An observational study on adverse drug reaction profile in patients on long-term treatment with proton pump inhibitors

ABSTRACT

Background: Proton pump inhibitors (PPI) are most commonly prescribed medications in the world which are highly effective drugs in treatment of upper gastrointestinal disorders, but there are concerns regarding its long term use. Aim and Objective: To assess the pattern of reported adverse drug reactions (ADR) in patients with long term use of PPI and to estimate the frequency of adverse drug effects. Materials and Methods: A study conducted as an observational study among 100 consecutive patients who attended the medical-gastro inpatient and outpatient department on treatment with PPI for more than 4 months, according to inclusion and exclusion criteria. After attaining the written informed consent, data regarding patient’s demographic details, occupational status, addictions, co-morbidities, and lab investigations were recorded in pre-prepared proforma after interviewing the patient and referring the case sheet. Details including PPI used and per day dose of the drug with any ADR developed were noted. Data collected were analyzed using appropriate statistical method. Categorical variables are expressed as frequency (percentage) and continuous variables as mean (standard deviation). Chi-square test was used to find out the association between PPI and ADR. Results: Out of 100 study participants, 57% case reported ADR which included 19 cases (33.3%) of hypomagnesemia, 8 cases (14%) each of hypocalcemia, and hyperkalemia, 7 cases (12.3%) of anemia, and 5 cases (8.9%) of acute kidney injury. Out of the 57 reported adverse events, 29 (50.9%) were caused by Rabeprazole followed by 18 (31.6%) by Pantoprazole, then Esomeprazole 8 (14%), and least by Omeprazole (3.5%). Conclusion: Long-term use of PPI can lead to various ADR which requires the withdrawal of drug. Since PPIs are easily available without prescriptions, self-medication with PPIs are increasing alarmingly. With every antibiotic one PPI is always prescribed, as a result, there is irrational use of PPIs which is of concern and requires attention. These adverse events could be reduced by preventing self-medication of long duration and reducing the irrational prescribing of PPIs. Doctors should be sensitized about the ADRs. The patient should be educated about the long-term adverse effects of PPIs.