ebba holme hansen

Through manual review of clinical notes for patients with type 2 diabetes mellitus attending a Danish diabetes center, the aim of the study was to identify adverse drug reactions(ADRs) associated with three classes of glucose‑lowering medicines: “Combinations of oral blood‑glucose lowering medicines” (A10BD), “dipeptidyl peptidase‑4 (DDP‑4) inhibitors” (A10BH), and “other blood glucose lowering medicines” (A10BX). Specifically, we aimed to describe the potential of clinical notes to identify new ADRs and to evaluate if sufficient information can be obtained for causality assessment.

For observed adverse events (AEs) we extracted time to onset, outcome, and suspected medicine(s). AEs were assessed according to World Health Organization-Uppsala Monitoring Centre causality criteria and analyzed with respect to suspected medicines, type of ADR (system organ class), seriousness and labeling status.

A total of 207 patients were included in the study leading to the identification of 163 AEs. 14% were categorized as certain, 60% as probable/likely, and 26% as possible. 15 (9%) ADRs were unlabeled of which two were serious: peripheral edema associated with sitagliptin and stomach ulcer associated with liraglutide. Of the unlabeled ADRs, 13 (87%) were associated with “other blood glucose lowering medications,” the remaining 2 (13%) with “DDP‑4 inhibitors.”

Clinical notes could potentially reveal unlabeled ADRs associated with prescribed medicines and sufficient information is generally available for causality assessment. However, manual review of clinical notes is too time-consuming for routine use and hence there is a need for developing information technology (IT) tools for automatic screening of patient records with the purpose to detect information about potentially serious and unlabeled ADRs.

To characterise consumer adverse drug reaction (ADR) reports for phosphodiesterase type 5 (PDE5) inhibitors.

We included ADR reports submitted by adults to the European ADR database (EudraVigialnce) from 2007 to 2011. ADRs were classified according to type, seriousness and age and sex of consumers. The unit of analysis was one ADR.

Totally,328ADRs were reported for sildenafil and vardenafil,and only 5% of these were serious.The largest number of reported ADRs was found for sildenafil, i.e., “lack of efficacy” and/or “drug efficacy decreased” (n = 134) and “headache” (n = 21).

ADRs reported by consumers for PDE5 inhibitors were relatively low, and only few ADRs were serious.

To characterize adverse drug reactions (ADRs) reported by European (EU) consumer for antineoplastic and immunomodulating medications.

ADRs reported by consumers of antineoplastic and immunomodulating medications (anatomical therapeutic chemical [ATC]) group L from 2007 to 2011 and located in the EU ADR database, EudraVigilance, were analyzed. Data were categorized with respect to age and sex, category, and seriousness of reported ADRs and medications. The unit of analysis was one ADR.

We located 9649 ADRs reported for antineoplastic and immunomodulating medications, which approximately 15% of were serious, including 26 deaths. Less than 5% of ADRs were reported in children. Totally 73% of ADRs were reported for women and 27% for men. The majority of ADRs were of the type “general disorders and administration site conditions” (54% of total ADRs), followed by “skin and subcutaneous disorders” (7% of total ADRs), and “infections and infestations” (6% of total ADRs). Reports encompassed medicines from the therapeutic groups: Imunosupressants (ATC group L04) (90% of all ADRs), immunostimulants (ATC group L03) (6% of all ADRS), and antineoplastic agents (ATC group L01) (4% of all ADRs). Many ADRs were reported for etanercept (Enbrel®), Interferon beta (Betaferon®/Extavia®), and imatinib (Glivec®) with only few being serious.

In general, consumers reported a high number of ADRs from the use of antineoplastic and immunostimulant medications and many of these were classified as non‑serious. This indicates that consumers are interesting in reporting ADRs, but since the investigated substances potentially have the risk of causing many ADRs, we expected a higher number of serious ADRs.