MHRA drug safety update 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 warnings for BISPHOSPHONATES?
- ATYPICAL FEMORAL FRACTURES Report: thigh, hip, groin pain
- OSTEONECROSIS OF JAW
Zolendronate = highest risk = highest potency Report: dental issues - BENIGN IDIOPATHIC OSTEONECROSIS OF EXTERNAL AUDITORY CANAL Risk factors: >2y use, steroids, infection, chemo, ear op, cotton bud use
- Report: ear pain, discharge or infection
MHRA/CHM warnings for WARFARIN?
~ Reports of Calciphylaxis: rare painful syndrome of calcification of small Blood Vessels in fatty tissue & deeper layers of skin = blood clots/death
~ be alert to risk of drug interactions with tramadol (June 2024)
= bleed on the brain after taking warfarin with tramadol.
= risk of increased INR when warfarin + tramadol taken together = potentially life-threatening bruising and bleeding;
2 Important safety information relating to quinolones.
May induce CONVULSIONS in pts with/without history of convulsions. Taking NSAID’s at 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 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!!!
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 SGLT-2 inhibitors?
Risk of Atypical DKA
Risk of lower limb amputation (including toes)
Fournier’s gangrene (necrotising fasciitis of genitalia or perineum)
NOT given in T1DM !
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 + referral to ophthalmologist for evaluation
What is the CHMP advice for KETOCONAZOLE?
Risk of hepatotoxicity associated with ORAL 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
ORAL ketoconazole for Cushing syndrome and topical products don’t apply to this!
MHRA/CHM warning for hydroxyzine?
Risk of QT-prolongation & torsade de pointes
Contra. in QT prolongation or in those with risk factors for it.
MHRA reports on antipsychotics with dementia in elderly?
Increased risk of stroke and Small increase risk of death
MHRAs advice on anti-epileptics?
All associated with small increased risk of suicidal thoughts & behaviours
Safety information for itraconazole
REPORTS OF HEART FAILURE
~ Caution prescribing if high risk of HF.
~ Those at risk: receiving high doses/longer courses
older patients/cardiac disease,
chronic lung disease (COPD) associated with pulmonary HTN
receiving treatment with NEGATIVE INOTROPIC DRUGS - CCB
~ AVOID if ventricular dysfunction/history of HF (unless infection serious)
MHRA advise for thiamine VIT B1.
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)
Codeine phosphate warnings?
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
