MHRA warnings Flashcards

all the MHRA warnings in the BNF baybee

1
Q

polyethylene glycols

A

do not mix with starch based thickeners = thin watery suspension that may cause aspiration

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2
Q

stimulant laxative (bisocodyl)

A

remember diet and lifestyle is first line - this should only be used if lifestyle & bulk-forming and osmotic laxatives have been tried
should not be given if under 12 or 12-17 unless under a doctors request

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3
Q

Senna, sodium picosulfate

A

try diet and lifestyle measures first & other laxatives
over 12s only

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4
Q

Loperamide

A

serious cardiovascular events (QT prolongation; torsade de pointes; heart attack) including fatalities have been reported and associated with large overdoses
naloxone- antidote (may need repeated doses) & monitor 48 h for CNS depression
DO NOT EXCEED DOSE

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5
Q

PPIs

A

SCLE can occur weeks/ months after exposure
lesions (esp in areas that get a lot of sunlight) + arthralgia = avoid sunlight in that area & probably withdraw med

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6
Q

Hyoscine butylbromide injection

A

tachycardia, hypotension, anaphylaxis- more likely in those with underlying coronary heart disease
C/Ied in cardiac tachycardia, caution in CHD
ensure resus is available

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7
Q

Obeticholic acid

A

serious liver injuries and deaths
ensure dose is adjusted or liver impairment

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8
Q

Naltrexone with bupropion

A

dizziness, somnolence, loss of consciousness, seizure
may affect ability to drive esp in early treatment

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9
Q

corticosteroids

A

-central serious chorioretinopathy
- steroid emergency card bc adrenal suppression
- rebound flares if topical - dermatitis w intense redness, stinging, burning which may spread further than initial area-> use lowest strength, shortest duration

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10
Q

amiodarone

A

avoid with sofosbuvir- bradycardia / heart block
serious adverse effects- eyes, heart, lung, liver, thyroid, skin, PNS- may continue a month or longer after discontinuation- ensure regular review & LFTs, TFTs checked
seek advice if worsening symptoms of pulmonary toxicity/ serious adverse events

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11
Q

sotalol

A

qt interval prolongation-> life threatening ventricular arrhythmia
avoid hypokalaemia (correct hypoK/ Mg before starting)
reduce dose/ stop if qt interval if over 550msecs

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12
Q

andexanet alfa

A

dont use anti factor Xa assay - these may cause an underestimate of reversal of apixaban - use clinical parameters
avoid before use of heparin as reverses effect

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13
Q

apixaban, rivaroxaban, dabigatran (5)

A

1) new contraindications- lesions and conditions that carry sig risk of major bleed; use of other anticoagulants alongside; consider renal function
2) Larger risk compared to warfarin on of repeat thrombotic events with patients with antiphospholipid syndrome
3) remain vigilant for bleeds & adjust dose for renal impairment
4) may interact with some antibacterials and antivirals
5) if switching from warfarin, ensure that warfarin is stopped before DOAC started

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14
Q

specific to rivaroxaban

A

take 15/ 20mg tabes WITH FOOD

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15
Q

Vitamin K antagonist

A

1) for those on direct acting antivirals for hep C, changes in the liver function necessitate close INR monitoring
2) acute illness may exaggerate effect of warfarin and require dose reduction- INR needed more often
3) notify health care provider if unwell/ loss of appetite/ vom/ diarrhoea
change in diet/ smoking status/ alcohol consumption/ new meds/ supplements/ cannot make it to INR appt

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16
Q

warfarin specifically

A

calciphylaxis- calcium accumulates in skin= painful rash (common in end-stage renal disease)

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17
Q

hydrochlorothiazide

A

prolonged use- dose cumulative increase in risk of non-melonoma skin cancer- advise them to check regularly and report any changes
use sun protection, limit direct sunlight
reconsider choice if they have had skin cancers in past

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18
Q

Riociguat

A

increased mortality and severe adverse effects in patients with pulmonary hypertension associated with idiopathic interstitial pneumonias- contraindicated in this group

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19
Q
A
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20
Q

noradrenaline/ norepinephrine

A

solution for infusion (0.08 and 0.16mg/ml) should not be diluted prior to use, and only be used for those established on noradrenaline therapy, where there dose is clinically proven to be escalating

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21
Q

adrenaline (3)

A

1) IV route should be used with extreme care by specialists only
2) give 2 autoinjectors- should be carried at all times- train on specific device, check expiration date regularly (can sign up for expiration alert services)
3) emerade 150s are discontinued
Use as soon as suspected allergic reaction occurs and call 999

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22
Q

tiotropium inhalers

braltus

A

ensure that capsules are stored in the screw bottle, not in the device itself, and check that the mouthpiece is clear before inhaling, never place the capsule in the mouthpiece- to avoid aspiration of capsule

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23
Q

salmeterol inhalers

A

LABAs should only be added if regular ICS are not controlling asthma sufficiently
should not be introduced if asthma is rapidly deteriorating
start low go slow
step back down to ICS when they have good long-term control

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24
Q

Inhaled corticosteroids

A

Central serious chorioretinopathy - report blurred vision/ other visual symptoms
steroid emergency card/ paediatric steroid emergency card

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25
Q

Beclometasone inhalers

A

prescribe by brand- Qvar (extra fine particles) is twice as potent as clenil modulite

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26
Q

Beclometasone with formoterol (trimbow)

A

fostair (extra fine particles) more potent than trimbow- dose may need to be adjusted when switching

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27
Q

Montelukast

A

be alert for neuropsychiatric reactions- esp speech impairment/ OCD symptoms in young people and adolescents -check risk/benefit if this occurs

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28
Q

Chlorphenamine maleate

A

Children under 6 should not be given cough/ cold mixtures containing this drug OTC

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29
Q

Hydroxyzine

A

small risk of QT interval prolongation& torsade de pointes
-> contraindicated if long QT or high risk of QT prolongation
-> max dose elderly= 50mg
-> max dose children < 40kg is 2mg/kg
use lowest effective dose

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30
Q

Promethazine

A

Children under 6 should not be given cough/ cold mixtures containing this drug OTC

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31
Q

Desensitising vaccines (e.g. bee venom/ grass pollen/ dust mite extract etc)

A

Should only be used by specialists for licensed indications - take particular care if they have asthma

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32
Q

Ivacaftor

A

risk of serious liver injury/ failure in those with cirrhosis or portal hypertension especially if taking kaftan with ivacaftor
-> check bilirubin, ALT and AST before treatment and every 3 mo during 1st year of tx, then annually (more often if they have liver disease) - caution
-> discontinue if significant changes in levels [ transaminases 5xULN/ transaminases are 3x ULN AND bilirubin is 2xULN] / live injury

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33
Q

Pholcodine

A

do not supply OTC to children under 6
if 6-12 can give after principles of best care have been tried - restricted to 5 days use

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34
Q

Pirfenidone

A

drug induced liver injury- monitor liver function and advise patients on signs of liver injury (esp if taking CYP inhibitors)

35
Q

Gabapentin

A

Levels of glycol, acesulfame K and saccharin may exceed WHO recommended limits if low body weight + high doses of rosemont brand suspension
Rare risk of severe respiratory depression (risk increases if taken with opiods/ compromised respiratory/ renal function elderly) - may require dose adjustment
Class C, Sch 3, excempt from safe custody requirements
Potentially fatal interaction with alcohol

36
Q

Phenytoin injection

A

injectable phenytoin is error prone- make all staff aware of appropriate guidance relating to this

37
Q

Pregabalin

A

Class C, Sch 3, exempt from safe custody
Potentially fatal interaction with alcohol
Slight increase risk of congenital malformations in first trimester - use effective contraception during treatment
Severe respiratory depression (esp. if respiratory/ renal/ neurological function impaired) - seek attention if you have trouble breathing

38
Q

Sodium valproate and Valproic acid

A

highly teratogenic (30-40% risk of neurodevelopment disorders, 10% risk of congenital malformation)- PPP (to be discussed with pt each collection) , only to be used in pregnant women if it is the only suitable drug
Dispense in whole packs wherever pos + warning label
Annual risk assessment form to be signed + review all WOCBP on this drug

39
Q

Benzos in status epilepticus

A

Should only be administered for anaesthesia by or under the direct supervision of personelle experienced in their use with adequate anaesthesia and airway management training

40
Q

Midazolam

A

do not use any other than 1mg/ml preparation
ensure flumazenil is available when midazolam is used IV to reverse effects if neccessary

41
Q

Benzodiazepines with opioids

A

When co-prescribed with opioids-> sedation, coma, death
Monitor for respiratory depression any time prescribing is changed
Methadone- resp depression may be delayed by up to 2 weeks

42
Q

SSRIs and SNRIs, Vortioxetine

A

increased risk of bleeding - effect on platelet function (e.g. postpartum haemorrhage if used 1 mo before delivery)- do not stop anticoagulants for high risk women but be aware of risk

43
Q

Haloperidol

A

ensure correct injection selected- dont confuse acute vs depot
Elderly patients are at higher risk of adverse neurological and cardiac effects
Before starting check baseline ECG and electrolytes should be corrected - check throughout tx
Monitor for EPSes
lowest pos dose for shortest duration pos

44
Q

Sulpride, Amisulpride, Olanzapine, Quetiapine, Risperidone

A

If toxicity is suggested blood levels can be checked

45
Q

Zuclopenthiuoxol

A

Dont confuse depot and acute injectables

46
Q

Aripiprazole

A

7.5mg/ml= acute, 400mg= depot
monitor blood concs if toxicity appears

47
Q

Clozapine

A

varying degrees of impairment of intestinal peristalsis - seek attention if constipation develops before you take the next dose
Blood concs checked if- stop/ start smoking or vaping; new interacting med; serious infection (e.g. pneumonia); reduced metabolism is suspected; toxicity suspected
Risk of agranulocytosis

48
Q

Co-beneldopa, co-careldopa, Apomorphine, Pramipexole, Ropinirole , Rotigotine

A

impulse control disorders- gambling/ binge eating/ hyper sexuality - inform of risk

49
Q

Bromocriptine, Cabergoline

A

Pulmonary, retro pulmonary, pericardial fibrotic reactions when used in PD or chronic endocrine disorders
- ECG before starting to rule out cardiac valvulopathy
- Erythrocyte sedimentation rate and serum creatinine+ chest Xray
- Monitor for dyspnoea, cough, chest pain, cardiac failure, abdominal tenderness, lung function tests

Impulse control disorders

50
Q

Domperidone

A

No longer indicated for nausea and vomitting in under 12s or weighing less than 35kg
Do not exceed 1 weeks treatment

51
Q

Metoclopramide

A

risk of neurological conditions (EPSes) and tardive dyskinesias outweigh benefit of longterm or high dose treatment
- adult- only for post-op/ radiotherapy/ migraine induced nausea and vomitting
- up to 5 days only
- IV slow bolus over 3 mins
- give liquid doses using oral syringe for accuracy

52
Q

Ondansetron in pregnancy

A

1st trimester- increased risk of cleft palate - counsel

53
Q

Hyoscine hydrobromide (premedication for anaesthesia)

A

Antimuscarinic- should only be administered in staff trained for this use

54
Q

Methoxyflurane

A

self administered only under experienced staff, using hand held penthox inhaler

55
Q

Opiods

A

monitor for sedation & respiratory depression esp with benzos
- prolonged use (over 3 mo)- inform about dependence/ tolerance; ensure you have a strategy to get them off the opioids eventually; council about unintended overdose (can be fatal); regularly monitor those with substance abuse disorders; slowly taper off at the end to avoid withdrawal effects; consider hyperalgesia if pain is not improving

56
Q

Buprenorphine

A

Should prescribe by brand as 72h/ 96h/ 7 day patches available

57
Q

Codeine

A

Should only be used to relieve acute moderate pain in over 12s if it cannot be relieved by paracetamol or ibuprofen
12-18 max dose should be 240mg
Interval no less than 6 h
duration 3d

Contraindicated if you have had your tonsils/ adenoids removed for sleep apnoea ; ultrarapid metabolisers; breast feeding; children whose breathing may be compromised

Signs of toxicity- reduced consciousness, lack of appetite, somolecence, constipation, pin-point pupils N&V

58
Q
A
59
Q

Co-dydramol

A

prescribed and dispensed by strength to avoid accidental opiod overdose

60
Q

Fentanyl patches

A

accidental exposure can occur if swallowed or transferred to another person
- do not exceed prescribed dose
- avoid touching adhesive side, wash hands after application
- do not cut patch
- avoid exposure to hot water/ air
- remove old patch before you apply the new one

  • may cause respiratory depression in opiod naive patients (CIed)
61
Q

Morphine, oxycodone, tramadol

A

Do not confuse 12hly and 24hly MR tabs

62
Q

Tapentadol

A

can induce seizures or serotonin syndrome (esp if with antidepressants and antipsychotics

63
Q

Modafinil

A
  • use during pregnancy increases risk of congenital malformations (heart defects, hypospadias, orofacial cleft) - should not be used during pregnancy
  • may reduce the effectiveness of contraceptive pills
64
Q

Bupropion

A

serotonin syndrome esp when with other seratonergic drugs

65
Q

Methadone

A

some preparations are for addiction, others for pain relief

66
Q

Aminoglycosides

A

Ototoxicity (more common if mitochondrial mutations- even when levels are in range) - urgent treatment should not be delayed
Monitor renal and auditory function continuously

67
Q

Amikacin, Amphotericin B

A

serious harm and fatal overdoses from confusion between liposomal, pegylate, conventional forms- NOT INTERCHANGEABLE

68
Q

Gentamicin

A

some batches contain high levels of histamine (residual from manufacturing process)- monitor for adverse reactions

69
Q

Streptomycin

A

Side effects increase significantly after cumulative dose of 100g - should only be exceeded in exceptional circumstances

70
Q

Erythromycin

A

Cardiotoxicity - QT interval prolongation- should not be given to long QT people/ ventricular arrythmias
Caution- cardiac disease and heart failure, bradycardia, other meds causing QT interval prolongation
rivaroxaban and erythromycin- interaction -> increased risk of bleed

Infant exposed- 2-3x higher risk of hypertrophic pyloric stenosis (esp in first 2 weeks of life) - seek attention if vomiting or irritability when feeding

71
Q

Co-fluampici, flucloxacillin

A

cholestatic jaundice up to 8 weeks after stopping-
- CIed in hx of hepatic dysfunction with flucloxacillin
- caution in hepatic impairment
- beta lactic cross sensitivity

72
Q

Quinolones

A

may induce convulsion (esp when taken with NSAIDs)
Tendon damage/ rupture within 48 h of starting- several months after stopping
(CIed in hx of rupture with quinolones, over 60 greater risk, corticosteroids increases risk, discontinue if tendonitis)
Aortic aneurysm and dissection- seek attain if severe abdominal/ chest/ back pain
Disabling, long-lasting, potentially irreversible SEs - stop at first signs of toxicity and seek attention and care in prescribing needed
Aortic valve regurgitation (esp if pre-existing heart valve issues, connective tissue disorders, hypertension, RA, infective endocarditis)

Seek attention if- rapid onset SOB, swelling in feet/ ankles/ abdomen, new onset palpitations

73
Q

Co-trimoxazole

A

should only be considered for acute exacerbations of chronic bronchitis and UTIs when there is bacteriological evidence of sensitivity and a good reason to prefer this over one agent alone

74
Q

Linezolid

A

Optic neuropathy when used >28 d
- report visual impairments/ new vis symptoms
- monitor regularly if over 28 d

Haematopoietic disorders
- FBC every week
- close monitoring if- 10-14 d +; myelosupression before starting; severe renal impairment; drugs interact to effect haemoglobin, blood count; platelet fx
- stop if myelosupression happens

75
Q

Flucytosine

A

DPD deficiency- risk of fatal toxicity - contraindicated in full deficiency, caution with partial

76
Q

Chloroquine

A

Occular toxicity- unlikely unless dose exceeds 4mg/kg/fday
Azithromycin + Chloroquine with RA-> increased risk of cardiovascular events and mortality
Suicidal ideation in first few months of treatment - seek attention

77
Q

Quinine

A

Dose-dependent QT interval prolongation - caution in AV block and risk factors for QT interval prolongation

78
Q

Molnupiravir, nirmatrlvir, ritonavir , remdesivir

A

Preg safety not established
Report anyone having a baby to UKTIS

79
Q

Elbasivir with grazoprevir/ Sofosbuvir (chronic hep C treatment)

A

may affect efficacy K antagonists - closely monitor INR
Screen patients for hep B before starting (can cause reactivation)
May cause hypos in diabetics- may need adjustment of diabetic meds - check glucose regularly esp in first 3 mo

80
Q

Glecaprevir with Pibrentasvir

A

Screen patients for hep B before starting (can cause reactivation)
May cause hypos in diabetics- may need adjustment of diabetic meds - check glucose regularly esp in first 3 mo

81
Q

Dolutegravir

A

risk of neural tube defects in babies born to mothers on this drug is lower than thought previously and is comparable to other HIV drugs

82
Q

Genvoya (elvitegravir with cobistat, emtricitabine and tenofovir), or other HIV treatments boosted with cobistat

A

mean exposure is lower in second and third trimesters than post partum- can cause HIV to pass to baby

83
Q

Bisphosphonates

A

atypical femoral fractures- reevaluate need esp after 5+ years of therapy
Report any thigh, hip, groin pain

Osteonecrosis of jaw - esp if IV/ zoledronate/ smokes/ history of dental diseases
- maintain good oral hygiene, report pain, swelling, mobility, non-healing sores, discharge
- if dentures- ensure they fit
- tell docs and dentists you are on this medication

Benign idiopathic osteonecrosis of external auditory canal - esp if over 2y tp
- consider this if chronic ear infections/ cholesteotoma
- high risk if chemotherapy/ steroids/ ear operations/ uses cotton buds/ infection
- report ear pain/ discharge / ear infection

84
Q

Denosumab

A
  • Atypical femoral fractures
  • multiple vertical fractures within 18 mo of discontinuation - re-evaluate need after 5 y
  • Osteonecrosis of jaw - patient reminder card- tell doc if there are issues with teeth before starting
  • osteonecrosis of external auditory canal
  • Hypocalcaemia - increases with renal impairment - usually in first few weeks
  • Rebound hypercalcaemia up to 9 months after discontinuation (not recommended for people while skeleton is still growing
  • increased rate of new malignancies compared to zoledronic acid

For cancer indication- have dental exam and work done before starting- do not start if there are unhealed lesions
look out for symptoms of hypocalcaemia- muscle cramps, spasms, twitches, numbness and tingling in toes fingers around mouth