Focus on

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Eight years after the rofecoxib withdrawn, the EMA has published the conclusion of the third review on cardiovascular safety for traditional non-steroidal anti-inflammatory drugs.1“Traditional NSAIDs”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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Botulinum toxin adverse effects
Focus Farmacovigilanza 2012;73(11):2
Clostridium botulinum, anaerobic gram positive bacteria, produces seven different types of toxins, named with alphabet letters from A to G. In clinical practice (Table 1) only toxin A (Botox®, Vistabex®, Dysport®) and B (Neurobloc®) are used. These drugs contain a complex of real toxin and a non-...
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