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Meftal & DRESS Syndrome: IPC Updates

M3 India Newsdesk Dec 13, 2023

Mefenamic acid, a commonly used analgesic, has been associated with severe allergic reactions, including DRESS syndrome, prompting a drug safety advisory from the Indian Pharmacopoeia Commission. The advisory emphasises vigilant monitoring for adverse reactions and reporting any incidents promptly.

Mefenamic acid is one of the most common analgesics used in clinical practice. The popular painkiller, mefenamic acid, has been linked to severe allergic responses including the DRESS syndrome, which damages internal organs, according to a drug safety advisory issued by the Indian Pharmacopoeia Commission (IPC). 

Mefanamic acid is an anti-inflammatory, nonsteroidal medication. It is an inhibitor of COX-1 and COX-2 that is non-selective. Mefenamic acid is structurally linked to meclofenamate and is an N-substituted derivative of phenylantharanilic acid (Fenamate). Mefenamic acid has analgesic, antipyretic and anti-inflammatory efficacy. 

The alert advises healthcare professionals, patients, and consumers to carefully monitor the likelihood of the aforementioned adverse drug reactions (ADR) linked with the use of the stated suspected medicine. While several medical professionals acknowledged that they had not seen any serious adverse responses in their practice, they did issue a warning that each patient might respond differently to the medication.

Overdosing on the medicine without proper regulation is the main issue. Although mefenamic acid is a prescription drug, it is commonly used in India for several ailments, such as headaches, muscular and joint pain, menstruation discomfort, and high fever in children. Available under the brand names Meftal, Mefkind, Mefanorm, and Ibuclin P, mefenamic acid is comparable to drugs such as aspirin and ibuprofen. 

What is the word of caution? 

The IPC, an autonomous institution within the Ministry of Health and Family Welfare, establishes national drug regulations. It changes the specifications of frequently used medications on a regular basis. 

IPC said in its advisory that users and healthcare providers should actively watch the likelihood of adverse drug reactions while using the medication. 

It is highly recommended that patients and healthcare providers regularly monitor the potential for the indicated adverse medication response while using mefenamic acid. 

The notification advised that if such a response is experienced, individuals should report the incident to the PvPI's national coordination centre, which is overseen by the commission. This may be done by submitting a form on the website www.ipc.gov.in, using the ADR PvPI Android mobile app, or by calling the PvPI hotline at 1800-180-3024. 

The IPC advises being alert for any signs of DRESS syndrome. If such responses are seen, people are urged to report the issue as soon as possible to the PvPI's national coordinating centre. The IPC's official website (www.ipc.gov.in), the ADR PvPI Android mobile app, or the PvPI hotline number 1800-180-3024 may all be used to file reports. 

So, what exactly is DRESS syndrome? 

A severe, unique, and idiosyncratic drug response, or DRESS syndrome, is a reaction that only happens in a tiny fraction of individuals taking the medication and is not related to any of the drug's recognised pharmacological features. The extended latency period of the DRESS syndrome refers to the length of time that elapses between drug exposure and the onset of symptoms.  

It might take up to eight weeks for the DRESS syndrome symptoms to manifest after taking the medication. Based on information from the US National Institutes of Health (NIH), the symptoms include fever, rash, lymphadenopathy, or enlargement of the lymph nodes, and eosinophilia, or an excess of eosinophils in the body.  

Using medications carefully is essential to avoiding this serious side effect. 

It's important to understand that mefenamic acid has been related to DRESS syndrome, which may produce symptoms including skin rash, high fever, enlarged lymph nodes, and problems with internal organs. This is especially important in light of the IPC's recent drug safety advisory on this medicine. For patient safety, the notice places a strong focus on diligent monitoring and reporting of adverse medication reactions. When taking mefenamic acid, get immediate medical advice from a physician to discuss possible alternatives. 

Aware of potential gastrointestinal problems 

Another concern relates to digestive problems. Mefenamic acid use for an extended period of time may raise the risk of stomach ulcers, bleeding, and associated problems. Caution should be taken by those who have a history of gastrointestinal issues, are taking other NSAIDs or anticoagulants at the same time or both. 

Mefenamic acid has also been linked to possible negative effects on the cardiovascular system. Mefenamic acid is one of the NSAIDs that some studies indicate may be associated with a higher risk of cardiovascular events, especially in those who already have heart problems. Renal problems have also been mentioned by several specialists as a possible mefenamic acid adverse effect. 

Healthcare providers stress the need to use mefenamic acid responsibly and intelligently in light of these concerns. Before beginning or continuing mefenamic acid medication, patients are recommended to speak with their healthcare providers, particularly if they have a history of gastrointestinal, cardiovascular, or renal problems. 


Disclaimer- The views and opinions expressed in this article are those of the author and do not necessarily reflect the official policy or position of M3 India.

About the author of this article: Dr Monish Raut is a practising super specialist from New Delhi.

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