MHRA/CHM/CSM/CHMP/SAFETY⚠️ Flashcards
Important safety information about FLUCLOXACILLIN?
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
MHRA warning for BISPHOSPHONATES? (3)
- Atypical femoral FRACTURES
Report: thigh, hip, groin pain - OSTEONECROSIS OF JAW
IV bisphosphonates for Ca
Zolendronate = highest potency
Report: dental issues - BENIGN IDIOPATHIC OSTEONECROSIS OF EXTERNAL AUDITORY CANAL
Risk factors: >2y, steroids, infection, chemo, ear, cotton bud use
Report: ear pain, discharge or infection
MHRA warnings for WARFARIN?
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
Important safety information relating to quinolones
Quinolones = ciprofloxacin, levofloxacin, moxifloxacin, norfloxacin, ofloxacin
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!!!
MHRA/CHM advise on Quinine?
Dose-dependant QT-interval prolongation effects
Use in caution in patients with risk factors for QT-prolongation or those with AV-block
Warning related to the SGLT2 class?
What extra warning is there about canagloflozin?
Risk of Atypical DKA
Canagliflozin also has risk if atypical DKA
and
Risk of lower limb amputation (including toes)
What is the MHRA/CHM warning for corticosteroids?
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
What is the CHMP advice for KETOCONAZOLE?
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!
MHRA/CHM warning for hydroxyzine ??
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
MHRA reports on antipsychotics with dementia in elderly?
Increased risk of stroke
AND
Small increase risk of death
MHRAs advise on anti-epileptics
They are all associated with a small increased risk of suicidal thoughts and behaviours l
Safety information for itraconazole
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)
MHRA advise for thiamine VIT B1
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)
Codeine phosphate warnings ?
- 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 - Not sold OTC < 12 yo- risk of resp SE.
What does the black triangle mean?
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