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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 …
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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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A summary of recent letters sent to relevant healthcare professionals, to inform them of updated safety information.
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Some patients may have exacerbation or rebound symptoms of rosacea. It is important to initiate treatment with a small amount of gel and increase the dose gradually, based on tolerability and treatment response.
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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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Cases of progressive multifocal leukoencephalopathy have been reported in patients taking dimethyl fumarate for multiple sclerosis, who all had prolonged lymphopenia.
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The immunomodulatory effects of fingolimod increase the risk of progressive multifocal leukoencephalopathy and opportunistic infections.
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Following an EU wide review of meprobamate, the remaining licence holder in the UK has ceased manufacturing and the licence will be cancelled by the end of 2016.
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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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In February 2016, a letter was sent to healthcare professionals regarding medicines containing valproate.
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Children exposed to valproate in utero are at high risk of developmental disorders and congenital malformations. Use the new communication materials below to discuss these risks with patients
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In December 2015, a letter was sent to healthcare professionals regarding Reminyl (galantamine hydrobromide).
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Proton pump inhibitors (PPIs) are associated with very infrequent cases of subacute cutaneous lupus erythematosus (SCLE), a non-scarring dermatosis that can develop in sun-exposed areas.
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New monitoring instructions to detect these side effects as soon as possible.
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Last month, letters were sent regarding ketoprofen gel, fingolimod (Gilenya▼) and efavirenz (Sustiva).
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The maximum adult daily dose of hydroxyzine is now 100 mg. Do not prescribe hydroxyzine to people with a prolonged QT interval or risk factors for QT interval prolongation.
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Check full blood counts before prescribing dimethyl fumarate and then every 6 to 12 months. Stop treatment immediately if you suspect progressive multifocal leukoencephalopathy.
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The new module helps clinicians understand how to identify, manage and avoid side effects when using corticosteroids.
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We remind you that a new offence will be enforced from 2 March 2015 in England and Wales. Talk to patients who are on medicines with potential to impair driving and discuss the patient leaflet advice.
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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 (Triomel),…
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Children exposed in utero to valproate are at a high risk of serious developmental disorders (in up to 30-40% of cases) and/or congenital malformations (in approximately 10% of cases).
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If you suspect exfoliative dermatitis caused by an adverse drug reaction to ustekinumab, stop treatment.
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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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Warn patients and family, monitor patients for signs of depression
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Reminder to test liver function before and during treatment.
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The new offence introduced in July does not apply in Northern Ireland nor replace any existing offences of driving.
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The Department for Transport has introduced a new offence of driving with certain controlled drugs above specified limits in the blood; this is likely to come into force on 2 March 2015.
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Risk of tuberculosis - screen all patients before starting treatment and monitor them closely.
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Cases of intraoperative floppy iris syndrome (IFIS) during cataract surgery have been reported in patients taking the atypical antipsychotics risperidone or paliperidone.
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Not for use in pregnancy unless there is no effective alternative.
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A recent review of the prescribing information has led to strengthened warnings and new measures to help minimise risks.
To minimise the risk of these adverse reactions, mefloquine must not be used for chemoprophylaxis in…
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The risk of foetal malformation with oral retinoids is extremely high, even when used at a low dose or for a short time during pregnancy. All oral retinoids have an associated Pregnancy Prevention Programme (PPP), which is s…
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Updated prescribing advice provided.
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May cause skin irritation, particularly in children with eczema, possibly due to sodium lauryl sulfate content.
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Liver function tests should be carried out at treatment initiation, during treatment, and also when the dose is increased.
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Levofloxacin (a fluoroquinolone antibiotic) is unfavourable as first-line treatment for several indications.
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Healthcare professionals reminded that tacrolimus may be associated with possible risk of malignancy.
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Concerns over recent years about the use of antipsychotics to treat the behavioural and psychological symptoms of dementia (BPSD).
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New maximum daily dose restrictions (including in elderly patients), contraindications, and warnings.
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Don't apply aqueous calamine cream onto the skin before an X-ray examination because it may affect the outcome of the radiograph.
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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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Risk of extrapyramidal effects or withdrawal symptoms (or both) in newborns after maternal use of antipsychotics during the third trimester of pregnancy.
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Supporting safer use
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Risks of Nicobrevin outweigh any benefits.
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Reminder to monitor and manage weight, glucose, and lipid levels.
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Differences in dose delivery between the pump device and dropper device for memantine.
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Erythema multiforme, Stevens Johnson syndrome and toxic epidermal necrolysis reported in association with isotretinoin - may result in hospitalisation, disability, life-threatening events, or death.
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Healthcare professionals should be aware of epidemiological data showing a small increased risk of fractures associated with the use of TCAs and SSRIs, and should take this risk into account in their discussions with patient…
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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…