MHRA /BNF safety warnings Flashcards
From BNF 76
1
Q
MHRA warning with corticosteroid use?
A
Risk of serious chorioretinopathy with local and systemic corticosteroid administration
- chorioretinopathy is an eye disease causing visual impairment
- patients should report any blurred vision/visual disturbances with corticosteroid treatment via any route
- Consider referral to opthamologist if patient presents with vision problems
2
Q
MHRA warning with Solu-medrone (injectable methylprednisolone)?
A
Do not use in patient’s with cows milk allergy
- chance of serious allergic reaction including bronchospasm and anaphylaxis
3
Q
MHRA warning with SLGT2i (sodium-glucose co-transporter 2 inhibitors)?
A
Risk of diabetic ketoacidosis
- potentially life-threatening
- some cases was atypical presentation with moderately elevated blood glucose
- inform pts of signs and symptoms of DKA and advise to seek immediate medical attention if they occur
- do not start in patients with risk factors for DKA
- *should be suspended in hospital when patients are acutely ill until they are medically fit **
4
Q
MHRA warning with Canagliflozin?
A
Increased risk of lower-limb amputation
(also risk of DKA for all SGLT2 inhibitors)
- stop canagliflozin if pt develops a lower limb complication and monitor pts with risk factors
5
Q
MHRA warnings with Pioglitazone?
A
- Cardiovascular safety
- incidence of heart failure increased when pioglitazone used with insulin - Risk of bladder cancer
- if pts respond to treatment benefit outweighs risk
- assess pts for risk factors and review treatment after 3-6 months
- Pts should report any haematuria, dysuria or urinary urgency
6
Q
MHRA warning with insulin?
A
Never withdraw insulin from pen devices
- risk of fatal overdose
7
Q
Three MHRA warnings with bisphosphonates?
these also apply to denosumab
A
- Reports of atypical femoral fractures
- review treatment after 5 years
- patients should report any thigh, hip or groin pain - Osteonecrosis of the jaw
- risk greater with IV bisphosphonates
- patients should have dental check up before treatment, good oral hygiene and report any oral symptoms eg pain, non-healing sores etc - Osteonecrosis of external auditory canal
- consider if pts on bisphosphonates present with ear symptoms
- Risk factors inc steroids, chemo, cotton bud use and ear operations
- Pts should report ear pain, discharge from ear or ear infections
8
Q
MHRA warning with warfarin?
A
Reports of calciphylaxis
- patients should consult their doctor if they develop a painful skin rash
- risk factors inc. ESRF
9
Q
MHRA warning with adrenaline?
A
Adrenaline auto-injectors, updated from European review - patients should be prescribed 2 and should carry at all times
- esp patients with allergic asthma
- patients and carers should be trained to use devices and check expiry dates
10
Q
MHRA warning with gentamicin?
Nov 2017
A
Potential for histamine-related reactions with some batches
- monitor patients for histamine-related adverse reactions (eg cramps, HTN, tachycardia, dizziness etc)
- caution with drugs causing histamine release, children, severe renal imp
11
Q
MHRA warning with clozapine?
Oct 2017
A
Potentially fatal risk of intestinal obstruction, faecal impaction and paralytic ileus
- varying degrees of intestinal peristalsis
- seek immediate medical advice before taking clozapine if constipation develops
12
Q
Safety warning with flucloxacillin?
A
Risk of hepatic disorders
- cholestatic jaundice + hepatitis can occur rarely up to 2 months after treatment with flucloxacillin is stopped
- risk is increased in elderly pts/ if treatment lasts over 2 weeks
- do not use if history of hepatic dysfunction/jaundice
13
Q
Two safety warnings with quinolone antibiotics?
A
- May induce convulsions in patients with or without a history
- cautioned in conditions with seizures
- use with NSAIDs can increase risk of convulsions
- discontinue drug if neurological reactions - Tendon damage including rupture
- C/I in patients with history of tendon disorders
- risks aged over 60 or corticosteroid use
14
Q
Two safety warnings with linezolid?
A
- Optic neuropathy
- risk of severe optic neuropathy, treatment should not exceed 28 days
- patients should report signs of visual impairment and monitor visual function - Blood disorders
- haematopoietic disorders have been reported
- FBC weekly during treatment
- risk incr if treatment over 10 days, renal impairment, myelosuppression, other medicines that can cause blood disorders
15
Q
Safety advice with ketoconazole?
A
Oral ketoconazole should not be used for treatment of fungal infections
- risk of hepatotoxicity greater than benefit of treatment
16
Q
MHRA warning with quinine?
Nov 2017
A
Dose dependent QT-prolonging effects
- cautioned in AV block or risk factors for QT prolongation inc cardiac disease, electrolyte disturbances, elderly
17
Q
MHRA warnings with antivirals used to treat Hep C?
eg, sofosbuvir, daclatasvir etc
A
- Interactions with vit K antagonists and changes to INR
- can reduce efficacy of vit K antagonists, monitor INR - Risk of Hep B reactivation
- screen patients for hep B before treatment
18
Q
MHRA warning with domperidone?
A
Risk of cardiac side effects
- should only be used for relief of N+V
- lowest dose for shortest duration (usually not over 1 week)
- C/I in conditions where cardiac conduction can be impaired
- does not apply to palliative care (unlicensed)
19
Q
MHRA warning with metoclopramide?
A
Risk of neurological adverse effects
- can cause extrapyramidal disorders and tardive dyskinesia
- Only 18+, 5 days treatment (short term only)
- Usually 10mg TDS, max dose 500mcg/kg
- only used for prevention of nausea or symptomatic treatment ie, in acute migraine
20
Q
MHRA warning with codeine?
A
Resticted use in children due to reports of morphine toxicity
- should only be used to relieve pain in children over 12 who have not responded to other painkillers such as ibuprofen or paracetamol
- for children 12-18, max 240mg/day for 3 days
- not recommended in children with compromised breathing
- should not be used in breast feeding
- C/I in all children <18 who undergo removal of tonsils/adenoids for sleep apnoea
21
Q
MHRA warning with dihydrocodeine?
Co-drydamol
Jan 2018
A
Prescribe and dispense by strength to avoid dispensing errors and accidental opioid overdose
- tablet strength and dose must be clearly indicated
22
Q
MHRA warning with eluxadoline?
A
Risk of pancreatitis
- Do not use in patients with cholecysectomy or biliary disorders
- Specialist use for IBS only
23
Q
MHRA warning with loperamide?
A
Risk of serious cardiac adverse effects with high doses
- Serious events such as cardiac arrest, QT prolongation and torsades de point reported in large overdoses
- Naloxone can be given as an antidote
- Pharmacists should remind pts not to take more than the recommended dose
24
Q
MHRA warning with PPIs?
A
Very low risk of subacute cutaneous lupus eythematosus
- If pt on PPI develops lesions + arthralgia in sun exposed areas consider SCLE and consider withdrawl of PPI
25
MHRA warning with hyoscine butylbromide?
Risk of serious adverse effects in patients with underlying cardiac disease
- Can cause tachycardia, hypotension + anaphylaxis
- C/I in tachycardia, cautioned in cardiac disease
- Monitor patients and have resuscitation equipment ready
26
MHRA warning with varenicline?
Suicidal behaviour and varenicline
- discontinue treatment and seek urgent medical attention if depressed mood/suicidal thoughts
- Patients with a history of psychiatric illness should be monitored closely (cautioned)
27
MHRA warning with hydroxyzine?
Risk of QT prolongation and torsades de pointes
- C/I in patients with history of prolonged QT or risk factors eg, cardiovascular disease, family history of sudden death, other QT prolonging drugs, low K+ or Mg2+, bradycardia
- Use for shortest time possible, max daily dose 100mg
- Avoid in elderly if possible, max daily dose 50mg
28
MHRA warning with apremilast?
Risk of suicidal thoughts and behaviours
| used in psoriatic arthritis
29
MHRA warning with hydrochlorothiazide?
Risk of non-melanoma skin cancer esp in long term use
- cumulative dose-dependent risk
- pts should check for and report and new/changed skin lesions or moles
- limit UV exposure and use protection
30
MHRA warning with febuxostat?
Risk of severe hypersensitivity reactions
- Including Stevens-Johnson syndrome + anaphylaxis
- Usually occurs in first month of tx
- Advise pts of signs of severe hypersensitivity
31
MHRA warning with finasteride?
Rare reports of depression and suicidal thoughts
| - If this occurs stop treatment and inform a healthcare professional
32
MHRA warnings with Epoetins?
| SCARs - Jan 2018
1. V rare risk of severe cutaneous adverse reactions
Including SJS, potentially fatal. Patients should seek medical attention for widespread rash and blistering
2. Haemoglobin conc
Overcorrection of Hb conc in CKD can increase risk of death and serious CV events
3. Tumour progression and excess mortality in patients with cancer
Licensed only for patients having chemotherapy, need risk vs benefit assessment
33
MHRA warning with parenteral iron?
Risk of serious hypersensitivity reactions
- Can cause fatal anaphylaxis
- Take caution with every dose, reactions can occur when previous dose was tolerated, test doses not recommended
- Monitor patient for 30 mins after dose, have suitably trained staff and resuscitation facilities available
- High risk in patients with known allergies
- Avoid in pregnancy especially the first trimester
34
MHRA warning with mycophenolate mofetil?
| Feb 2018
Contraception advice for male patients
- Genotoxic so risk of malformations/misscarriage in preganancies where the father was taking MMF can not be excluded
- Male patients should use effective contraception throughout treatment and for 90 days after stopping
35
MHRA warning with sodium valproate?
| April 2018/19
C/I in women and girls unless conditions of pregnancy prevention programme are met
- Highly teratogenic, 30-40% chance of neurodevelopmental disorders and 10% of congenital malforms
- Must meet conditions of PPP, exclude pregnancy befoer treatment and use highly effective contraception
- New annual risk acknowledgment form to support compliance with PPP
36
MHRA warning with tiotropium (Braltus)?
| May 2018
Risk of inhalation of capsule if placed in mouthpiece of inhaler
- Inhaled caps cause coughing and risk of aspiration/airway obstruction
- Pharmacists should remind patients to never place capsule directly into mouthpiece
37
Medical device alert about accu-check blood glucose test strips?
May 2018
Accu-check aviva, performa + inform II
| - Risk of strip error messages and false glucose results
38
MHRA warning with Obeticholic acid? (Ocaliva)
| April 2018
Risk of serious liver injury in patients with pre-existing hepatic impairment
- Reminder to adjust dose according to liver function monitoring
- Risk of liver injury and death in pts with biliary cholangitis
- Assess hepatic status before treatment and evaluate need for dose reductions
39
MHRA warning with ulipristal (Esmya) for uterine fibroids?
| Aug 2018
Restrictions for use and requirement to check liver function before, during and after treatment
- Cases of liver injury including hepatic failure reported worldwide
- LFTs + liver monitoring should be carried out for all women treated with Esmya
- More than one treatment course only authorised in women not eligible for surgery
40
MHRA advice for use of head lice eradication products?
| March 2018
Risk of serious burns if treated hair is exposed to open flames or other sources of ignition
- Some products are combustible/flammable and can ignite and cause serious harm
- Should not smoke around treated hair
- Keep treated hair away from open flames/other sources of ignition including in the morning after overnight treatment until the hair is washed
41
MHRA warning for Misoprostol vaginal delivery system (Mysodelle)?
Feb 2018
Reports of excessive uterine contractions unresponsive to tocolytic treatment
- Excessive uterine tachysystole that may not respond to treatment
- Monitor patients and remove delivery system if excessive/prolonged contractions, onset of labour or clinical concern for mother or baby
42
MHRA warning for Cladribine for leukaemia?
| Dec 2017
Reports of progressive multifocal encephalopathy
- Stop treatment immediately if PML is suspected
- Consider PML for patients with new/worsening neurological symptoms
43
MHRA warnigns with fingolimod?
| April-Dec 2017
1. Multiple sclerosis, risk of rebound syndrome after stopping/switching therapy
2. Cardiac risk
Can cause persistent bradycardia, risk of arrythmias and heart block following the first dose
3. Immunosuppressive effect, can increase risk of skin cancer and lymphoma
Also risk of fatal fungal infections
44
MHRA warning with Gabapentin?
| Oct 2017 / Apr 2019
Risk of severe respiratory depression
- Can occur without concomitant opioid medicines
- Patients at risk inc elderly, use of other CNS depressants, reduced respiratory function, renal imp, neurological disease
Also rescheduling - risk of abuse and dependence, evaluate pts for a history of drug abuse
45
MHRA warning with isotretinoin?
| Oct 2017
Rare reports of erectile dysfunction and decreased libido
