Pharmacovigilance in Italy: An overview

Mazzitello, Carmela; Esposito, Stefania; Francesco, Adele Emanuela De; Capuano, Annalisa; Russo, Emilio; Sarro, Giovambattista De

doi:10.4103/0976-500x.120942

Cited by 67 publications

(50 citation statements)

References 28 publications

(50 reference statements)

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“…This study has several limitations. First, we relied on spontaneous reporting, which is subject to under-reporting and lack of information [ 36 , 37 ]. All data were retrospective and we were unable to confirm accuracy or replace missing data.…”

Section: Discussionmentioning

confidence: 99%

Patterns of Adverse Drug Reactions in Different Age Groups: Analysis of Spontaneous Reports by Community Pharmacists

Shin

Lee

et al. 2015

PLoS ONE

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PurposeTo evaluate the clinical manifestations and causative drugs associated with adverse drug reactions (ADRs) spontaneously reported by community pharmacists and to compare the ADRs by age.MethodsADRs reported to the Regional Pharmacovigilance Center of the Korean Pharmaceutical Association by community pharmacists from January 2013 to June 2014 were included. Causality was assessed using the WHO-Uppsala Monitoring Centre system. The patient population was classified into three age groups. We analyzed 31,398 (74.9%) ADRs from 9,705 patients, identified as having a causal relationship, from a total pool of 41,930 ADRs from 9,873 patients. Median patient age was 58.0 years; 66.9% were female.ResultsGastrointestinal system (34.4%), nervous system (14.4%), and psychiatric (12.1%) disorders were the most frequent symptoms. Prevalent causative drugs were those for acid-related disorders (11.4%), anti-inflammatory products (10.5%), analgesics (7.2%), and antibacterials (7.1%). Comparisons by age revealed diarrhea and antibacterials to be most commonly associated with ADRs in children (p < 0.001), whereas dizziness was prevalent in the elderly (p < 0.001). Anaphylactic reaction was the most frequent serious event (19.7%), mainly associated with cephalosporins and non-steroidal anti-inflammatory drugs. Among 612 ADRs caused by nonprescription drugs, the leading symptoms and causative drugs were skin disorders (29.6%) and non-steroidal anti-inflammatory drugs (16.2%), respectively.ConclusionsAccording to the community pharmacist reports, the leading clinical manifestations and causative drugs associated with ADRs in outpatients differed among age groups.

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Section: Discussionmentioning

confidence: 99%

Patterns of Adverse Drug Reactions in Different Age Groups: Analysis of Spontaneous Reports by Community Pharmacists

Shin

Lee

et al. 2015

PLoS ONE

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“…Firstly, severe hyponatremia may occur despite rather than due to any glucose-lowering medication or underlying diabetic disease. Secondly, the current study exemplifies the importance of postmarketing surveillance to reveal hitherto unrecognized properties of medications and to evaluate the real-world effectiveness and safety of the drug [39,40].…”

Section: Resultsmentioning

confidence: 89%

Inverse association between glucose-lowering medications and severe hyponatremia: a Swedish population-based case-control study

et al. 2019

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Context Glucose-lowering medications have occasionally been reported to cause hyponatremia, but the evidence is scarce. Objectives To explore the association between glucose-lowering medications and severe hyponatremia. Design, setting, and participants Subjects hospitalized with a principal diagnosis of hyponatremia (n = 14,359) were compared with matched controls (n = 57,383). Data were derived by linkage of national population-based registers. Multivariable logistic regression adjusting for co-medication, diseases, previous hospitalizations, and socioeconomic factors was used to explore the association between hospitalization for hyponatremia and the use of different glucose-lowering medications. Furthermore, newly initiated (≤90 days) and ongoing use was investigated separately. Main outcome measures Hospitalization due to hyponatremia. Results The unadjusted ORs (95% CI) for hospitalization due to hyponatremia were 1.41 (1.29-1.54) for insulins, 1.38 (1.27-1.50) for metformin, and 1.22 (1.07-1.38) for sulfonylureas. However, after adjustment for confounding factors the association was consistently reversed. Thus, for any glucose-lowering medication the adjusted OR was 0.63 (0.58-0.68). For insulins, metformin and sulfonylureas, adjusted ORs (95% CI) were 0.58 (0.52-0.65), 0.81 (0.72-0.90) and 0.81 (0.69-0.94), respectively. Odds ratios for newly initated medications were overall higher while those for ongoing treatment were further decreased. Thus, adjusted ORs (95% CI) for ongoing treatment with insulins, metformin, and sulfonylureas were 0.54 (0.48-0.61), 0.82 (0.73-0.91) and 0.78 (0.66-0.92). Conclusions Glucose-lowering medications did not increase the risk for hospitalization due to severe hyponatremia. In fact, the association was inverse across all investigated drugs. The association may be mediated by pharmacologic mechanisms, but the uniform effects across drug-classes suggest properties of the diabetic disease are of importance.

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“…Therefore, there is a need for studies designed to assess the tolerability profile of this class of drugs when used in pregnancy in order to minimize risks both for the unborn that for pregnant women. For this reason pharmacovigilance post-marketing studies are key elements to monitor the safety and effectiveness of approved drugs,[ 33 34 35 36 37 ] especially when used in special conditions such as pregnancy.…”

Section: Discussionmentioning

confidence: 99%

Hypoglycemia, polycythemia and hyponatremia in a newborn exposed to nebivolol during pregnancy

Sullo

Perri

Sibilio

et al. 2015

Journal of Pharmacology and Pharmacotherapeutics

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Nebivolol is a third-generation beta blocker that exerts selective antagonistic activity on β1 receptors. It has vasodilating properties that result from direct stimulation of endothelial nitric oxide synthase. Nebivolol is indicated for the treatment of hypertension and heart failure, and is generally well tolerated. In this article, we report a case of an infant who was admitted to the Pediatrics and Neonatology Unit of the Moscati Hospital (Aversa, Italy) about 24 hours after birth. The reason for hospitalization was persistent severe hypoglycemia (blood glucose = 30 mg/dL) and jaundice (total bilirubin = 12.5 mg/dL, indirect bilirubin 11.75 mg/dL). He was born by spontaneous delivery after a normal term pregnancy. Birth weight was 3040 g and the Apgar score was 6-9. The mother reported taking nebivolol 5 mg/day for unspecified tachycardia in the last 4 months of pregnancy. Clinical and instrumental investigations carried out during hospitalization did not reveal any congenital or perinatal abnormalities. After treatment for metabolic and electrolyte imbalance, he was discharged on the 10th day of hospitalization, in good clinical condition and with normalization of clinical and laboratory parameters. Currently, there are no specific studies on nebivolol tolerability during pregnancy. Our data suggest that the risk profile of nebivolol during pregnancy is the same as that of other β-blockers. Therefore, further studies are required to determine the safety of β-blockers during pregnancy and the risks to the unborn child.

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Pharmacovigilance in Italy: An overview

Cited by 67 publications

References 28 publications

Patterns of Adverse Drug Reactions in Different Age Groups: Analysis of Spontaneous Reports by Community Pharmacists

Patterns of Adverse Drug Reactions in Different Age Groups: Analysis of Spontaneous Reports by Community Pharmacists

Inverse association between glucose-lowering medications and severe hyponatremia: a Swedish population-based case-control study

Hypoglycemia, polycythemia and hyponatremia in a newborn exposed to nebivolol during pregnancy

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