The economic burden of preventable adverse drug reactions: a systematic review of observational studies.

INTRODUCTION: Adverse drug reactions (ADRs) are an important cause of morbidity and mortality worldwide. They are associated with healthcare costs due to hospital admissions or prolonged length of stay, as well as additional interventions. The aim of this study was to conduct a systematic review of observational studies to evaluate the economic impact of preventable ADRs. AREAS COVERED: Published observational research investigating the cost of preventable ADRs in Western countries (limited to the USA and European countries). EXPERT OPINION: Several reviews have been carried out in the field of the ADR epidemiology but fewer reviews have investigated the economic impact of ADRs, and at the time of writing, none has focused on preventable ADRs. The reason why future research should focus on the costs of preventable ADRs is that both the costs and the negative clinical outcomes are preventable, and as such, are a key point of public health policy action. Nevertheless, the present review highlights an important and sobering limitation of published research on the cost of preventable ADRs, of which the major limitation is the heterogeneity in methods and in reporting which limit what can be known through the summarizing work of a systematic review.

Lateralized exanthem mimicking figurate inflammatory dermatosis of infancy after methimazole therapy.

We reported a case of an 11-year-old girl admitted to our hospital for goiter, tachycardia, sweating, and visible and palpable thyroid. Thyroid function tests revealed a low thyrotropin level (<0.004 mIU/L) and elevated free thyroxine level (3.4 ng/ dL) diagnosed with Graves' disease and treated with methimazole. This anti-thyroid drug is recommended as first-line treatment in children with Graves' disease because it produces minor adverse effects with respect to propylthiouracil. She developed a lateralized exanthem mimicking figurate inflammatory dermatosis of infancy after methimazole therapy. The symptoms resolved after discontinuation of methimazole and treatment with an antihistamine and a corticosteroid. Furthermore, the treatment was changed to propylthiouracil without any adverse effects. According to current literature this is the first case of cutaneous figurate erythema related to methimazole, different from other well-known reactions such as skin eruption or urticaria.

Incretin-based therapy and acute cholecystitis: a review of case reports and EudraVigilance spontaneous adverse drug reaction reporting database.

WHAT IS KNOWN AND OBJECTIVE: Glucagon-like peptide-1 (GLP-1) receptor agonists delay gastric and bowel emptying. A similar inhibitory effect of GLP-1 on gallbladder motility has been suggested, possibly leading to an increased risk of cholecystitis related to incretin-based medications, which include GLP-1 antagonists. Our objective was to review evidence in EudraVigilance, the European spontaneous reporting database and the scientific literature on this issue. COMMENT: Increasing evidence suggests an association of incretins with gallbladder adverse events. Pharmacovigilance data from EudraVigilance includes 200 serious ADR reports concerning cholecystitis related to the use of incretin-based therapies. Several mechanisms may explain this increased risk of cholecystitis, including rapid weight loss, inhibition of gallbladder contraction and emptying, reduced bile acids production, modulation of inflammation. WHAT IS NEW AND CONCLUSIONS: The available data suggest the possibility of gallbladder disease in diabetic subjects treated with incretins and highlight the importance of evaluating risk factors for cholelithiasis and gallbladder diseases in patients with diabetes before starting this therapy.

[Adverse drug reactions in childhood. A drug surveillance study in Sicily]. / Reazioni avverse da farmaci in età pediatrica. Studio di farmacovigilanza in Sicilia.

The aim of the present study was to investigate the spontaneous reports of suspected adverse drug reactions, observed in paediatric patients in Sicily during the period between the 1st January 1995 and the 31st August 1997. The ADRs were classified according to the "WHO Programme for International Monitoring of Adverse Reactions to Drugs". On 1020 reports, the paediatric suspected ADRs were 130 (12.7%); 23% of these was serious, and 29.2% involved children aged 3 years or less. The antimicrobial and the musculoskeletal drugs were responsible of 74.6% of the whole suspected paediatric ADRs. Cutaneous and gastrointestinal apparatus were involved in 70% of reports and were the most frequently targets of ADRs. On 57 different molecules ceftriaxone and co-amoxiclav were the most common drugs causing ADRs with a percentage of 13%. In 45.4% of ADRs the suspension of the treatment occurred, in 34.6% therapy was needed besides the suspension of the drug, whilst in 11.5% patients needed an hospital visit. In 59.2% spontaneous reports were sent by hospitals, in 32.3% by primary health care and the remaining percentage by other sources. Our investigation should stimulate physicians to better evaluate the potential side effects of drugs and the cost/effectiveness profile of paediatric therapies.