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IPC Alert: A Deep Dive into Mefenamic Acid and its reactions

Mefenamic acid has been a key ingredient in painkillers, with meftal being a prominent brand. Understanding its importance is crucial in evaluating the impact of the IPC alert.

The Health Master

January 16, 2024

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Indian Pharmacopoeia Commission IPC — IPC

Table of Contents

Last Updated on January 22, 2024 by The Health Master

IPC Alert

In the backdrop of a caution by the Indian Pharmacopoeia Commission (IPC) against mefenamic acid, a major component of painkiller meftal, the medicine’s manufacturer said the IPC alert seeks to advise doctors and patients to monitor the possibility of an adverse reaction of the drug.

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A. Background of the IPC alert

The Indian Pharmacopoeia Commission (IPC) raised concerns about mefenamic acid, a crucial element in the painkiller meftal, urging caution among medical practitioners and patients.

B. Significance of mefenamic acid in painkillers

Mefenamic acid has been a key ingredient in painkillers, with meftal being a prominent brand. Understanding its importance is crucial in evaluating the impact of the IPC alert.

C. Purpose of the manufacturer’s response

Blue Cross Laboratories, the manufacturer of meftal and meftal-spas, responded to the IPC alert, aiming to reassure both doctors and patients regarding the safety and quality of their products.

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II. IPC Alert on Mefenamic Acid

A. Date and details of the IPC alert

On November 30, the IPC issued an alert, revealing a preliminary analysis of adverse drug reactions from the Pharmacovigilance Programme of India (PvPI) database related to mefenamic acid.

B. Adverse reactions reported in the PvPI database

The alert focused on drug reactions with eosinophilia and systemic symptoms (DRESS) syndrome, prompting a need for close monitoring by healthcare professionals and patients.

C. Focus on drug reactions with eosinophilia and systemic symptoms (DRESS) syndrome

The IPC alert specifically highlighted the rare DRESS syndrome as an adverse reaction associated with mefenamic acid, sparking concerns within the medical community.

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III. Blue Cross Laboratories’ Statement

A. Overview of Blue Cross Laboratories

Blue Cross Laboratories, the pharmaceutical company behind meftal and meftal-spas, issued a statement in response to the IPC alert, aiming to address concerns and provide clarity.

B. Assurance on the safety, efficacy, and quality of meftal and meftal-spas

The company emphasized that the IPC alert does not impact the safety, efficacy, and high quality of their brands, supported by robust clinical studies.

C. Emphasis on clinical studies supporting the brands

Highlighting the importance of clinical studies, Blue Cross Laboratories sought to reinforce the credibility of meftal and meftal-spas in the market.

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IV. Monitoring and Reporting Adverse Reactions

A. Guidelines for healthcare professionals and patients

The IPC alert prompted guidelines for healthcare professionals and patients, stressing the need for vigilant monitoring of adverse drug reactions.

B. Reporting process to the national coordination centre

In case of encountering any adverse reaction, the alert advised people to report the matter to the national coordination centre of the PvPI through designated channels.

C. Involvement of the Pharmacovigilance Programme of India (PvPI)

The PvPI’s role in monitoring and addressing adverse drug reactions was underscored, emphasizing the collaborative effort to ensure drug safety.

V. Global Usage of Mefenamic Acid

A. Geographical areas where mefenamic acid is prescribed

Apart from India, mefenamic acid, under the brand names meftal and meftal-spas, has been prescribed in countries like the USA, the UK, Japan, etc.

B. Duration and scale of usage

With a history spanning more than four decades, mefenamic acid has seen billions of doses administered globally, benefiting millions of patients.

C. Positive impact on millions of patients

Blue Cross Laboratories highlighted the positive impact of mefenamic acid, showcasing its widespread usage and benefits to a large patient population.

VI. Understanding DRESS Syndrome

A. Explanation of DRESS syndrome

DRESS syndrome, the adverse reaction mentioned in the IPC alert, was explained as a very rare event documented in medical literature globally.

B. Rarity of the event in medical literature

Blue Cross Laboratories emphasized the rarity of DRESS syndrome, putting it into context within the broader landscape of documented adverse reactions.

C. Known adverse reactions of various drugs

The statement clarified that DRESS syndrome is a known adverse reaction associated with many drugs, emphasizing the importance of considering individual patient factors.

VII. Doctor’s Role in Prescribing Mefenamic Acid

A. Importance of patient history in prescribing

The company highlighted the role of doctors in prescribing mefenamic acid, emphasizing the significance of considering patient history to minimize the risk of

adverse reactions.

B. Individual factors considered by doctors

In prescribing any medicine, doctors take into account individual factors, tailoring treatment plans to mitigate the risk of adverse reactions based on patient-specific characteristics.

C. Reducing the risk of adverse reactions

The statement from Blue Cross Laboratories underscored the proactive measures taken by healthcare professionals to reduce the risk of adverse reactions when prescribing mefenamic acid.

VIII. Conclusion

A. Recap of key points

In conclusion, the article summarized the key points, including the IPC alert, Blue Cross Laboratories’ response, and the global usage and positive impact of mefenamic acid.

B. Emphasis on the balance between benefits and risks

The importance of striking a balance between the benefits of mefenamic acid and the potential risks associated with rare adverse reactions was highlighted.

C. Encouragement for responsible usage and reporting

The conclusion encouraged responsible usage of mefenamic acid, urging both healthcare professionals and patients to report any adverse reactions through the prescribed channels.

Disclaimer: This article contains information derived from the source mentioned below. Our team utilized an AI language model to rewrite and present the news or article in a unique format.

FAQs

Is mefenamic acid safe for use despite the IPC alert?
- Blue Cross Laboratories assures the safety, efficacy, and high quality of meftal and meftal-spas, supported by extensive clinical studies.
What is DRESS syndrome, and how rare is it?
- DRESS syndrome is a rare adverse reaction documented in medical literature globally. Blue Cross Laboratories clarified its rarity and association with various drugs.
How long has mefenamic acid been in use globally?
- Mefenamic acid, under different brand names, has been prescribed globally for over four decades, with billions of doses administered and benefiting millions of patients.
What should healthcare professionals do in case of adverse reactions?
- Healthcare professionals are advised to closely monitor and report any adverse reactions associated with mefenamic acid to the national coordination centre of the PvPI.
How can patients report adverse reactions?
- Patients should report adverse reactions to the national coordination centre of the PvPI by filing a form on the IPC website or through the android mobile app ADR PvPI and PvPI Helpline number 1800-180-3024.