Perspectives

The Safety of Medicines in the 21st Century – some thoughts

Sadly, although there are plans to continue the Erice meetings to consider other globally important aspects of pharmacology, therapeutics and drug safety, "A New Erice Report Considering the Safety of Medicines in the 21st Century"1was published just after the death...

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Focus on

The safety profile of direct oral anticoagulants
Direct oral anticoagulants (DOACs), also known as New Oral Anticoagulants (NAOs), have for the first time provided a therapeutic alternative to vitamin K antagonists (VKAs), of which warfarin is the prototype, indicating neither inferiority nor superiority in the prevention of stroke in case of non...
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Columns

Drugs & Pregnancy
Antiepileptic drugs in pregnancy: what are the risks for foetal development?
In an article that appeared in Focus Pharmacovigilance in 2014 the main adverse effects of antiepileptic drugs were discussed.1 In this article it was emphasised that the use of these drugs during pregnancy may lead to an increased risk of foetal malformations and how the extent of this risk varies...
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From regulatory agencies

23 January 2019 EMA
Comunicazione EMA su Lartruvo (olaratumab) (23/01/2019)
09 January 2019 CADTH
New at CADTH - January 2019
07 January 2019 AIFA
Nota Informativa Importante su Belkyra (acido desossicolico) (11/01/2019)
07 January 2019 AIFA
Nota Informativa Importante sul rischio di gangrena di Fournier associato all’uso di inibitori del SGLT2 (21/01/2019)
07 January 2019 AIFA
Nota Informativa Importante su medicinali a base di carbimazolo o tiamazolo (16/01/2019)
24 December 2018 AIFA
Nota Informativa Importante sui contraccettivi ormonali combinati (02/01/2019)
24 December 2018 AIFA
Nota Informativa Importante su JETREA (ocriplasmina) (28/12/2018)
20 December 2018 FDA
Fluoroquinolone Antibiotics: Safety Communication - Increased Risk of Ruptures or Tears in the Aorta Blood Vessel in Certain Patients
17 December 2018 AIFA
Nota Informativa Importante su Xyrem® (sodio oxibato) (21/12/2018)
14 December 2018 EMA
Comunicazione EMA su medicinali contenenti metamizolo (14/12/2018)
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