Drug Safety Alert: Indian Pharmacopoeia Commission Flags ADR Linked To GERD drug Esomeprazole
New Delhi: The Indian Pharmacopoeia Commission (IPC), through its recently issued drug safety alert for the month of September, has revealed that Esomeprazole, indicated for the treatment of Gastroesophageal reflux disease (GERD), is linked with adverse drug reactions (ADRs) named Hyperprolactinaemia.
In connection to the above, the Indian Pharmacopoeia Commission (IPC) has cautioned healthcare professionals to diligently monitor the potential occurrence of Adverse Drug Reactions (ADRs) when administering Esomeprazole.
This came after a preliminary analysis of Adverse Drug Reactions (ADRs) from the Pharmacovigilance Programme of India (PvPI) database.
Esomeprazole is a proton pump inhibitor used to treat GERD, reduce the risk of NSAID-associated gastric ulcers, eradicate H. pylori, and treat conditions causing gastric acid hypersecretion.
Esomeprazole exerts its stomach acid-suppressing effects by preventing the final step in gastric acid production by covalently binding to sulfhydryl groups of cysteines found on the (H+, K+)-ATPase enzyme at the secretory surface of gastric parietal cells. This effect leads to inhibition of both basal and stimulated gastric acid secretion, irrespective of the stimulus. As the binding of esomeprazole to the (H+, K+)-ATPase enzyme is irreversible and a new enzyme needs to be expressed in order to resume acid secretion, esomeprazole's duration of antisecretory effect that persists longer than 24 hours.
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