MHRA Warnings

Question 1

Alendronic Acid (Bisphosphonates) (3)

Answer 1

1. Rare atypical femoral fractures 2. Osteonecrosis of the jaw 3. Osteonecrosis of the external auditory canal

Question 2

Isotretinoin (2) (Retinoid/ Roaccutane)

Answer 2

1. Erectile dysfunction and decreased libido 2. Pregnancy Prevention Programme

Question 3

Warfarin (3)

Answer 3

1. 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

Question 4

Direct-acting Oral Anticoagulants Apixaban, Edoxaban, Dabigatran

Answer 4

1. Increased risk of recurrent thrombotic events in patients with antiphospholipid syndrome 2. Reversal agent available = Andexanet Alfa (Ondexxya)

Question 5

Rivaroxaban

Answer 5

1. 15mg and 20mg should be taken with food (due to lack of efficacy on empty stomach) Same as DOAC card

Question 6

Methotrexate NEVER EVNET

Answer 6

1. Once weekly dosing for non cancer patients

Question 7

Ciprofloxacin (Fluoroquinolone antibiotics) (2)

Answer 7

1. 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.

Question 8

Sodium Valproate (2)

Answer 8

1. Risk of suicidal thoughts and behaviour
2. Pregnancy prevention programme & Annual Risk Acknowledgement Form

Question 9

Ulipristal Acetate (Esmya)

Answer 9

1. Suspension of the licence due to risk of serious liver injury Reported in women using it treating symptoms of uterine fibroids

Question 10

Etonorgestrel (Nexplanon) (1)

Answer 10

1. Contraceptive implants: new insertion site to reduce rare risk of neurovascular injury and implant migration

Question 11

Erythromycin (2)

Answer 11

1. Caution required due to cardiac risks (should not be given to QT interval prolongation, arrhythmia, electrolyte imbalance)
2. Drug interaction with rivaroxaban - increased risk of bleeding

Question 12

Stimulant laxatives (Bisacodyl, Senna, Sodium Picosulfate) (2)

Answer 12

1. OTC packs smaller and with warning labels - to tackle overuse and abuse 2. New age restrictions -12 over

Question 13

Modafinil (2)

Answer 13

1. Increased risk of congenital malformations if used during pregnancy
2. 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.

Question 14

Buproprion (1) (To aid smoking cessation in combination with motivational support in nicotine-dependent patients)

Answer 14

1. Risk of serotonin syndrome with use with other serotonergic drugs e.g. SSRIs

Question 15

Opioids (2)

Answer 15

1. Risk of dependence and addiction (esp longer than 3 months use) 2. Benzodiazepines and opioids: reminder of risk of potentially fatal respiratory depression

Question 16

Fentanyl (2)

Answer 16

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

Question 17

SGLT2 Inhibitors (4)

Answer 17

1. Reports of Fournier’s gangrene (necrotising fasciitis of the genitalia or perineum) - stop SGLT2 & start treatment urgently - abx & surgical debridement
2. Canagliflozin may increase the risk of lower-limb amputation (mainly toes) in patients with type 2 diabetes.
3. Risk of diabetic ketoacidosis - test for raised ketones in pts with acidosis symptoms even if glucose levels are near normal
4. 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.

Question 18

Emollients (1)

Answer 18

1. Risk of severe and fatal burns Build up in fabrics - paraffin containing and paraffin free emollients

Question 19

Insulins (4)

Answer 19

1. Risk of hyperglyceamia from rapid pump battery depletion or unexpected shut down
2. Risk of severe harm and death due to withdrawing insulin from pen devices
3. NHS Never Event: Overdose of insulin due to abbreviations or incorrect device
4. Risk of cutaneous amyloidosis at injection site

Question 20

Clozapine (2)

Answer 20

1. 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

Question 21

Ondansetron (1)

Answer 21

1. 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

Question 22

Ingenol mebutate Gel (Actinic keratosis on face/body)

Answer 22

1. Suspension of the licence due to risk of skin malignancy

Question 23

Linezolid (Oxazolidinone antimicrobial and reversible monoamine oxidase inhibitor) (3)

Answer 23

1. Rare severe optic neuropathy especially with treatment longer than 28 days 2. Blood disorders reported - weekly FBC needed 3. Not active against Gram negative

Question 24

Pioglitazone (2)

Answer 24

1. Increased risk of heart failure
2. Small increase in risk of bladder cancer

Question 25

Thiamine (Vit B1)

Answer 25

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.

Question 26

Fingolimod (MS) (5)

Answer 26

1. 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.

Question 27

PPIs (3)

Answer 27

1. Increased **risk of fracture** with long term use 2. **Hypomagnesaemia** with long term use - measure magnesium before treatment and periodically. 3. Low risk of **lupus**

Question 28

Metoclopramide

Answer 28

1. Risk of neurological adverse effects -- restricted dose and duration Should only be short term (5 days) 10mg TDS max DAILY 500micrograms/kg

Question 29

Loperamide

Answer 29

1. 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.

Question 30

Hyoscine Butylbromide (Buscopan)

Answer 30

1. Risk of serious adverse effects in patients with underlying cardiac disease Hypotension Tachycardia Anaphylaxis

Question 31

Misoprostol (Mysodelle - vaginal delivery system) Termination of pregnancy

Answer 31

1. Excessive uterine contractions (tachysystole) unresponsive to tocolytic treatment

Question 32

Tiotropium

Answer 32

1. 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

Question 33

Quinine

Answer 33

1. Dose-dependent QT-prolonging effects

Question 34

Pseudoephedrine

Answer 34

1. Children under 6 years should not be given over-the-counter cough and cold medicines containing pseudoephedrine.

Question 35

Ciclosporin

Answer 35

1. Must be prescribed and dispensed by brand name. Switching between formulations without close monitoring may lead to clinically important changes in blood-ciclosporin concentration.

Question 36

Tacrolimus

Answer 36

1. 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

Question 37

Amphotericin (severe fungal infections)

Answer 37

1. Liposomal and lipid-complex formulations: name change to reduce medication errors

Question 38

Direct-acting retrovirals to treat Hepatitis C (2)

Answer 38

1. Interaction with vit K antagonists and INR changes 2. Risk of hepatitis B re-activation

Question 39

Dolutegravir (HIV) (1)

Answer 39

1. Increased risk of neural tube defects Counsel women of child-bearing age on use of Dolutegravir

Question 40

Etonogestrel implant (1)

Answer 40

1. New insertion site to reduce rare risk of neurovascular injury and implant migration Implants usually in the arm - Reports of migration to pulmonary artery.

Question 41

Mycophenolate mofetil (1)

Answer 41

1. Contraception advice for male patients - although not indicated risk of malformation or miscarriage but it is genotoxic and risk cannot be fully excluded.

Question 42

Cetuximab (1)

Answer 42

1. 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