MHRA warnings Flashcards
Alendronic acid (3)
Rare atypical femur fracture; osteonecrosis of jaw; osteonecrosis of external auditory canal
Isotretinoin (2)
Erectile dysfunction and decreased libido; Pregnancy prevention program
Warfarin (2)
Interaction with anti-retroviral drugs for Hep C; Calciphylaxis
Apixaban, Edoxaban, Dabigatran (1)
Increased risk of recurrent thrombotic events in patients with phospholipid syndrome
Rivaroxaban (2)
Increased risk of recurrent thrombotic events in patients with phospholipid syndrome; Take with food (low efficacy on empty stomach)
Methotrexate NEVER EVENT
Overdose of methotrexate for non-cancer patients - WEEKLY
Quinolones (4)
Increased risk of tendon damage and rupture, especially if given together with steroids.
Small increased risk of aortic aneurysm and dissection.
New restrictions and precautions for use due to very rare reports of disabling and potentially long-lasting or irreversible side effects
Increased risk of convulsions especially in patients with seizure history. More risk if given together with NSAIDs.
Sodium Valproate (1)
PPP and updated Annual Risk Acknowledgement Form
Pregabalin (1)
Change of schedule due to abuse potential - Schedule 3, but exempt from safe custody.
Gabapentin (2)
Risk of severe respiratory depression; Change of schedule due to abuse potential - Schedule 3, but exempt from safe custody.
Fentanyl patch (1)
Life-threatening and fatal opioid toxicity due to accidental exposure, especially in children
Clozapine (1)
Potentially fatal severe intestinal obstruction, faecal impaction and paralytic ileus
Carbimazole (3)
Increased risk of congenital malformations; Risk of acute pancreatitis, risk of bone marrow suppression
Codeine (2)f
Analgesia: restricted use in children due to reports of morphine toxicity (children over 12 only); Restricted use in children under 12 for cough and cold.
Hydrocortisone (2)
Rare risk of central serous chorioretinopathy with local as well as systemic administration; Muco-adhesive buccal tablets: should not be used off-label for adrenal insufficiency in children due to serious risks
All steroids (1)
Rare risk of central serous chorioretinopathy with local as well as systemic administration
Methylprednisolone (2)
Rare risk of central serous chorioretinopathy with local as well as systemic administration; Do not use injectable methylprednisolone in patients with cow`s milk allergy (contains lactose)
pMDIs (1)
Risk of airway obstruction from aspiration of loose objects
Beclometasone (2)
Rare risk of central serous chorioretinopathy with local as well as systemic administration; Qvar and Clenil are NOT interchangeable due to different particle size
Gentamicin (1)
Potential for histamine-related adverse drug reactions with some batches (November 2017)
Linezolid (2)
Rare severe optic neuropathy especially with treatment longer than 28 days; Blood disorders reported - weekly FBC needed
Adrenaline (2)
2 adrenaline pens to be prescribed and carried at all times; Activation failure with Emerade
Insulin NEVER EVENT + safety alert
Incorrect dosing due to abbreviations; Risk of severe harm and death due to withdrawing insulin from pen devices
Pioglitazone (2)
Increased risk of heart failure; small increase in risk of bladder cancer
Sodium-glucose co-transporter 2 (SGLT2) inhibitors (canagliflozin, dapagliflozin or empagliflozin) (2)
+ Canagliflozin (1)
Risk of diabetic ketoacidosis; Reports of Fournier’s gangrene (necrotising fasciitis of the genitalia or perineum)
Canagliflozin - increased risk of lower limb amputation, esp toes - foot care essential. Discontinue if any ulcers.
Thiamine (1)
Even though anaphylaxis can occur, it should not preclude IV admin in patients at risk of Wernicke-Korsakoff`s, infuse over 30 min and facilities for managing anaphylaxis.
Fingolimod (4)
Contraindications due to cardiac risks;
Multiple sclerosis therapies: signal of rebound effect after stopping or switching therapy;
Increased risk of cancer and serious skin infections; Increased risk of congenital malformations
PPIs (1)
Very low risk of subacute cutaneous lupus erythematosus
Metoclopramide (1)
Risk of neurological adverse effects—restricted dose and duration of use (EPSEs)
Loperamide (1)
Reports of serious cardiac adverse reactions with high doses of loperamide associated with abuse or misuse
Domperidone (1)
Risk of cardiac side-effects - short term use at lowest effective dose
Hyoscine Butylbromide (1)
Injection(Buscopan): risk of serious adverse effects in patients with underlying cardiac disease
Head lice eradication products (1)
Risk of serious burns if treated hair is exposed to open flames or other sources of ignition
Misoprostol (1)
Vaginal delivery system: reports of excessive uterine contractions (tachysystole) unresponsive to tocolytic treatment
Montelukast (1)
Risk of neuropsychiatric reactions
Tiotropium (2)
MDI risks; Risk of inhalation of capsule if placed in the mouthpiece of the inhaler
Varenicline (1)
Depressed mood and suicidal thoughts
Quinine (1)
Dose-dependent QT prolongation
Pseudoephedrine, ephedrine, guafenesine, promethazine, chlorphenamine, pholcodeine, diphenhydramine (1)
Do not give OTC cough-and-cold meds that contain these for children under 6
Ciclosporin (1)
Must be prescribed and dispensed by brand
Tacrolimus (1)
Prescribe by brand only - brand switch associated with toxicity and graft rejection
Amphotericin (1)
Parenteral amphotericin B: reminder of risk of potentially fatal adverse reaction if formulations confused (non lipid-based vs lipid-based)
Direct-acting retrovirals to treat Hepatitis C (3)
Interaction with vit K antagonists and INR changes; Risk of hepatitis B re-activation;
Glucose metabolism affected - can cause hypos, adjust diabetic drugs
Dolutegravir (1)
Neural tube defects in babies - avoid in pregnancy
Etonogestrel implant (1)
Reports of implant reaching the lungs
Mycophenolate mofetil (1)
Contraception for both males and females advised - teratogenic
Cetuximab (1)
Serious cases of keratitis and ulcerative keratitis
Amiodarone (1)
Severe bradycardia with sofosbuvir etc - avoid
Hydrochlorothiazide (1)
Melanoma skin cancer risk - patients to report any skin lesions
Simvastatin (1)
Avoid high-dose therapy due to increased risk of myopathy
Hydroxyzine (1)
QT prolongation and TdP
Anti-epileptics (2)
Switching and brand prescribing guidelines (3 Classes);
Small increased risk of suicidal thoughts
Bromocriptine, Cabergolide, Pergolide (1)
Fibrotic reactions in pericardium, pulmonary and retroperitoneal. Check valvular disease before initiation.
Dihydrocodeine+Paracetamol preparations
To be prescribed by strength
Tapentadol (1)
Can exacerbate seizures - caution in epilepsy and together with drugs that lower seizure threshold (antidepressants, antipsychotics). Reports of serotonin syndrome.
All Parkinsons disease meds (1)
Impulse control disorders.
Finasteride (1)
Reports of depression and suicidality
IUDs (1)
Risk of uterine perforation on insertion
Ulipristal (1)
Risk of acute liver injury when used for uterine fibroids treatment
All vaccines (1)
Reports of neonate deaths vaccinated after intra-uterine exposure to TNF-alpha inhibitors or immunosuppressants - defer scheduled vaccines
Yellow fever vaccine (1)
Avoid in thymus dysfunction; caution in >60yo - risk of severe adverse reactions
Ketoconazole (1)
No longer recommended for oral treatment of fungal infections due to significant risk of hepatotoxicity
Epoetins (3)
Risk of SCARS/SJS
Risk of Hb overload in CKD - risk of CVD, VTE and death
Reports of tumor progression and excess mortality in use of epoetins in malignancy
Iron injections (1)
Hypersensitivity reactions, even if 1st dose was normal. Test dose no longer recommended. Monitor for 30min after injection.
Latanoprost (1)
Reports of eye irritation since Xalatan reformulation - monitor and report.
Vinca alkaloids (1)
NEVER to be administered intrathecally
Febuxostat (1)
Risk of anaphylaxis and SJS
Piroxicam (1)
High risk of GI & skin SEs. Restricted use, max dose 20mg daily
All emollients (1)
Fatal burns, beware of residual emollients on clothes and bedding
Itraconazole (1)
Caution in patients at risk of HF
Darunavir with cobicistat (1)
Avoid in pregnancy due to risk of treatment failure and HIV transmission from mother to child