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Characteristics of adverse drug reactions due to nonsteroidal anti-inflammatory drugs: a cross-sectional study

Sonsupap, Cholticha Pokhakul, Pattreya Kariya, Tetsuyoshi Suzuki, Yunosuke Hamajima, Nobuyuki Yamamoto, Eiko 名古屋大学

2023.11

概要

Non-steroidal anti-inflammatory drugs (NSAIDs) are the most commonly prescribed medications for treating pain and inflammation. 1-5 NSAIDs reduce the production of biochemicals
involved in inflammation, pain, and fever through inhibiting cyclooxygenases (COXs). The two
COX isoforms (COX-1 and COX-2) are the main targets of NSAIDs.6,7 COX-1 is expressed in
most tissues, including the gastrointestinal mucosa, platelets, endothelium, kidneys, and uterus,
and functions as a housekeeping enzyme that maintains homeostasis.8,9 On the other hand,
COX-2 is induced during inflammation.10 The gastrointestinal side effects of inhibiting COX-1
are well-known adverse drug reactions (ADRs) associated with the use of NSAIDs.1,11 A previous
study has shown that the most frequently reported serious ADRs due to NSAIDs are cutaneous
diseases followed by gastrointestinal, hepatic, renal, and cardiovascular events.12 Several studies
also demonstrated the risks of ADRs accompanied with some NSAIDs; valdecoxib increased the
risk of thrombotic adverse events,13 and rofecoxib exerted a risk of a heart attack.14 As a result,
these drugs were removed from the global market.
Reporting the ADRs of post-marketing products is an important surveillance system for drug
safety. The spontaneous reporting system is widely used worldwide,15,16 although it may exhibit
some limitations, such as incomplete information and under-reporting.15,17 By using cumulative
and a large number of reports from multiple sources, unknown ADRs may be identified. An
in-depth analysis of such big data may be helpful to ensure the safety of drug use by the public,
to determine which drug needs regulation and management, and to set individual drug priorities
in drug safety surveillance.18,19 In Thailand, Thai VigiBase was initiated in 1984, which is the
national spontaneous reporting database regulated by the Health Product Vigilance Center. Health
professionals and marketing authorization holders in the public and private sectors submit the
reports of ADRs that are identified throughout the country.16 Thai VigiBase accepts only a valid
report according to the documentation grading criteria outlined by the Thai Food and Drug
Administration. The minimum data needed for a valid report include an identifiable patient, an
identifiable sender, at least one suspect drug, and at least one adverse event.20 Thai VigiBase
revealed that the second highest ADR was caused by ibuprofen in 2019.10 However, very little
is known about the characteristics of ADRs among NSAID users in Thailand. This study aimed
to analyze the characteristics of ADRs due to NSAIDs using the reports submitted to Thai
VigiBase from 2015 to 2019. ...

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References End

Nagoya J. Med. Sci. 85. 668–681, 2023

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