MHRA warnings Flashcards by Eunice Leong

Clozapine

Clozapine + Antipsychotics - monitor blood toxicity
Clozapine potentially fatal risk of intestinal obstruction, faecal impaction and paralytic ileus

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Quinine

Dose-dependent QT-prolonging effects

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Erythromycin

Risk of infantile hypertrophic pyloric stenosis
Caution required due to cardiac risks (QT prolongation)
Drug interaction with rivaroxaban

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Loperamide

Serious cardiac adverse reactions with high doses

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Febuxostat

Increase risk of cardiovascular death and mortality in patients with history of major CVD
Serious hypersensitivity reactionsM

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Macrogol

PEG laxatives and starch-based thickeners - potential interaction leading to increase risk of aspiration

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PPI

Very low risk of subacute cutaneous lupuserythematosus

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Finasteride

Rare reports of depression and suicidal thoughts

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Aminoglycosides (e.g. gentamicin, amikacin, tobramycin)

Increase risk of deafness in pt with mitochondrial mutations
Potential for histamine-related drug reactions

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Hydrochlorothiazide

Risk of non-melanoma skin cancer, especially in long-term use

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Pioglitazone

Risk of CVD events
Risk of bladder cancer

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Montelukast

Risk of neuropsychiatric reactions

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Ulipristal acetate

Esmya 5mg - further restrictions due to risk of serious liver injury

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Etonogestrel

Nexplanon implants - new insertion site to reduce rare risk of neurovascular injury and implant migration

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Beclomethasone

Qvar and Clenil Modulite not interchangable, prescribe by brand name

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Quinolones

Systemic and inhaled fluoroquinolones - small risk of heart valve regurgitation, aortic aneurysm and dissection
Risk of suicidal thoughts and behaviour
Fluoroquinolones can only be prescribed when other commonly recommended antibiotics are inappropriate
New restriction due to disabling and potentially long-lasting or irreversible side effects - tendon damage (especially with corticosteroid use), convulsions (especially with NSAIDS)

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Biphosphonates

Atypical femoral fractures
Osteonecrosis of the jaw
Osteonecrosis of external auditory canal

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Denosumab

Xgeva for giant cell tumour of bone - risk of hypercalcaemia following discontinuation
Xgeva for advanced bone malignancies - more frequent than zoledronic acid
Prolia - increase risk of multiple vertebral fractures after stopping or delaying ongoing treatment
Prolia - should not be used in patient under 18 yrs due to risk of hypercalcaemia

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Domperidone

Not for <12 yrs or <35kg weight
Lack of efficacy in children, contraindications in adults and adolescents

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Ondansetron

Small increase risk of oral clefts following use in first 12 weeks of pregnancy

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Levothyroxine

Brand prescribing - be aware when switching between products

Insulin

Never Event - abbreviations / incorrect device
Risk of cutaneous amyloidosis at injection site
Risk of harm and death due to withdrawing insulin from pens

Warfarin

Reports of calciphylaxis

Amiodarone

Risk of treatment + need for patient monitoring and supervision - reactions affecting eyes, heart, lungs, liver, thyroid gland, skin, peripheral nervous system that persist a month or longer after stopping treatment
Avoid use with sofosbuvir with daclatasvir;sofosbuvir and ledipasvir;simeprevir wiht sofosbuvir - risk of bradycardia and heartblock

Flucloxacillin

Hepatic disorders - cholestatic jaundice, hepatitis

Potassium permanganate

Risk of death or serious harm from accidental ingestion

Gabapentin

Risk of severe respiratory depression

Pregabalin

Reports of severe respiratory depression Risk during pregnancy - congenital malformations especially in 1st trimester Risk of abuse and dependance (Antiepileptics) Risk of suicidal thoughts (Antiepileptics) Switching between manufacturers

IUD

Uterine perforation

Tacrolimus

Brand only! Switching brands reports of toxicity and graft rejection

Amphotericin B

Liposomal and lipid - complex formulations not same

IV iron

Serious hypersensitivity reactions with IV iron

Ciclosporin

Brand only!

Hydroxyzine

Risk of QT prolongation

Corticosteroids (local+systemic)

Central serous chorioretinopathy - report any blurred vison / see opthamologist

Isotretinoin

Oral retinoid not in pregnancy Reports of erectile dysfunction and decreased libido

Chlorphenamine

Not for under <6 years

Canagliflozin

Increase risk of lower limb amputation

SGLT2 inhibitors

Risk of DKA Monitor ketones in blood during treatment interruption for surgical procedures or acute serious medical illness Reports of Fournier's gangrene (necrotising fascitis of genitalia/perineum)

Carbimazole

Acute pancreatitis Increase risk of congenital malformations - advice at least 2 method of contraception Neutropenia + agranulocytosis

Codeine

Not for children - morphine toxicity

Opioids

Risk of potentially fatal respiratory depression Risk of dependence and addiction

Valproate

Contraindicated in women + girls of childbearing potential unless met PPP requirements

pMDI

Risk of airway obstruction from aspiration of loose objects

Metoclopramide

Risk of neurological adverse effects - minimum dose shortest duration recommended

Topiramate

Risk of neurodevelopmental disabilities in children with prenatal exposure

Linezolid

Optic neuropathy Blood disorders

SSRI

Small increase risk of postpartum haemorrhage when used in the month before delivery

Hydroxychloroquine / Chloroquine

Increase risk of CVD when use with macrolide antibiotics Reports of psychiatric reactions

DOAC

Increase risk of recurrent thrombotic events in pt with antiphospholipid syndrome Reminder of bleeding risk, availability of reversal agents