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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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

14 December 2018 EMA
Comunicazione EMA su medicinali contenenti metamizolo (14/12/2018)
14 December 2018 EMA
Comunicazione EMA su medicinali contenenti fosfomicina (14/12/2018)
14 December 2018 EMA
Comunicazione EMA su acidi grassi omega-3 (14/12/2018)
26 November 2018 AIFA
Nota Informativa Importante sui medicinali a base di cefepime (26/11/2018)
20 November 2018 FDA
Gilenya (fingolimod): Drug Safety Communication - Severe Worsening of Multiple Sclerosis After Stopping the Medicine
19 November 2018 EMA
Comunicazione EMA sul principio attivo Valsartan (19/11/2018)
16 November 2018 EMA
Comunicazione EMA su Antibiotici Fluorochinolonici e chinolonici (16/11/2018)
14 November 2018 FDA
Implanted Pumps: Safety Communication - Use Caution When Selecting Pain Medicine for Intrathecal Administration
12 November 2018 CADTH
New at CADTH - November 2018
15 October 2018 EMA
Comunicazione EMA sulla revisione dei sartani (15/10/2018)
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