MHRA warnings Flashcards

1
Q

Alendronic acid (3)

A

Rare atypical femur fracture; osteonecrosis of jaw; osteonecrosis of external auditory canal

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2
Q

Isotretinoin (2)

A

Erectile dysfunction and decreased libido; Pregnancy prevention program

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3
Q

Warfarin (2)

A

Interaction with anti-retroviral drugs for Hep C; Calciphylaxis

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4
Q

Apixaban, Edoxaban, Dabigatran (1)

A

Increased risk of recurrent thrombotic events in patients with phospholipid syndrome

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5
Q

Rivaroxaban (2)

A

Increased risk of recurrent thrombotic events in patients with phospholipid syndrome; Take with food (low efficacy on empty stomach)

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6
Q

Methotrexate NEVER EVENT

A

Overdose of methotrexate for non-cancer patients - WEEKLY

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7
Q

Quinolones (4)

A

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.

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8
Q

Sodium Valproate (1)

A

PPP and updated Annual Risk Acknowledgement Form

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9
Q

Pregabalin (1)

A

Change of schedule due to abuse potential - Schedule 3, but exempt from safe custody.

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10
Q

Gabapentin (2)

A

Risk of severe respiratory depression; Change of schedule due to abuse potential - Schedule 3, but exempt from safe custody.

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11
Q

Fentanyl patch (1)

A

Life-threatening and fatal opioid toxicity due to accidental exposure, especially in children

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12
Q

Clozapine (1)

A

Potentially fatal severe intestinal obstruction, faecal impaction and paralytic ileus

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13
Q

Carbimazole (3)

A

Increased risk of congenital malformations; Risk of acute pancreatitis, risk of bone marrow suppression

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14
Q

Codeine (2)f

A

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.

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15
Q

Hydrocortisone (2)

A

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

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16
Q

All steroids (1)

A

Rare risk of central serous chorioretinopathy with local as well as systemic administration

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17
Q

Methylprednisolone (2)

A

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)

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18
Q

pMDIs (1)

A

Risk of airway obstruction from aspiration of loose objects

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19
Q

Beclometasone (2)

A

Rare risk of central serous chorioretinopathy with local as well as systemic administration; Qvar and Clenil are NOT interchangeable due to different particle size

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20
Q

Gentamicin (1)

A

Potential for histamine-related adverse drug reactions with some batches (November 2017)

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21
Q

Linezolid (2)

A

Rare severe optic neuropathy especially with treatment longer than 28 days; Blood disorders reported - weekly FBC needed

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22
Q

Adrenaline (2)

A

2 adrenaline pens to be prescribed and carried at all times; Activation failure with Emerade

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23
Q

Insulin NEVER EVENT + safety alert

A

Incorrect dosing due to abbreviations; Risk of severe harm and death due to withdrawing insulin from pen devices

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24
Q

Pioglitazone (2)

A

Increased risk of heart failure; small increase in risk of bladder cancer

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25
Q

Sodium-glucose co-transporter 2 (SGLT2) inhibitors (canagliflozin, dapagliflozin or empagliflozin) (2)

+ Canagliflozin (1)

A

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.

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26
Q

Thiamine (1)

A

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.

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27
Q

Fingolimod (4)

A

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

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28
Q

PPIs (1)

A

Very low risk of subacute cutaneous lupus erythematosus

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29
Q

Metoclopramide (1)

A

Risk of neurological adverse effects—restricted dose and duration of use (EPSEs)

30
Q

Loperamide (1)

A

Reports of serious cardiac adverse reactions with high doses of loperamide associated with abuse or misuse

31
Q

Domperidone (1)

A

Risk of cardiac side-effects - short term use at lowest effective dose

32
Q

Hyoscine Butylbromide (1)

A

Injection(Buscopan): risk of serious adverse effects in patients with underlying cardiac disease

33
Q

Head lice eradication products (1)

A

Risk of serious burns if treated hair is exposed to open flames or other sources of ignition

34
Q

Misoprostol (1)

A

Vaginal delivery system: reports of excessive uterine contractions (tachysystole) unresponsive to tocolytic treatment

35
Q

Montelukast (1)

A

Risk of neuropsychiatric reactions

36
Q

Tiotropium (2)

A

MDI risks; Risk of inhalation of capsule if placed in the mouthpiece of the inhaler

37
Q

Varenicline (1)

A

Depressed mood and suicidal thoughts

38
Q

Quinine (1)

A

Dose-dependent QT prolongation

39
Q

Pseudoephedrine, ephedrine, guafenesine, promethazine, chlorphenamine, pholcodeine, diphenhydramine (1)

A

Do not give OTC cough-and-cold meds that contain these for children under 6

40
Q

Ciclosporin (1)

A

Must be prescribed and dispensed by brand

41
Q

Tacrolimus (1)

A

Prescribe by brand only - brand switch associated with toxicity and graft rejection

42
Q

Amphotericin (1)

A

Parenteral amphotericin B: reminder of risk of potentially fatal adverse reaction if formulations confused (non lipid-based vs lipid-based)

43
Q

Direct-acting retrovirals to treat Hepatitis C (3)

A

Interaction with vit K antagonists and INR changes; Risk of hepatitis B re-activation;
Glucose metabolism affected - can cause hypos, adjust diabetic drugs

44
Q

Dolutegravir (1)

A

Neural tube defects in babies - avoid in pregnancy

45
Q

Etonogestrel implant (1)

A

Reports of implant reaching the lungs

46
Q

Mycophenolate mofetil (1)

A

Contraception for both males and females advised - teratogenic

47
Q

Cetuximab (1)

A

Serious cases of keratitis and ulcerative keratitis

48
Q

Amiodarone (1)

A

Severe bradycardia with sofosbuvir etc - avoid

49
Q

Hydrochlorothiazide (1)

A

Melanoma skin cancer risk - patients to report any skin lesions

50
Q

Simvastatin (1)

A

Avoid high-dose therapy due to increased risk of myopathy

51
Q

Hydroxyzine (1)

A

QT prolongation and TdP

52
Q

Anti-epileptics (2)

A

Switching and brand prescribing guidelines (3 Classes);

Small increased risk of suicidal thoughts

53
Q

Bromocriptine, Cabergolide, Pergolide (1)

A

Fibrotic reactions in pericardium, pulmonary and retroperitoneal. Check valvular disease before initiation.

54
Q

Dihydrocodeine+Paracetamol preparations

A

To be prescribed by strength

55
Q

Tapentadol (1)

A

Can exacerbate seizures - caution in epilepsy and together with drugs that lower seizure threshold (antidepressants, antipsychotics). Reports of serotonin syndrome.

56
Q

All Parkinsons disease meds (1)

A

Impulse control disorders.

57
Q

Finasteride (1)

A

Reports of depression and suicidality

58
Q

IUDs (1)

A

Risk of uterine perforation on insertion

59
Q

Ulipristal (1)

A

Risk of acute liver injury when used for uterine fibroids treatment

60
Q

All vaccines (1)

A

Reports of neonate deaths vaccinated after intra-uterine exposure to TNF-alpha inhibitors or immunosuppressants - defer scheduled vaccines

61
Q

Yellow fever vaccine (1)

A

Avoid in thymus dysfunction; caution in >60yo - risk of severe adverse reactions

62
Q

Ketoconazole (1)

A

No longer recommended for oral treatment of fungal infections due to significant risk of hepatotoxicity

63
Q

Epoetins (3)

A

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

64
Q

Iron injections (1)

A

Hypersensitivity reactions, even if 1st dose was normal. Test dose no longer recommended. Monitor for 30min after injection.

65
Q

Latanoprost (1)

A

Reports of eye irritation since Xalatan reformulation - monitor and report.

66
Q

Vinca alkaloids (1)

A

NEVER to be administered intrathecally

67
Q

Febuxostat (1)

A

Risk of anaphylaxis and SJS

68
Q

Piroxicam (1)

A

High risk of GI & skin SEs. Restricted use, max dose 20mg daily

69
Q

All emollients (1)

A

Fatal burns, beware of residual emollients on clothes and bedding

70
Q

Itraconazole (1)

A

Caution in patients at risk of HF

71
Q

Darunavir with cobicistat (1)

A

Avoid in pregnancy due to risk of treatment failure and HIV transmission from mother to child