Proton pump inhibitors (PPIs) are the most potent gastric acid–suppressing agents used for preventing nonsteroidal anti-inflammatory drug (NSAID)–induced ulceration and for treating peptic ulcers and other acid-related conditions.1,2 The first PPI drug to be developed was omeprazole, followed by lansoprazole, pantoprazole, rabeprazole, esomeprazole, and others.2
Even though PPIs are commonly used in clinical practice, there is a limited number of studies on cutaneous adverse reactions from PPIs, and most of these are case reports.3-14 Therefore, the purpose of this case-control study is to demonstrate the pattern of cutaneous reactions relating to PPI usage and to evaluate the risk of developing PPI drug eruptions among adult patients.
Patients and Study Design
This retrospective study on cutaneous reaction from PPIs was approved by the Siriraj Institute Review Board, Siriraj Hospital, Mahidol University, and performed at Siriraj Hospital, a medical school and tertiary referral center in Bangkok, Thailand.
Cutaneous adverse reactions from PPIs, with or without systemic symptoms, were diagnosed and reported to the Adverse Drug Reaction (ADR) Center by attending physicians and dermatologists. Well-trained and experienced ADR Center pharmacists and dermatologists then reviewed the events and assessed the causative agents based on history, clinical manifestation, and laboratory data. The drug imputability of each case was classified under six levels according to the World Health Organization (WHO) Uppsala Monitoring Centre guidelines.15 The assessments were as follows:
- Certain: The adverse reaction occurred during the time period corresponding to the drug usage but cannot be explained by any preexisting disease, concomitant drug use, or other chemical substance. Furthermore, the adverse reaction obviously improved or disappeared after the patient stopped using the drug, but recurred when drug therapy was reinstituted. Thus, the pharmacological mechanism or the adverse event is clearly evident as an explanation.
- Probable: The adverse reaction occurred during the time period corresponding to the drug usage and is probably not associated with any preexisting disease, concomitant drug use, or other chemical substance. The adverse reaction improved or disappeared after the patient stopped using the drug. However, information about repeat drug use may not be available.
- Possible: The adverse reaction occurred during the time period corresponding to the drug usage but may be ex-
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