NEW DELHI: India’s drug safety authority has raised fresh concerns over two commonly prescribed medicines, warning doctors and patients to watch for potentially serious side effects.
The Indian Pharmacopoeia Commission (IPC), an autonomous body under the Ministry of Health & Family Welfare, has issued safety alerts on Tranexamic Acid and Metoclopramide, according to the IPC’s drug safety alert report seen by Mint.
The move follows an analysis of adverse drug reactions (ADRs) collected under the Pharmacovigilance Programme of India (PvPI), the country’s national drug safety monitoring system, during August.
Tranexamic Acid—prescribed to control excessive bleeding in conditions such as menorrhagia, nosebleeds, and post-surgery recovery—has been linked to nasal congestion. While congestion is usually not life-threatening, it can cause significant discomfort and may sometimes indicate more severe underlying problems.
The drug’s global market was estimated at over $80 million in 2022 and is projected to exceed $100 million by 2029.
Metoclopramide, used to treat gastro-duodenal dysfunction and relieve heartburn, nausea, and vomiting, has been associated with tachycardia, or rapid heart rate. Tachycardia can be benign in response to exercise or stress, but when triggered by medication, it can point to underlying complications and, if untreated, lead to heart failure or stroke.
The global market for Metoclopramide was valued at over $1.5 billion in 2024 and is expected to continue growing.
“The purpose of these alerts is to inform healthcare professionals, patients, and consumers about the potential for these side effects. The IPC advises everyone to closely monitor for these ADRs when using the suspected drugs. This is part of a broader public health effort by the PvPI to continuously monitor the safety of medicines in the Indian population,” an official familiar with the matter said.
Queries sent to the health ministry spokesman remained unanswered.
The PvPI programme gathers evidence-based data to support the Central Drugs Standard Control Organisation (CDSCO) in making regulatory decisions. Such alerts are considered an essential tool in pharmacovigilance, a science focused on detecting and analyzing adverse reactions to ensure drug safety.
By collecting reports such as those related to Tranexamic Acid and Metoclopramide, regulators say they can help minimize harm and encourage more prudent use of medicines. The IPC has also provided a helpline number and an online reporting form for suspected ADRs.
An ADR is defined as a harmful and unintended response to a medication at doses normally used for treatment, diagnosis, or prevention of disease. Reactions may range from mild headaches and nausea to severe, life-threatening conditions, making them a persistent public health concern.
In January, the IPC logged 15,284 Individual Case Safety Reports (ICSRs) from ADR Monitoring Centres and pharmaceutical companies.
“Physician reporting of ADRs offers a databank from which other clinicians can learn lessons and result in safer prescribing and better patient counselling. ADR reporting is not only a regulatory function—it’s a shared responsibility of all stakeholders, including physicians, pharmacists, and patients. Active reporting guarantees that medicines not only work but are also safe in actual usage,” said Dr Tushar Tayal, associate director, Internal Medicine, CK Birla Hospital, Gurugram.
Source link