MHRA Warnings Flashcards
1
Q
Alendronic Acid (Bisphosphonates) (3)
A
- Rare atypical femoral fractures 2. Osteonecrosis of the jaw 3. Osteonecrosis of the external auditory canal
2
Q
Isotretinoin (2) (Retinoid/ Roaccutane)
A
- Erectile dysfunction and decreased libido 2. Pregnancy Prevention Programme
3
Q
Warfarin (3)
A
- Direct acting antivirals to treat chronic hepatitis C- risk of interaction and changes to INR (descreases INR) 2. Monitoring of patients during COVID19 3. Calciphylaxis - painful skin rash - should stop taking
4
Q
Direct-acting Oral Anticoagulants Apixaban, Edoxaban, Dabigatran
A
- Increased risk of recurrent thrombotic events in patients with antiphospholipid syndrome 2. Reversal agent available = Andexanet Alfa (Ondexxya)
5
Q
Rivaroxaban
A
- 15mg and 20mg should be taken with food (due to lack of efficacy on empty stomach) Same as DOAC card
6
Q
Methotrexate NEVER EVNET
A
- Once weekly dosing for non cancer patients
7
Q
Ciprofloxacin (Fluoroquinolone antibiotics) (2)
A
- Small increased risk of aortic aneurysm and dissection 2. New restrictions and precautions for use due to very rare reports of disabling and potentially long-lasting or irreversible side effects Such as tendinitis or tendon rupture, muscle pain, muscle weakness, joint pain, joint swelling, peripheral neuropathy, and CNS effects, and to contact their doctor immediately. Also avoid concomitant use with corticosteroids as can exacerbate fluoroquinolone-induced tendinitis and tendon rupture. Fluoroquinolones should be prescribed with caution in patients older than 60 years and in patients with renal impairment or solid-organ transplants as they are at a higher risk of tendon injury.
8
Q
Sodium Valproate (2)
A
- Risk of suicidal thoughts and behaviour
- Pregnancy prevention programme & Annual Risk Acknowledgement Form
9
Q
Ulipristal Acetate (Esmya)
A
- Suspension of the licence due to risk of serious liver injury Reported in women using it treating symptoms of uterine fibroids
10
Q
Etonorgestrel (Nexplanon) (1)
A
- Contraceptive implants: new insertion site to reduce rare risk of neurovascular injury and implant migration
11
Q
Erythromycin (2)
A
- Caution required due to cardiac risks (should not be given to QT interval prolongation, arrhythmia, electrolyte imbalance)
- Drug interaction with rivaroxaban - increased risk of bleeding
12
Q
Stimulant laxatives (Bisacodyl, Senna, Sodium Picosulfate) (2)
A
- OTC packs smaller and with warning labels - to tackle overuse and abuse 2. New age restrictions -12 over
13
Q
Modafinil (2)
A
- Increased risk of congenital malformations if used during pregnancy
- Reduces contraceptive effectiveness - Modafinil should not be used during pregnancy and women of childbearing potential must use effective contraception during treatment and for 2 months after stopping modafinil.
14
Q
Buproprion (1) (To aid smoking cessation in combination with motivational support in nicotine-dependent patients)
A
- Risk of serotonin syndrome with use with other serotonergic drugs e.g. SSRIs
15
Q
Opioids (2)
A
- Risk of dependence and addiction (esp longer than 3 months use) 2. Benzodiazepines and opioids: reminder of risk of potentially fatal respiratory depression
16
Q
Fentanyl (2)
A
Both - respiratory depression 1. Transdermal fentanyl patches: life-threatening and fatal opioid toxicity from accidental exposure, particularly in children 2. Transdermal fentanyl patches for non-cancer pain: do not use in opioid-naive patients
17
Q
SGLT2 Inhibitors (4)
A
- Reports of Fournier’s gangrene (necrotising fasciitis of the genitalia or perineum) - stop SGLT2 & start treatment urgently - abx & surgical debridement
- Canagliflozin may increase the risk of lower-limb amputation (mainly toes) in patients with type 2 diabetes.
- Risk of diabetic ketoacidosis - test for raised ketones in pts with acidosis symptoms even if glucose levels are near normal
- SGLT2 inhibitor treatment should be interrupted in patients who are hospitalised for major surgical procedures or acute serious medical illnesses and ketone levels measured, preferably in blood rather than urine.
18
Q
Emollients (1)
A
- Risk of severe and fatal burns Build up in fabrics - paraffin containing and paraffin free emollients
19
Q
Insulins (4)
A
- Risk of hyperglyceamia from rapid pump battery depletion or unexpected shut down
- Risk of severe harm and death due to withdrawing insulin from pen devices
- NHS Never Event: Overdose of insulin due to abbreviations or incorrect device
- Risk of cutaneous amyloidosis at injection site
20
Q
Clozapine (2)
A
- Reminder of potentially fatal risk of intestinal obstruction, faecal impaction, and paralytic ileus 2. Monitoring blood concentrations for toxicity especially when: - Patient stops smoking or switches to e-cig - Concomitant meds may interact and increase clozapine levels - pt has pneumonia or serious infection - Reduced clozapine metabolism suspected
21
Q
Ondansetron (1)
A
- Small increased risk of oral clefts following use in the first 12 weeks of pregnancy - joint decision to be made based on benefit and risks
22
Q
Ingenol mebutate Gel (Actinic keratosis on face/body)
A
- Suspension of the licence due to risk of skin malignancy
23
Q
Linezolid (Oxazolidinone antimicrobial and reversible monoamine oxidase inhibitor) (3)
A
- Rare severe optic neuropathy especially with treatment longer than 28 days 2. Blood disorders reported - weekly FBC needed 3. Not active against Gram negative
24
Q
Pioglitazone (2)
A
- Increased risk of heart failure
- Small increase in risk of bladder cancer
25
Q
Thiamine (Vit B1)
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.
26
Q
Fingolimod (MS) (5)
A
- Not recommended for patients at known risk of cardiovascular risk - monitoring for those with bradycardia/heart block after the first dose and after treatment interruption 2. Can cause persistent bradycardia 3. Rebound effect after stopping/switching therapy 4. Has an immunosuppressive effect and can increase the risk of skin cancers and lymphoma 5. Increased risk of congenital malformations. Must use effective contraception during, and for 2 months after stopping treatment.
27
Q
PPIs (3)
A
- Increased risk of fracture with long term use
- Hypomagnesaemia with long term use - measure magnesium before treatment and periodically.
- Low risk of lupus
28
Q
Metoclopramide
A
- Risk of neurological adverse effects – restricted dose and duration Should only be short term (5 days) 10mg TDS max DAILY 500micrograms/kg
29
Q
Loperamide
A
- Cardiovascular risk associated with high doses - abuse or misuse Naloxone can be used as an antidote- may need repeated doses as loperamide duration of action longer than naloxone.
30
Q
Hyoscine Butylbromide (Buscopan)
A
- Risk of serious adverse effects in patients with underlying cardiac disease Hypotension Tachycardia Anaphylaxis
31
Q
Misoprostol (Mysodelle - vaginal delivery system) Termination of pregnancy
A
- Excessive uterine contractions (tachysystole) unresponsive to tocolytic treatment
32
Q
Tiotropium
A
- Risk of inhalation of capsule if placed in the mouthpiece of the inhaler 2. Pressurised metered dose inhalers (pMDI): risk of airway obstruction from aspiration of loose objects
33
Q
Quinine
A
- Dose-dependent QT-prolonging effects
34
Q
Pseudoephedrine
A
- Children under 6 years should not be given over-the-counter cough and cold medicines containing pseudoephedrine.
35
Q
Ciclosporin
A
- Must be prescribed and dispensed by brand name. Switching between formulations without close monitoring may lead to clinically important changes in blood-ciclosporin concentration.
36
Q
Tacrolimus
A
- Oral tacrolimus products: prescribe and dispense by brand name only, to minimise the risk of inadvertent switching between products, which has been associated with reports of toxicity and graft rejection Adoport, Prograf, Capexion, Tacni - immediate release caps BD Modigraf - granules BD Advagraf - prolonged release caps OD Envarsus® is not interchangeable with other oral tacrolimus
37
Q
Amphotericin (severe fungal infections)
A
- Liposomal and lipid-complex formulations: name change to reduce medication errors
38
Q
Direct-acting retrovirals to treat Hepatitis C (2)
A
- Interaction with vit K antagonists and INR changes 2. Risk of hepatitis B re-activation
39
Q
Dolutegravir (HIV) (1)
A
- Increased risk of neural tube defects Counsel women of child-bearing age on use of Dolutegravir
40
Q
Etonogestrel implant (1)
A
- New insertion site to reduce rare risk of neurovascular injury and implant migration Implants usually in the arm - Reports of migration to pulmonary artery.
41
Q
Mycophenolate mofetil (1)
A
- Contraception advice for male patients - although not indicated risk of malformation or miscarriage but it is genotoxic and risk cannot be fully excluded.
42
Q
Cetuximab (1)
A
- Epidermal growth factor receptor (EGFR) inhibitors: serious cases of keratitis and ulcerative keratitis (inflammation of cornea) Rare cases - corneal perforation and blindness. Refer if any symptoms of vision etc
