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, in its ‘preliminary analysis’ has found that the drug Esomeprazole elevates the hormone prolactin to levels that are considered abnormal.
According to the drug safety alert issued by IPC, seen by News18, Esomeprazole is labelled as a “suspected drug” which may react adversely to cause “hyperprolactinemia”.
“The preliminary analysis of Adverse Drug Reactions (ADRs) from the PvPI database revealed the following…,” the notification said while pointing at ‘hyperprolactinemia’.
Hyperprolactinemia is a condition where a person has higher-than-normal levels of prolactin hormone in the blood. The condition can cause infertility, increased risk of bone fractures due to bone loss, vision loss, acne, excessive body and facial hair growth, and decreased muscle mass among several other side effects.
The drug, which is manufactured by top drug makers — including Sun Pharma, Torrent, Pfizer, Cipla and Lupin — is used in the treatment of gastroesophageal reflux disease (GERD), Zollinger-Ellison syndrome and peptic ulcer disease.
Esomeprazole, classified as a proton pump inhibitor (PPI), functions by diminishing stomach acid production, thereby providing relief from indigestion and heartburn associated with excess acidity.
“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.
“If, such reaction is encountered, please report to the NCC-PvPL, IPC by filling out suspected adverse drug reactions reporting form…”
Given in drug combo to counter known side-effects: Experts
Doctors prescribe Esomeprazole to treat conditions where there is too much acid in the stomach which causes problems, including acid reflux and ulcers.
Dr Mahesh Gupta, senior consultant, medical gastroenterology at Delhi’s Dharamshila Narayana Superspeciality Hospital, said the alert regarding Esomeprazole and the potential for hyperprolactinemia is a “significant development in drug safety”.
“Hyperprolactinemia can have a wide range of adverse effects on health, including disruptions in menstrual cycles, sexual dysfunction, and even bone health. Both doctors and patients need to take this advisory on adverse drug reactions very seriously.”
For doctors, Gupta said, it calls for monitoring the patients who have been prescribed Esomeprazole. “We must now be vigilant about the potential for this adverse drug reaction. Those who are taking this medicine should immediately report any unusual symptoms or changes in their health to a doctor. Patient safety is paramount and this notification underscores this fact only.”
According to Dr Anoop Misra, an endocrinologist and executive chairman at Fortis C-DOC Hospital, such drugs are generally prescribed in combination with other medicines to counter their side effects. “Esomeprazole alone may have such potential but usually such drugs are given with Domperidone which increases prolactin.”
Domperidone promotes gut movement, whereas Esomeprazole inhibits stomach acid secretion.
Dr Praveen Sharma, senior consultant at the Institute Of Liver Gastroenterology and Pancreatic Biliary Sciences at Sir Gangaram Hospital, agreed that the drug presently is given in combination with Domperidone. He also added that “short-term use of this product does not cause any such concern”.
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