Drug/Drug classSafety AlertHealth/Regulatory AuthorityReference
Alemtuzumab
(genetic
recombination)		Risk of cervicocephalic
arterial dissection		Japan-PMDARevision of Precautions,
MHLW/PMDA, 21 January 2020
(www.pmda.go.jp/english/)
Atezolizumab
(genetic
recombination)		Risk of haemophagocytic
syndrome		Japan-PMDARevision of Precautions,
MHLW/PMDA, 3 December
2019 (www.pmda.go.jp/english/)
BilastineRisk of shock and
anaphylaxis		Japan-PMDARevision of Precautions,
MHLW/PMDA, 3 December
2019 (www.pmda.go.jp/english/)
Estradiol (creams)should only be used as
a single treatment for a
maximum of four weeks		Europe-EMAEMA, 17 January 2020
(www.ema.europa.eu)
Ingenol mebutateUse with caution in
patients with a history of
skin cancer		EMA & HPRADrug Safety Newsletter, HPRA,
December 2019 (www.hpra.ie) &  EMA, 17 January 2020
(www.ema.europa.eu)
IpragliflozinRisk of shock and
anaphylaxis		Japan-PMDARevision of Precautions,
MHLW/PMDA, 21 January 2020
(www.pmda.go.jp/english/)
LamotrigineRisk of adverse drug
reactions when switching
brands		Newzealand-MedsafeSafety Communication,
Medsafe, 20 December 2019
(www.medsafe.govt.nz/)
LevodopaRisk of dopamine
dysregulation syndrome		Newzealand-MedsafeRevision of Precautions,
MHLW/PMDA, 21 January 2020
(www.pmda.go.jp/english/)
LevothyroxinePotential adverse reactions
when switching brands		Ireland-HPRADrug Safety Newsletter, HPRA,
December 2019 (www.hpra.ie)
Mecasermin (genetic
recombination)		Potential risk of benign or
malignant tumours		Japan-PMDARevision of Precautions,
MHLW/PMDA, 3 December
2019 (www.pmda.go.jp/english/)
MethotrexateNew measures to avoid
dosing errors		Ireland-HPRADrug Safety Newsletter, HPRA,
December 2019 (www.hpra.ie)
ModafinilPotential risk of congenital
malformations		Newzealand-MedsafePrescriber Update, Medsafe,
December 2019
(www.medsafe.govt.nz/)
Olmesartan
medoxomil		Risk of interstitial
pneumonia		Japan-PMDARevision of Precautions,
MHLW/PMDA, 21 January 2020
(www.pmda.go.jp/english/)
Osimertinib mesilateRisk of congestive cardiac
failure and decreased left
ventricular ejection fraction		Japan-PMDARevision of Precautions,
MHLW/PMDA, 3 December
2019 (www.pmda.go.jp/english/)
Secukinumab
(genetic
recombination)		Risk of erythrodermaJapan-PMDARevision of Precautions,
MHLW/PMDA, 21 January 2020
(www.pmda.go.jp/english/)
Sodium-glucose cotransporter
2 (SGLT2)
inhibitors		Updated advice on
monitoring ketone bodies		Ireland-HPRADrug Safety Newsletter, HPRA,
December 2019 (www.hpra.ie)
TocilizumabRisk of hepatotoxicityAustralia-TGAMedicines Safety Update, TGA,
10 December 2019
?www.tga.gov.au??
Gabapentin,
Pregabalin		Risk of serious breathing
problems		US-FDASafety Alerts for Human
Medical Products, US FDA,
19 December 2019
(www.fda.gov)
IbuprofenRisk of renal toxicityNewzealand-MedsafePrescriber Update, Medsafe,
December 2019
(www.medsafe.govt.nz/)
LorcaserinPotential risk of cancerUS-FDASafety Alerts for Human
Medical Products, US FDA,
14 January 2020 (www.fda.gov)
Prednisolone (eye
drops)		Potential risk of systemic
effects		Newzealand-MedsafePrescriber Update, Medsafe, December 2019
(www.medsafe.govt.nz/)
Serotonin reuptake
inhibitors (SRIs)		Risk of suicide related
adverse events in children
and adolescents		Newzealand-MedsafePrescriber Update, Medsafe,
December 2019
(www.medsafe.govt.nz/)
TamoxifenDrug-drug interaction with
CYP2D6 inhibitors		Newzealand-MedsafePrescriber Update, Medsafe,
December 2019
(www.medsafe.govt.nz/)
TramadolRisk of opioid effects in
breastfeeding babies		Newzealand-MedsafeSafety Communication,
Medsafe, 8 January 2020
(www.medsafe.govt.nz/
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