Meftal Drug Safety Alert: The Indian Pharmacopoeia Commission under the Union Ministry of Health & Family Welfare has issued a drug safety alert on mefenamic acid, a medicine sold under the brand name Meftal. The drug safety alert was issued on November 30, 2023, because a preliminary analysis conducted by the Pharmacovigilance Programme of India (PvPI), an Indian government organisation which identifies and responds to drug safety problems, revealed some adverse drug reactions caused by mefenamic acid.
It was found to cause drug rash with eosinophilia and systemic symptoms (DRESS) syndrome.
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What is DRESS syndrome?
The DRESS syndrome is a severe, distinct, and idiosyncratic drug reaction, which is an unpredictable reaction that occurs in only a small percentage of patients receiving the drug, and which does not involve known pharmacological properties of the drug. The DRESS syndrome has a prolonged latency period, which means that the period between exposure to the drug and the appearance of symptoms is long.
The symptoms of the DRESS syndrome can start appearing about two to eight weeks after consuming the drug. The symptoms include fever, a wide range of mild-to-severe systemic occurrences, rash, lymphadenopathy, or swelling of the lymph nodes, and eosinophilia, or the presence of too many eosinophils in the body, according to the US National Institutes of Health (NIH).
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The Indian Pharmacopoeia Commission has advised healthcare professionals, patients and consumers to closely monitor the possibility of the occurrence of the DRESS syndrome with the use of mefenamic acid.
People who observe such reactions have been asked to report to the National Coordination Center under the PvPI by filling out the Suspected Adverse Drug Reactions Reporting Form, or the Medicines Side Effect Reporting Form for Consumers.
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The form can be filled out through an Android mobile application called ADR PvPI.
Mefenamic acid is used to treat rheumatoid arthritis, dysmenorrhoea, inflammation, dental pain, osteoarthritis, mild to moderate pain, and fever.
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