July-Sep 2018
Inglese
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 depending on the type and dose of the drug administered.
Drug Indications
Enoxaparin is a low molecular weight heparin (LMWH) that is widely used in clinical practice. The treatment indications are:
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-valvular atrial fibrillation.
In un articolo apparso su Focus Farmacovigilanza nel 2014 sono stati discussi i principali effetti avversi dei farmaci antiepilettici.1 In tale articolo veniva sottolineato come l’assunzione di questi farmaci durante la gravidanza possa comportare un aumento del rischio di malformazioni fetali e come l’entità di questo rischio vari in rapporto al tipo e alla dose del farmaco somministrato.
Requiring a new warning about this risk to be added to the prescribing information of all SGLT2 inhibitors and to the patient Medication Guide.
FDA has reviewed the final results from the post-approval study conducted by SynCardia Systems, LLC. for their Temporary Total Artificial Heart (TAH-t) Companion 2 Driver System (C2 Driver System). These final results indicate a higher mortality rate and higher stroke rate for patients initially supported with the C2 Driver System compared to patients initially supported with the previous generation driver, the Circulatory Support System (CSS) Console.
The FDA is reminding health care providers that tests to detect rupture of the amniotic membranes should not be used without other clinical assessments to make critical patient management decisions.
L'Agenzia Italiana
del Farmaco (AIFA) rende disponibili nuove importanti informazioni di sicurezza riguardanti le nuove controindicazioni relative all’utilizzo dei farmaci contenenti retinoidi.
80.211.154.110