Drug/Drug class | Safety Alert | Health/Regulatory Authority | Reference |
Alemtuzumab (genetic recombination) | Risk of cervicocephalic arterial dissection | Japan-PMDA | Revision of Precautions, MHLW/PMDA, 21 January 2020 (www.pmda.go.jp/english/) |
Atezolizumab (genetic recombination) | Risk of haemophagocytic syndrome | Japan-PMDA | Revision of Precautions, MHLW/PMDA, 3 December 2019 (www.pmda.go.jp/english/) |
Bilastine | Risk of shock and anaphylaxis | Japan-PMDA | Revision 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-EMA | EMA, 17 January 2020 (www.ema.europa.eu) |
Ingenol mebutate | Use with caution in patients with a history of skin cancer | EMA & HPRA | Drug Safety Newsletter, HPRA, December 2019 (www.hpra.ie) & EMA, 17 January 2020 (www.ema.europa.eu) |
Ipragliflozin | Risk of shock and anaphylaxis | Japan-PMDA | Revision of Precautions, MHLW/PMDA, 21 January 2020 (www.pmda.go.jp/english/) |
Lamotrigine | Risk of adverse drug reactions when switching brands | Newzealand-Medsafe | Safety Communication, Medsafe, 20 December 2019 (www.medsafe.govt.nz/) |
Levodopa | Risk of dopamine dysregulation syndrome | Newzealand-Medsafe | Revision of Precautions, MHLW/PMDA, 21 January 2020 (www.pmda.go.jp/english/) |
Levothyroxine | Potential adverse reactions when switching brands | Ireland-HPRA | Drug Safety Newsletter, HPRA, December 2019 (www.hpra.ie) |
Mecasermin (genetic recombination) | Potential risk of benign or malignant tumours | Japan-PMDA | Revision of Precautions, MHLW/PMDA, 3 December 2019 (www.pmda.go.jp/english/) |
Methotrexate | New measures to avoid dosing errors | Ireland-HPRA | Drug Safety Newsletter, HPRA, December 2019 (www.hpra.ie) |
Modafinil | Potential risk of congenital malformations | Newzealand-Medsafe | Prescriber Update, Medsafe, December 2019 (www.medsafe.govt.nz/) |
Olmesartan medoxomil | Risk of interstitial pneumonia | Japan-PMDA | Revision of Precautions, MHLW/PMDA, 21 January 2020 (www.pmda.go.jp/english/) |
Osimertinib mesilate | Risk of congestive cardiac failure and decreased left ventricular ejection fraction | Japan-PMDA | Revision of Precautions, MHLW/PMDA, 3 December 2019 (www.pmda.go.jp/english/) |
Secukinumab (genetic recombination) | Risk of erythroderma | Japan-PMDA | Revision 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-HPRA | Drug Safety Newsletter, HPRA, December 2019 (www.hpra.ie) |
Tocilizumab | Risk of hepatotoxicity | Australia-TGA | Medicines Safety Update, TGA, 10 December 2019 ?www.tga.gov.au?? |
Gabapentin, Pregabalin | Risk of serious breathing problems | US-FDA | Safety Alerts for Human Medical Products, US FDA, 19 December 2019 (www.fda.gov) |
Ibuprofen | Risk of renal toxicity | Newzealand-Medsafe | Prescriber Update, Medsafe, December 2019 (www.medsafe.govt.nz/) |
Lorcaserin | Potential risk of cancer | US-FDA | Safety Alerts for Human Medical Products, US FDA, 14 January 2020 (www.fda.gov) |
Prednisolone (eye drops) | Potential risk of systemic effects | Newzealand-Medsafe | Prescriber Update, Medsafe, December 2019 (www.medsafe.govt.nz/) |
Serotonin reuptake inhibitors (SRIs) | Risk of suicide related adverse events in children and adolescents | Newzealand-Medsafe | Prescriber Update, Medsafe, December 2019 (www.medsafe.govt.nz/) |
Tamoxifen | Drug-drug interaction with CYP2D6 inhibitors | Newzealand-Medsafe | Prescriber Update, Medsafe, December 2019 (www.medsafe.govt.nz/) |
Tramadol | Risk of opioid effects in breastfeeding babies | Newzealand-Medsafe | Safety Communication, Medsafe, 8 January 2020 (www.medsafe.govt.nz/ |