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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Teaching pharmacovigilance: a comprehensive modular curriculum
Thanks to the global access to information on the Internet, patients have become more and more critic and sometimes worried about the potential adverse reactions to drugs. This situation has enhanced the necessity for their doctors and other health professionals to update their knowledge on...
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The abuse of "horse tranquilliser"
From Veterinary to humansKetamine, approved as dissociative general anaesthetic for human use by the Food and Drug Administration in the Seventies thanks to its good safety profile (retention of protective airway reflexes, hemodynamic stability and spontaneous ventilation) is a widely used...
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Levetiracetam and rhabdomyolysis
Despite rhabdomyolysis being mostly associated with statins, scientific evidences from literature also support the involvement of antiepileptic drugs, such as phenobarbital and phenytoin.1 Recently, a case of this syndrome was reported in a 27 years old patient under monotherapy of levetiracetam, a...
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Muscular adverse drug reactions associated with proton pump inhibitors: an analysis of Italian data
Statins are considered the first potential pharmacological cause of muscular damage. Even though this was a well-known muscular adverse reaction, when fatal cases of rhabdomyolysis – the most severe muscular adverse reaction – triggered the withdrawal of cerivastatin from the market in 2001, a...
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Cutaneous adverse reactions to antiepileptic drugs
Focus Farmacovigilanza 2017;97(6):1
The skin is frequently affected by adverse drug reactions and basically any class of drugs – but NSAIDs, antibiotics and antiepileptic drugs (AEDs) with particular frequency – can cause them (see table).1Children with an adverse drug reaction present a cutaneous manifestation in 16% to 35% of cases...
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Prescription inappropriateness in geriatrics: the STOPP&START criteria today
Focus Farmacovigilanza 2017;96(3):1
The management of the pharmacological therapy in the elderly patient has become more and more a relevant and critical aspect.1 The physiological aging process is characterised by structural and functional changes that affect all systems and translate in a reduced ability to maintain homeostasis and...
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Acetaminophen during pregnancy: possible consequences for the child?
Focus Farmacovigilanza 2016;95(11):5
Acetaminophen is generally considered safe during pregnancy. However, recent studies seem to link its use with some risks for the unborn. The signal has been highlighted by researchers of the University of Bristol and Cardiff, whom analyzed the long-term results of a cohort enrolled at birth (7,796...
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Light and shadows of natural products
Focus Farmacovigilanza 2016;94(9):1
These products are generally considered completely harmless, but their active ingredients exert a biological function in the organism and can, therefore, have side effects or interact with drugs. Non-conventional medicines in Italy Non-conventional therapies are therapeutic practices,...
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Biosimilar epoetins under safety scrutiny
Focus Farmacovigilanza 2016;93(3):7
Chronic renal failure represents nowadays one of the biggest public health issues worldwide: it is estimated that in Italy one person over seven people has a moderate impairment of the renal function, i.e. a halved renal functionality, or more than halved, in comparison with the norm.1 Chronic...
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