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 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 blood vessels 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

CONVULSIONS in pts with/without history
Taking NSAID’s at the same time may also induce them
TENDON DAMAGE - May occur within 48hours of starting tx - cases reported several months after stopping tx.
HCP are reminded:
CI - pts history of tendon disorders
Risk of tendon damage ^ by 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 SGLT2 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

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 ^ risk of HF. Those at risk include:
•receiving high doses/longer courses
•older pts/those with cardiac disease
•COPD assoc. with pulmonary HTN
•receiving tx 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 ADR - rare - 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. ADR children who have had tonsillectomy due to obstructive sleep apnoea
   •in children 12-18 yrs max dose of 240mg/day limited to 3 days only
   • CI in all <18 who undergo tonsillectomy/adenoidectomy due to obstructive sleep apnoea
   •CI in ultra-rapid metaboliser CYP2D6
   •not used in breastfeeding
2. Not sold OTC < 12 yo- risk of resp SE.

Question 15

What does the black triangle mean?

Answer 15

Means this drug is recently on the market- so it prompts people that all ADR’s need to be reported with these drugs.

Usually kept for 5 years

Question 16

By law, manufacturers must report to the MHRA any important defects in both medicines and medical devices. What can Warnings/ Alerts be issued about?

Answer 16

Defective medicines

Problems with devices

SE associated with medicines and blood products.

Question 17

Class 4 MHRA defective medicines alert: requires action within?

Answer 17

Means caution in use only no threat to pt indicates that the product poses no threat to patient safety usually relates to minor defects in packaging material

Question 18

Class 3 MHRA defective medicines alert: requires action within?

Answer 18

5 days

the defect is unlikely to harm patients and is being carried out for reasons other than patient safety. Eg noncompliance with MA

Question 19

Class 2 MHRA defective medicines alert: requires action within?

Answer 19

48 hours

the defect could harm the patient but is not life threatening

Question 20

Class 1 MHRA defective medicines alert: requires action within?

Answer 20

24 hours

Immediate recall: because the product poses a serious or life threatening risk to health

Question 21

Side effects: Very rare definition?

Answer 21

Less than 1 in 10,000 experience this

Question 22

Side effects: Rare definition?

Answer 22

1 in 10,000 to 1 in 1000

Question 23

Side effects: Uncommon definition?

Answer 23

1 in 1000 to 1 in 100

Question 24

Side effects: common definition?

Answer 24

1 in 100 to 1 in 10

Question 25

Side effects: VERY Common definition?

Answer 25

1 in 10