Drug Safety Alert: IPC Flags Adverse Reactions linked to Tranexamic acid and Metoclopramide

This came after a preliminary analysis of adverse drug reactions (ADRs) from the Pharmacovigilance Programme of India (PvPI) database.

Tranexamic acid is a synthetic derivative of lysine used as an antifibrinolytic in the treatment and prevention of major bleeding. Tranexamic acid competitively and reversibly inhibits the activation of plasminogen via binding at several distinct sites, including four or five low-affinity sites and one high-affinity site, the latter of which is involved in its binding to fibrin. The binding of plasminogen to fibrin induces fibrinolysis—by occupying the necessary binding sites, tranexamic acid prevents this dissolution of fibrin, thereby stabilizing the clot and preventing hemorrhage.

The alert noted that tranexamic acid is indicated for the treatment of abnormal bleeding in which local hyperfibrinolysis is considered to be involved, such as pulmonary hemorrhage, epistaxis, renal bleeding, or abnormal bleeding during or after prostate surgery. It is also indicated for managing hemorrhage, or the risk of hemorrhage, in cases of increased fibrinolysis associated with hereditary angioneurotic edema.

In addition, the drug is used for the treatment of excessive bleeding in patients with hemophilia during and after tooth extraction, for the management of menorrhagia, and for the prevention of oral hemorrhage in anticoagulant-treated patients undergoing oral surgery.

Following a preliminary analysis of adverse drug reactions (ADRs) from the PvPI database, it has been reported that tranexamic acid may cause nasal congestion—a condition characterized by a blocked or stuffy nose resulting from swelling and inflammation of the nasal tissues due to increased blood flow and fluid accumulation.

Metoclopramide is an antiemetic agent and dopamine D2 antagonist used in the treatment of gastroesophageal reflux disease, prevention of nausea and vomiting, and stimulation of gastric emptying.

Metoclopramide causes antiemetic effects by inhibiting dopamine D2 and serotonin 5-HT3 receptors in the chemoreceptor trigger zone (CTZ) located in the area postrema of the brain. Administration of this drug leads to prokinetic effects via inhibitory actions on presynaptic and postsynaptic D2 receptors, agonism of serotonin 5-HT4 receptors, and antagonism of muscarinic receptor inhibition. This action enhances the release of acetylcholine, causing increased lower esophageal sphincter (LES) and gastric tone, accelerating gastric emptying and transit through the gut. Metoclopramide antagonizes the dopamine D2 receptors. Dopamine exerts a relaxant effect on the gastrointestinal tract through binding to muscular D2 receptors.

The alert noted that metoclopramide is indicated to restore normal coordination and tone to the upper digestive tract and relieve symptoms of gastroduodenal dysfunction, including heartburn, dyspepsia, nausea and vomiting associated with such conditions as reflux, esophagitis, gastritis, duodenitis, and hiatus hernia, and it is also indicated for the treatment of nausea and vomiting.

Following a preliminary analysis of adverse drug reactions (ADRs) from the PvPI database, it has been reported that metoclopramide may cause tachycardia, a medical condition where the resting heart rate is consistently above 100 beats per minute.

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 and Family Welfare, has advised healthcare professionals, patients, and 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 reactions are encountered, please report to the NCC-PvPI, IPC, by filling of Suspected Adverse Drug Reactions Reporting Form/Medicines Side Effect Reporting Form for Consumers (http://www.ipc.gov.in), through Android Mobile App "ADR PvPI App" and PvPI Helpline No. 1800-180-3024 (toll-free)."

To view the official notice, click the link below:

https://medicaldialogues.in/pdf_upload/drugsafetyalertaugust252025-300009.pdf