MHRA drug safety update

Question 1

Important safety information about FLUCLOXACILLIN?

Answer 1

CHOLESTATIC JAUNDICE & HEPATITIS - can rarely occur Can occur up to 2 months after tx has stopped.

RISK FACTORS: Administration for more than 2-weeks and increasing age

Question 2

MHRA warning for BISPHOSPHONATES? (3)

Answer 2

1. ATYPICAL FEMORAL FRACTURES Report: thigh, hip, groin pain
2. OSTEONECROSIS OF JAW
   Zolendronate = highest risk = highest potency Report: dental issues
3. BENIGN IDIOPATHIC OSTEONECROSIS OF EXTERNAL AUDITORY CANAL Risk factors: >2y, steroids, infection, chemo, ear, cotton bud use Report: ear pain, discharge or infection

Question 3

MHRA warnings for WARFARIN?

Answer 3

Reports of Calciphylaxis: a rare painful syndrome of calcification of small BV located within fatty tissue and deeper layers of skin = blood clots/death

Question 4

Important safety information relating to quinolones: ciprofloxacin, levofloxacin, moxifloxacin, norfloxacin, ofloxacin

Answer 4

May induce CONVULSIONS in pts with/without history of convulsions. Taking NSAID’s at the same time may also induce them

TENDON DAMAGE: Including rupture has been reported rarely. May occur within 48hours of starting tx - cases reported several months after stopping tx. HCP are reminded: CI - pts with history of tendon disorders relating to quinolones use. Risk of tendon damage increased by concomitant use with corticosteroids.
If tendinitis suspected - discontinue immediately!!!

Question 5

MHRA/CHM advise on Quinine?

Answer 5

Dose-dependant QT-interval prolongation effects Use in caution in patients with risk factors for QT-prolongation or those with AV-block

Question 6

Warning related to the SGLT-2 inhibitors?

Answer 6

Risk of Atypical DKA
Risk of lower limb amputation (including toes)
Gangrene

Question 7

What is the MHRA/CHM warning for corticosteroids?

Answer 7

Central serous chorioretinopathy. Retinal disorder linked to systemic and local administration. MHRA recommends: pts to report any blurred vision or visual disturbances given by any route and referral to ophthalmologist for evaluation

Question 8

What is the CHMP advice for KETOCONAZOLE?

Answer 8

Risk of hepatotoxicity associated with PO ketoconazole is greater than the benefit in tx fungal infections

Drs should review those being tx and find alternatives. Pts with rxs for ketoconazole should be referred back to drs

PO ketoconazole for Cushing syndrome and topical products don’t apply to this!

Question 9

MHRA/CHM warning for hydroxyzine ??

Answer 9

Risk of QT-prolongation & tarsade de pointes

CI in QT prolongation or in those with risk factors for it.

Question 10

MHRA reports on antipsychotics with dementia in elderly?

Answer 10

Increased risk of stroke and Small increase risk of death

Question 11

MHRAs advise on anti-epileptics

Answer 11

They are all associated with a small increased risk of suicidal thoughts and behaviours l

Question 12

Safety information for itraconazole

Answer 12

REPORTS OF HEART FAILURE Caution when prescribing for patients at high risk of HF.
Those at risk include: receiving high doses/longer courses
older patients/those with cardiac disease
chronic lung disease (COPD) associated with pulmonary HTN
receiving treatment with NEGATIVE INOTROPIC DRUGS - CCB
Itraconazole should be avoided in pts with ventricular dysfunction/history of HF (unless the infection is serious)

Question 13

MHRA advise for thiamine VIT B1

Answer 13

Serious allergic adverse reactions - rarely occur - during/shortly after parenteral admin
should not preclude use - particularly for wernicke korsakoff syndromes
IV admin by infusion over 30 mins
facilities for anaphylaxis available (for resuscitation)

Question 14

Codeine phosphate warnings ?

Answer 14

CI in all children who have had tonsillectomy due to obstructive sleep apnoea

CI in ultra-rapid metaboliser CYP2D6

Not to be sold OTC to children under 12