Focus on

Therapeutic error: patient’s safety at the core
Focus Farmacovigilanza 2014;81(3):2
The European Directive 2010/84/EU pledges pharmacovigilance on the front of the adverse events caused by therapeutic errors and inappropriate drug use: which opportunities arise and what critical points need to be solved yet?/p>Since July 2012, the new legislation allows a better management of...
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Statin treatment and onset of cough without pulmonary involvement
Focus Farmacovigilanza 2014;80(1):2
Three cases of cough in patients treated with atorvastatin Within the Viger project (Vigilance in geriatrics) three cases of cough induced by atorvastatin therapy have drawn our attention. In all cases the drug withdrawal determined symptomatology remission and in one case of rechallange the...
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Cardiovascular and metabolic risk associated to fluoroquinolones
Focus Farmacovigilanza 2013;79(11):2
Fluoroquinolones are wide-spectrum antibiotics largely used for treating infections – complicated and not – caused by susceptible bacteria. Even though they appear to be well tolerated, fluoroquinolones have been associated to several adverse reactions clinically relevant and potentially...
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Association between incretin mimetics and pancreas tumour: which evidence?
Focus Farmacovigilanza 2013;78(9):2
Incretin mimetics or GPL-1 mimetics (glucagon like peptide-1) are molecules used for the treatment of type 2 diabetes mellitus. These drugs stimulate the GLP-1 receptors by acting as exogenous agonist (i.e. exenatide and liraglutide) or like inhibitors of the dipeptidyl peptidase-4 (DPP4), the...
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Spontaneous reporting keeps growing in Italy
Focus Farmacovigilanza 2013;76(5):2
Spontaneous reporting data for Italy in 2012 will be shortly published by the AIFA1 portal. Numbers are once again surprising (Figure 1): more than 29,000 reports, with a 35% increase respect to 2011. The increase is higher for drugs (+41%) than for vaccines (+7%). The reporting rate (489 reports...
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Drug-induced gynecomastia
Focus Farmacovigilanza 2013;77(7):2
Gynecomastia characteristicsMale mammal glandular tissue, under particular conditions, can proliferate and increase in volume. This phenomenon - benign and generally reversible - is named gynecomastia (from greek gyné, woman, and mastós breast). Gynecomastia feels to touch like a rubbery mass...
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The effects of acetylcholinesterase inhibitors on the heart
Focus Farmacovigilanza 2013;75(3):3
Acetylcholinesterase inhibitors (AchEI), like donepezil, galantamine and rivastigmine are the only drugs – together with memantine (glutamate receptor antagonist) – which obtained the indication for the symptomatic treatment of Alzheimer disease, but are also used for the treatment of other types...
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Cardiovascular safety of NSAIDs: epidemiology and pharmacology
Focus Farmacovigilanza 2013;75(3):2
Eight years after the rofecoxib withdrawn, the EMA has published the conclusion of the third review on cardiovascular safety for traditional non-steroidal anti-inflammatory drugs.1“Traditional NSAIDs” refers to NSAIDs developed before it had been discovered that their efficacy was linked to the...
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Renal damage by dronedarone
Focus Farmacovigilanza 2013;74(1):3
Dronedarone is an antiarrhythmic drug approved by the EMA in 2009 for the treatment of some types of atrial fibrillation.[1] The EMA scientific report, to support the marketing authorization, states that the medicine is less effective but safer than amiodarone. Safety profile The pre-marketing...
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Drug-induced taste and smell disorders
Focus Farmacovigilanza 2013;74(1):2
Taste and smell alterations induced by medicines are quite common in the clinical practice with an estimated incidence ranging between 2 and 5%. Many drugs (or drugs classes) have been associated to these kind of adverse reactions, among them: ACE-inhibitors, betalattamic antibiotics, biguanides,...
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