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Summary report on the risk of suicidal thoughts and behaviour related to antidepressants.…
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Antiepileptic treatment is associated with a small risk of suicidal thoughts and behaviour.…
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…or suicide attempts.…
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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 worsen.…
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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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Avoid use in patients with previous or existing psychiatric symptoms and discontinue treatment if new or worsening psychiatric symptoms occur.
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The study found no clear evidence that varenicline was associated with an increased risk of fatal or non-fatal self-harm.
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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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…Assess patients for these risks before the start of treatment with belimumab and advise them to promptly seek medical attention if they develop new or worsening depression, suicidal ideation or thoughts about injuring themselves.…
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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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Risk of early psychiatric side-effects is one of several important safety issues for healthcare professionals to discuss with patients and carers, who should seek urgent medical advice in the event of any worrying symptoms.
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Healthcare professionals prescribing aripiprazole are reminded to be alert to the risk of addictive gambling and other impulse control disorders. Healthcare professionals should advise patients, their families and friends to…
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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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Warn patients and family, monitor patients for signs of depression
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Cases of sexual dysfunction, predominantly involving erectile dysfunction and decreased libido, have been reported rarely in patients taking oral isotretinoin for severe acne.
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How MHRA monitors the impact of regulatory action taken.
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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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We remind healthcare professionals that isotretinoin should only be used for severe forms of acne resistant to adequate courses of standard therapy with systemic antibacterials and topical therapy. Prescription of isotretino…
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Healthcare professionals prescribing montelukast should be alert to the risk of neuropsychiatric reactions in all patients including children and adolescents. Reported neuropsychiatric reactions include sleep disorders, hall…
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Updated guidance to use methylphenidateto safely and effectively for attention deficit hyperactivity disorder (ADHD) in children of 6 years or older and adolescents.
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New prescriber checklists, patient reminder cards, and pharmacy checklists are available to support the Pregnancy Prevention Programme in women taking acitretin, alitretinoin, and isotretinoin. Advice about the risk of neuro…
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Further information is available to support safer use
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Letters were sent about Xeljanz▼ (tofacitinib), ranitidine, Nulojix (belatacept), fluoroquinolone antibiotics, Genvoya▼, Stribild▼, Tybost, and belimumab (Benlysta▼). Drug alerts were issued about Accord losartan potassium c…
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Carefully consider the benefits and risks before prescribing systemic azithromycin or other systemic macrolide antibiotics (erythromycin or clarithromycin) to patients being treated with hydroxychloroquine or chloroquine. An…
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A summary of letters and drug alerts recently sent to healthcare professionals.
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Prescribers should be alert for neuropsychiatric reactions in patients taking montelukast and carefully consider the benefits and risks of continuing treatment if they occur.
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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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Systemic fluoroquinolones must now only be prescribed when other commonly recommended antibiotics are inappropriate. This follows a review by the MHRA which looked at the effectiveness of current measures to reduce the ident…
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Monitoring for encephalitis should continue for 12 months following discontinuation of daclizumab. Inform all patients who have discontinued daclizumab and their caregivers of the common symptoms of encephalitis and the need…
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The Isotretinoin Expert Working Group of the Commission on Human Medicines has made recommendations to strengthen the safety of isotretinoin treatment. Recommendations include new warnings, the need for consistent monitoring…