Indian Pharmacopoeia Commission Issues Drug Safety Alert for Esomeprazole Over Hyperprolactinemia Risk
5 Oct 2023 • Pharma standard body Indian Pharmacopoeia Commission (IPC) has issued a drug safety alert for doctors and patients about the use of acid-reflux medicine Esomeprazole, alerting healthcare professionals and patients to closely monitor the side effects of the medicine.
The Pharmacovigilance Program of India (PvPI), which monitors and collects information about adverse drug reactions (ADRs) and adverse events associated with pharmaceutical products, has found out that the drug Esomeprazole elevates the hormone prolactin to levels that are considered abnormal, which may lead to Hyperprolactinemia.
"Healthcare professionals, patients or consumers are advised to closely monitor the possibility of the above adverse drug reaction (ADR) associated with the use of the above-suspected drug," said the IPC alert dated September 27.
According to the drug safety alert issued by IPC, Esomeprazole is labelled as a "suspected drug" which may react adversely to cause hyperprolactinemia.
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