Safety profile of the direct oral anticoagulants: an analysis of the WHO database of adverse drug reactions

Monaco, Luca; Biagi, Carlotta; Conti, Valentino; Melis, Mauro; Donati, Monia; Venegoni, Mauro; Vaccheri, Alberto; Motola, Domenico

doi:10.1111/bcp.13234

Cited by 35 publications

(44 citation statements)

References 41 publications

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“…NOACs offer convenient treatment with faster on‐ and offset, fixed dosage schemes, no regular laboratory controls and few drug and food interactions . In Germany, use of these agents has increased substantially in recent years .…”

Section: Introductionmentioning

confidence: 99%

“…In Germany, use of these agents has increased substantially in recent years . However, there are concerns about the assessment of the anticoagulant status in critical situations and the overall medication adherence without coagulation monitoring, the lack of specific antidotes for most of these agents, the dosing in special groups of patients and the higher drug costs compared with VKA .…”

Section: Introductionmentioning

confidence: 99%

See 1 more Smart Citation

Use of oral anticoagulants in German nursing home residents: drug use patterns and predictors for treatment choice

Jobski

Hoffmann

Herget–Rosenthal

et al. 2018

Brit J Clinical Pharma

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Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Use of oral anticoagulants in German nursing home residents: drug use patterns and predictors for treatment choice

Jobski

Hoffmann

Herget–Rosenthal

et al. 2018

Brit J Clinical Pharma

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show abstract

“…Furthermore, the occurrence of off‐target ADRs are not predictable based on the drug's specific therapeutic effect 1 . Therefore, postmarketing surveillance (PMR) schemes have been introduced in many countries and internationally to improve patient safety by identifying previously unrecognized ADRs, drug interactions, and patient subgroup vulnerability 3‐5 . However, these schemes are reactive rather than proactive.…”

Section: Introductionmentioning

confidence: 99%

Relevance of physicochemical properties and functional pharmacology data to predict the clinical safety profile of direct oral anticoagulants

Ferro

Solkhon

Jalal

et al. 2020

Pharmacology Res & Perspec

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Direct oral anticoagulants (DOACs) have rapidly become the drug class of choice for anticoagulation therapy in secondary care. It is known that gastrointestinal hemorrhage are potential side effects of the DOAC drug class. In this study we have investigated the relevance of molecular structure and on/off‐target pharmacology as a predictor of adverse drug reactions (ADRs) for the DOAC drug class. Use of the Reaxys MedChem module allowed for data mining of all possible reported off‐target effects of the DOAC class members. For the first time, the MHRA Yellow card database in combination with prescribing rates in the United Kingdom (data for n = 30 566 936 DOAC Rx (up to 2017) and ADR data n = 22 275 (up to 2018)) were used for our data comparison of DOACs. From the underlying reported data, we were able to rank the DOACs in terms of the likely adverse events we would expect to observe. We identified potential risks of ADRs based on the DOACs pharmacology including the expected GI hemorrhage, but also the unexpected risk of stroke, pulmonary embolism and kidney injury. Statistically significant (P < .001) differences were found between all DOACs and their total number of ADRs. Although the risks are small, strong statistical correlation between observed pharmacology and national ADR data is observed in three out of the five areas of concern.

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“…4) Each of these data sources has its own role in evaluating post-marketing drug safety. When evaluating the safety of post-marketing drugs, some studies [5][6][7] used the ADRs from spontaneous reporting databases such as VigiBase (the WHO database of ADRs) or other spontaneous reporting databases as the data source for their research. However, the ADRs from RCTs and case reports were not within the scope of these studies.…”

Section: Introductionmentioning

confidence: 99%

Comparison of Three Different Data Sources of Adverse Drug Reactions Using Adverse Drug Reaction Data of Fluorouracil for Gastric Cancer as an Example

Niu

Chen

Xiang

et al. 2020

Biological & Pharmaceutical Bulletin

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Various sources of information are available for identifying and evaluating adverse drug reactions (ADRs). However, some studies only used the ADR data from spontaneous reporting databases to evaluate the safety of post-marketing drugs. This study was performed to identify an appropriate method for evaluating the safety of post-marketing drugs by comparing the frequencies of ADRs among three datasets: randomized controlled trials, published case reports, and spontaneous reports. Taking ADR data for fluorouracil as an example, we collected the three types of data and extracted their ADR information. All listed ADRs were sorted by frequency from high to low, and the top five ADRs were chosen from each dataset. We assigned an index value of 1.0 to the frequency of one specific ADR (diarrhea) and then calculated the index values of the other ADRs relative to diarrhea. Ten different ADRs were mentioned in the top five ADRs of the three datasets, and only diarrhea and nausea/vomiting were included in all three datasets. The rank orders of the top five ADRs varied among the three datasets. Nausea and vomiting was the most frequent ADR in all three datasets; the remaining ADRs differed among the datasets. There were significant differences in the recording of ADRs and the frequency distributions among the three datasets. A comprehensive and reliable safety profile for post-marketing drugs should not be based on any one source. Spontaneous reports from monitoring institutions provided the most ADR data. Randomized controlled trials and case reports published in the literature can supplement the results from spontaneous reports.

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Safety profile of the direct oral anticoagulants: an analysis of the WHO database of adverse drug reactions

Cited by 35 publications

References 41 publications

Use of oral anticoagulants in German nursing home residents: drug use patterns and predictors for treatment choice

Use of oral anticoagulants in German nursing home residents: drug use patterns and predictors for treatment choice

Relevance of physicochemical properties and functional pharmacology data to predict the clinical safety profile of direct oral anticoagulants

Comparison of Three Different Data Sources of Adverse Drug Reactions Using Adverse Drug Reaction Data of Fluorouracil for Gastric Cancer as an Example

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