The Indian Pharmacopoeia Commission (IPC), through its recently drug safety alert for September has cautioned the doctors that Esomeprazole, used for the treatment of Gastroesophageal reflux disease (GERD), can be linked with a drug reactions (ADRs) named Hyperprolactinaemia.
Following this, it has asked the healthcare professionals to diligently monitor the potential occurrence of ADR in case prescribing the said drug.
This came after a preliminary analysis of 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.
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.
Hyperprolactinemia is marked by abnormally high levels of the hormone prolactin (which stimulates breast milk production during and after pregnancy) in the blood.
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 PvPI toll free helpline No. 1800-180-3024.