MHRA/CHM/CSM/CHMP/SAFETY⚠️

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
   IV bisphosphonates for Ca
   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

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 increase 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 SGLC2 class?

What extra warning is there about canagloflozin?

Answer 6

Risk of Atypical DKA

Canagliflozin also has risk if atypical DKA

and

Risk of lower limb amputation (including toes)

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

Recommend that the MA for ketoconazole to tx fungal infections should be suspended.

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

It’s an antihistamine - licensed for pruritis

Risk of QT-prolongation & tarsade de pointes

To minimise risk:
CI in QT prolongation or have risk factors for it
Consider risk when giving with drugs that power HR/CpK+
MAX adult dose: 100mg OD
MAX elderly dose: 50mg OD - ideally avoided

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

1.Adverse reactions in children who have had tonsillectomy due to obstructive sleep apnoea
•in children between 12-18 - max dose of 240mg/day limited to 3 days only
• CI in all children under 18 who undergo tonsillectomy/adenoidectomy due to obstructive sleep apnoea
•CI in ultra-rapid metaboliser CYP2D6
•not used in BF

2. Not to be sold OTC to children under 12 - risk of respiratory SE.