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