Drug Safety Alert: Indian Pharmacopoeia Commission Flags ADR Linked To GERD drug Esomeprazole

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.

The alert noted that esomeprazole is indicated for the treatment of GERD, erosive reflux esophagitis, and prevention of relapse of esophagitis and it helps in the eradication of H. Pylori associated peptic ulcer.

In addition, the alert highlighted that esomeprazole is used for the treatment of gastric and duodenal ulcers, Zollinger-Ellison syndrome.

Following the preliminary analysis of Adverse Drug Reactions (ADRs) from the PvPI database, it is reported that Esomeprazole can lead to Hyperprolactinaemia.

Hyperprolactinemia is marked by abnormally high levels of the hormone prolactin (which stimulates breast milk production during and after pregnancy) in the blood.

Now, as per the issued drug safety alert, the following suspected drug is associated with the ADR as given below:

In light of the above, the Indian Pharmacopoeia Commission, Ministry of Health & Family Welfare, has advised Healthcare Professionals, Patients/Consumers to closely monitor the possibility of the above ADRs associated with the use of the above-suspected drugs.

Further, the safety alert added, "If such reaction is encountered, please report to the NCC-PvPI, IPC by filling out Suspected Adverse Drug Reactions Reporting Form/Medicines Side Effect Reporting Form for Consumer (http://www.ipc.gov.in), through Android Mobile App "ADR PvPI App" and PvPIHelpline No. 1800-180-3024 (Toll-Free)."