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ArticleEuropean journal of clinical pharmacology2021

Unexpected beneficial effects of drugs: an analysis of cases in the Dutch spontaneous reporting system.

Florence van Hunsel, Corine Ekhart

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Article in European journal of clinical pharmacology, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

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Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

3 citing papers in PubMed.

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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

2 authors.

Florence van HunselNetherlands Pharmacovigilance Centre Lareb, Goudsbloemvallei 7, 5237 MH, 's-Hertogenbosch, The Netherlands. f.vanhunsel@lareb.nl.ORCID http://orcid.org/0000-0001-8965-3224
Corine EkhartNetherlands Pharmacovigilance Centre Lareb, Goudsbloemvallei 7, 5237 MH, 's-Hertogenbosch, The Netherlands.ORCID http://orcid.org/0000-0002-2252-0467

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionDrug use is inherently related to both beneficial effects on health as well as the occurrence of risks. The beneficial effects may be related to efficacy, the treatment range of a product, or even to user-friendliness of a product. However, in addition to the occurrence of adverse drug reactions, a drug can also have an unexpected beneficial effect on a patient's health, not related to the indication for which the drug was used. The aim of this article is to characterize the reports of unexpected beneficial effects of drugs in the Dutch spontaneous reporting system.

methodsA descriptive analysis was used to gain insight in number of reports and drug classes responsible for unexpected beneficial effects of drugs. Grouping of positive side effects into classes was done by a conventional qualitative content analysis of the cases.

resultsFour hundred nine reports which described unexpected beneficial effects of drugs were included, which mentioned 451 associations between suspected drugs and unexpected beneficial effects. There were 147 drug classes on the 4th ATC level involved. Content analysis of the reports gave rise to 22 categories of unexpected beneficial effects of drugs, including one "other category". DISCUSSION AND

conclusionThe analysis showed a diverse spectrum of reported reactions and drugs with some categories of unexpected beneficial effects of drugs mentioned multiple times for certain drug classes on the 4th ATC level. Most of these findings are consistent with the existing literature and knowledge on the pharmacological mechanism of the drugs in question. Coding harmonization would make it possible to study these effects in international databases.

Indexed as

HumansNetherlandsPharmacovigilanceProduct Surveillance, PostmarketingAntihistamineMigrainePharmacovigilanceUnexpected beneficial effectsUnexpected response

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.