthcare professionals should advise patients and/or carers of the changes in the dose, packaging, dose dispenser and leaflet.
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Levofloxacin (a fluoroquinolone antibiotic) is unfavourable as first-line treatment for several indications.
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Care must be taken with dosing as the 2 products are not equivalent.
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Healthcare professionals should be aware that these capsules contain potential allergens.
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Reminder that paediatric paracetamol liquids had been developed to ensure children receive optimum dosing for their age.
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Studies of cardiovascular risk don’t support prescribing changes.
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Care needed when transferring from unlicensed formulations.
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Updated dosing for paediatric paracetamol liquids has been developed to ensure children receive the optimum dose for their age.
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Prescribers should be vigilant for possible thrombotic adverse reactions.
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Sitaxentan (Thelin▼) withdrawn due to hepatotoxicity.
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Safety studies of Spiriva Respimat▼
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Should not be used for cough under 18 years
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Benefits of these medicines used in conjunction with inhaled corticosteroids (ICS) in the control of asthma symptoms in children outweigh any apparent risks.
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Risk of psychological and behavioural side effects.
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Aluminium can be leached from glass after contact with calcium gluconate solution, leading to a risk of exposure to aluminium. Accumulation of aluminium might have adverse effects on bone mineralisation and neurological deve…
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European Medicines Agency has recommends the use of modafinil should be restricted to treat only sleepiness associated with narcolepsy - should no longer be used for obstructive sleep apnoea or chronic shift work sleep disor…
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Patients should be transferred to alternative bronchodilator therapy.
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Risk of accidental overdose, particularly in infants and neonates.
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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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Recent epidemiological evidence suggests a possible small increased risk of congenital cardiac defects in association with fluoxetine in early pregnancy, similar to that seen with paroxetine. There are insufficient data to d…
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A recent Europe-wide review of the safety information for alli has led to a number of updates, which bring the product information in line with that for Xenical.
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Extension of the indication for nicotine replacement therapy (NRT) to include harm reduction.
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Evidence indicates risks outweigh benefits.
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The design and content of the Patient Information Leaflets for methylphenidate products are being updated with the latest guidance on safe and effective use for patients and carers
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Patients who require a liquid oral formulation of a β-agonist should be switched to a more-selective short-acting β2-agonist such as salbutamol or terbutaline.
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If new movement disorders occur during treatment consider dose reduction or a gradual discontinuation of treatment in consultation with specialist advice.