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
Beclometasone inhalers
prescribe by brand- Qvar (extra fine particles) is twice as potent as clenil modulite
26
Beclometasone with formoterol (trimbow)
fostair (extra fine particles) more potent than trimbow- dose may need to be adjusted when switching
27
Montelukast
be alert for neuropsychiatric reactions- esp speech impairment/ OCD symptoms in young people and adolescents -check risk/benefit if this occurs
28
Chlorphenamine maleate
Children under 6 should not be given cough/ cold mixtures containing this drug OTC
29
Hydroxyzine
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
30
Promethazine
Children under 6 should not be given cough/ cold mixtures containing this drug OTC
31
Desensitising vaccines (e.g. bee venom/ grass pollen/ dust mite extract etc)
Should only be used by specialists for licensed indications - take particular care if they have asthma
32
Ivacaftor
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
33
Pholcodine
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
34
Pirfenidone
drug induced liver injury- monitor liver function and advise patients on signs of liver injury (esp if taking CYP inhibitors)
35
Gabapentin
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
Phenytoin injection
injectable phenytoin is error prone- make all staff aware of appropriate guidance relating to this
37
Pregabalin
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
Sodium valproate and Valproic acid
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
Benzos in status epilepticus
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
Midazolam
do not use any other than 1mg/ml preparation ensure flumazenil is available when midazolam is used IV to reverse effects if neccessary
41
Benzodiazepines with opioids
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
SSRIs and SNRIs, Vortioxetine
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
Haloperidol
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
Sulpride, Amisulpride, Olanzapine, Quetiapine, Risperidone
If toxicity is suggested blood levels can be checked
45
Zuclopenthiuoxol
Dont confuse depot and acute injectables
46
Aripiprazole
7.5mg/ml= acute, 400mg= depot monitor blood concs if toxicity appears
47
Clozapine
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
Co-beneldopa, co-careldopa, Apomorphine, Pramipexole, Ropinirole , Rotigotine
impulse control disorders- gambling/ binge eating/ hyper sexuality - inform of risk
49
Bromocriptine, Cabergoline
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
Domperidone
No longer indicated for nausea and vomitting in under 12s or weighing less than 35kg Do not exceed 1 weeks treatment
51
Metoclopramide
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
Ondansetron in pregnancy
1st trimester- increased risk of cleft palate - counsel
53
Hyoscine hydrobromide (premedication for anaesthesia)
Antimuscarinic- should only be administered in staff trained for this use
54
Methoxyflurane
self administered only under experienced staff, using hand held penthox inhaler
55
Opiods
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
Buprenorphine
Should prescribe by brand as 72h/ 96h/ 7 day patches available
57
Codeine
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
59
Co-dydramol
prescribed and dispensed by strength to avoid accidental opiod overdose
60
Fentanyl patches
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
Morphine, oxycodone, tramadol
Do not confuse 12hly and 24hly MR tabs
62
Tapentadol
can induce seizures or serotonin syndrome (esp if with antidepressants and antipsychotics
63
Modafinil
- 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
Bupropion
serotonin syndrome esp when with other seratonergic drugs
65
Methadone
some preparations are for addiction, others for pain relief
66
Aminoglycosides
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
Amikacin, Amphotericin B
serious harm and fatal overdoses from confusion between liposomal, pegylate, conventional forms- NOT INTERCHANGEABLE
68
Gentamicin
some batches contain high levels of histamine (residual from manufacturing process)- monitor for adverse reactions
69
Streptomycin
Side effects increase significantly after cumulative dose of 100g - should only be exceeded in exceptional circumstances
70
Erythromycin
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
Co-fluampici, flucloxacillin
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
Quinolones
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
Co-trimoxazole
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
Linezolid
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
Flucytosine
DPD deficiency- risk of fatal toxicity - contraindicated in full deficiency, caution with partial
76
Chloroquine
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
Quinine
Dose-dependent QT interval prolongation - caution in AV block and risk factors for QT interval prolongation
78
Molnupiravir, nirmatrlvir, ritonavir , remdesivir
Preg safety not established Report anyone having a baby to UKTIS
79
Elbasivir with grazoprevir/ Sofosbuvir (chronic hep C treatment)
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
Glecaprevir with Pibrentasvir
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
Dolutegravir
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
Genvoya (elvitegravir with cobistat, emtricitabine and tenofovir), or other HIV treatments boosted with cobistat
mean exposure is lower in second and third trimesters than post partum- can cause HIV to pass to baby
83
Bisphosphonates
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
Denosumab
- 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