The Indian Government recently issued a safety alert on one of the safest anti-inflammatory drugs, mefenamic acid based on one of the rarest side-effects, virtually unrecorded by Indian pharmacovigilance.
In this brilliant article, @verma_shivani12 reports for @TheKenWeb on why this alert was illogical, irrational, fearmongering and…just weird.
With inputs from me (based on my evidence-based post on mefenamic acid) and @DrCuterus
Bottom line: Mefenamic acid, popularly known by the brand name “Meftal” is safe to consume for its recommended uses (so women, please dont worry). The Indian Government is doing strangely confusing things in healthcare and public health that one cannot make out any meaning from it.
Free to read:
How Indian women’s go-to drug, Meftal Spas, became a victim of its own popularity
the-ken.com/story/how-indi…
How Indian women’s go-to drug, Meftal Spas, became a victim of its own popularity
A government safety alert has confused consumers, baffled health professionals, and impacted sales of the most-prescribed drug to treat menstrual cramps
12 Jan 2024 / 12 min read
Shivani writes about the impact of business, technology, and public policy on society.READ SUMMARY
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Disprin is known for alleviating headaches. There’s Dolo 650 to fight off fever. Then, there is Meftal Spas for easing period pains—a popular choice among countless Indian women.
However, recent safety concerns have cast a shadow over the antispasmodic prescription drug, which is largely available over the counter.
On 30 November 2023, the Indian Pharmacopoeia Commission (IPC), an autonomous institution under the Ministry of Health and Family Welfare (MoHFW), issued a drug safety alert on mefenamic acid—one of the two main components in the Blue Cross Laboratories-manufactured Meftal Spas.
The advisory urged consumers and healthcare professionals to remain vigilant regarding a potential adverse drug reaction (ADR) called DRESS syndrome (Drug Reaction with Eosinophilia and Systemic Symptoms).
This has dissuaded even some of Meftal Spas’ regular customers, like Nihan Parveen from Delhi. The 27-year-old has been consuming the tablet since 2018 but opted against taking it last Saturday when she was suffering from severe menstrual cramps. “This time, I didn’t take any medicines and had to bear the pain.”
Her decision to discontinue taking the medication was based on news reports that inaccurately indicated the advisory was on Meftal Spas and not mefenamic acid. Another consumer of the drug, Varsha Patel, concurred that she, too, has largely been exposed to similar articles.
Several media reports stated that the advisory was issued on Meftal Spas, even as other antispasmodic medicines such as Mefkind-Spas and Cyclopam-MF contain the same combination of salts—dicyclomine and mefenamic acid. What’s more, data by market research firm IQVIA shows there are over 70 brands that use this combination, registering sales of about Rs 176 crore ($21.2 million) for the year ended March 2022. Meftal Spas has captured 87% of this market.
“Every other girl who’s menstruating knows about Meftal Spas. Women have been using it for ages”
— AKTA BAJAJ, SENIOR CONSULTANT AND HEAD-OBSTETRICS GYNAECOLOGY, UJALA CYGNUS HOSPITAL, DELHI
The over 40-year-old medication has been central to Blue Cross establishing itself as a leading research-based pharmaceutical company in India. Revenue from Meftal products, which also include Meftal P and Meftal Forte, was over Rs 250 crore ($30.1 million) for the year ended March 2023.
An executive from the Mumbai-based company told The Ken that the market leader in antispasmodic medicine will likely earn over Rs 300 crore ($36.2 million) in annual sales from Meftal products in the year ended March 2024. They and several others mentioned in the story declined to be named as they either weren’t authorised to speak to the media or didn’t want to comment on the subject publicly.
Composition // Founded in 1980 by chairman N H Israni, Blue Cross manufactures products in segments like pain management, antispasmodics, gastrointestinal ailments, diabetes, cardiovascular disease management, and cough and cold remedies. Meftal and TUSQ, a cough syrup, are its most popular brands
The IPC advisory on mefenamic acid has also turned some pharmacies, doctors, and hospitals cautious. The Ken’s conversations with five consumers, nine doctors, including pharmacologists, and 12 pharmacists suggest a material impact on sales of Meftal Spas due to misinformation.
Few pharmacies are already witnessing a dip in their Meftal Spas sales, and a major chain of private hospitals has recalled the drug and is no longer prescribing the medication to its patients, a person familiar with the matter told The Ken.
Health professionals, however, are now raising qualms over the process behind the issuance of such advisories. They’re calling for more disclosures from IPC on matters like the number of ADRs, the dosage taken, and the severity of the reaction, among other advisory-linked factors.
These transparency issues are likely to rumble on in the face of the IPC mefenamic acid safety warning, which led to Meftal Spas becoming a victim of its own market dominance.
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Price for popularity
Launched in 1981, Meftal Spas is a relatively economical medicine—a strip of 10 tablets costs Rs 50 ($0.60). But above all, “it’s the best drug out there to treat menstrual cramps,” said Dr Kruthi Adidum, pursuing an MS (OB-GYN) from Bengaluru’s Vydehi Institute of Medical Sciences. She has been prescribing the medicine to her patients for over two years.
Medical doctor and health educator Tanaya Narendra added that the presence of dicyclomine, which stops the spasms or cramps, in Meftal Spas differentiates it from other standard drugs with mefenamic acid.
All pharmacists The Ken spoke to indicate that Meftal Spas is the most, and sometimes, the only drug sold and prescribed by doctors for menstrual cramps. Other alternatives—which on average have half the sales of Meftal Spas each—include Drotin-M, Ibuprofen, and Cyclopam, priced at Rs 213 ($2.57), Rs 70 ($0.84), and Rs 55 ($0.66) for 10 tablets, respectively.
However, after several media reports on Meftal Spas, consumers are alarmed. For instance, Parveen has resorted to hot-water bags. Patel is seeking a substitute for the medicine like many others, who either question its efficacy or are hesitant to consume it.
“I got hundreds of direct messages and replies after I tweeted about this. While some thanked me for the information, others already taking the course questioned whether they could continue to take the medicine,” liver-disease specialist Cyriac Abby Philips, popularly known as the “liver doc”, told The Ken.
His post on X (formerly Twitter) on IPC’s advisory garnered over 357,000 views. Narendra, who goes by the moniker Dr Cuterus, shared similar opinions on an Instagram reel.
Blue Cross, on 9 December, issued a statement, attempting to clarify any misunderstanding regarding the IPC safety alert on mefenamic acid. However, that has failed to stem the uncertainty.
“A few customers asked me about the medicine and whether it has been banned,” said a store manager at pharmacy chain Wellness Forever in Delhi NCR. They claimed that the store is still witnessing regular sales of Meftal Spas, though.
All but one of the Apollo pharmacies in Delhi NCR and Bengaluru The Ken reached out to also reported regular sales.
An Apollo Pharmacy in Bengaluru informed that it sold over 200 strips of Meftal Spas in December 2023 but only 38 strips in the first ten days of January. A Wellness Forever store in Karnataka sold only three strips of the medicine compared to eight strips of Cyclopam after the advisory.
Besides, some stores of e-pharmacy Netmeds in Bihar and Delhi NCR have also witnessed a 30% dip in Meftal Spas’ sales. Alternatives like Ibuprofen and Cyclopam saw a rise of 10% in their sales, one Netmeds pharmacist said. “This may increase further as long as people are not trusting Meftal Spas.”
They all attributed any decline in Meftal Spas’ sales to IPC’s advisory.
In response to The Ken’s queries, IPC said that “it hasn’t issued the alert with any specific brand manufactured by a particular pharmaceutical company” and that “the media wrongly captured it.”
And if pharmacies weren’t enough, a major chain of private hospitals went a step further and pulled Meftal Spas from its shelves. “The hospital is now prescribing alternatives to mefenamic acid,” a person with direct knowledge of the matter said while adding that it’s a general procedure if a drug alert comes up. However, another person familiar with the situation indicated that the drug is still available, but only on a prescription basis.
In response to The Ken’s queries, the private hospital chain said that it hasn’t recalled Meftal Spas as it isn’t banned by the Indian government.
The Ken checked with other hospitals such as Prayagraj’s Abhilasha Hospital & Fertility Center, Rajagiri Hospital, Kochi and Ujala Cygnus Hospital, Delhi, Kailash Healthcare Ltd, Noida and understands that they haven’t recalled the drug and continue to prescribe Meftal Spas.
A detailed set of queries to ascertain the impact of IPC’s advisory on Blue Cross was sent to the manufacturer on 6 January but went unanswered.
The IPC advisory on mefenamic acid—used globally for over 60 years—has drawn closer scrutiny from some industry insiders. They question the criteria, data used, and transparency of the government ministry in issuing safety alerts.
Cause for alarm
Mefenamic acid, a nonsteroidal anti-inflammatory drug (NSAID), not only alleviates mild to moderate pain in menstrual cramps but also addresses conditions like rheumatoid arthritis, osteoarthritis, inflammation, and fever.
“The fact that NSAIDs, including mefenamic acid, can cause DRESS syndrome—an extremely rare adverse event—is not new,” said Philips, who added that it’s even rarer for the mefenamic-acid group to cause DRESS.
“I am unsure why the names mefenamic acid and Meftal Spas have come into the picture—it’s classical misinformation and [an example of] how one shouldn’t put out an advisory.”
— LIVER-DISEASE SPECIALIST CYRIAC ABBY PHILIPS, POPULARLY KNOWN AS THE LIVER DOC
Narendra echoed Philips’ concerns, saying the news was blown out of proportion and that there hasn’t been a single case of DRESS syndrome reported in India due to mefenamic acid. Antiepileptic drugs such as carbamazepine, phenytoin and phenobarbitone are the most common medications that are associated with DRESS syndrome.
Given these factors, there are growing doubts over the methodology used by IPC to issue safety warnings.
Launched by the MoHFW in 2010, the Pharmacovigilance Programme of India (PvPI) by IPC maintains and develops the pharmacovigilance database of all suspected severe adverse reactions to medicines observed. There are over 650 Adverse drug reaction Monitoring Centres (AMCs), including medical colleges and hospitals (government and private), which send reports of ADRs to IPC, a former IPC executive told The Ken.
“Once the reports are received, they are processed by physicians, pharmacists, etc. Then, a signal is generated, followed by issuing a drug safety alert,” they added.
Further, according to Ankit Gaur, coordinator of the medical device adverse event monitoring centre at Kailash Healthcare Ltd, consumers and healthcare professionals can also report ADRs to IPC. Usually, more than one report is required to generate a signal, depending on the event’s seriousness and the information’s quality.
But apart from the drug name and ADR, the IPC advisory didn’t provide other pieces of key information, like total ADRs reported, their origin, and severity of the reaction, etc.
In its response to The Ken, IPC said that “the PvPI has received Individual Case Safety Reports (ICSRs) for mefenamic acid-associated DRESS Syndrome from its AMCs across the country” but didn’t specify the locations and the total number of cases.
It added that the drug-safety alert is “based on the qualitative and quantitative evaluation [of] ICSRs” and that input from medical experts is also taken.
Meanwhile, Adidum calls for IPC advisories to be more specific. “It only names DRESS syndrome and the drug name. But it could be caused because of anything. For instance, what if someone was also taking antiepileptic drugs in combination with mefenamic acid?”
Also, Gaur believes that the advisory may have only come now because there were no established systems to report ADRs earlier. However, he adds that mefenamic acid is completely safe if taken under the supervision of a medical practitioner. “These are very uncommon side effects, which only some consumers may develop,” said the clinical pharmacologist, adding that the advisory was only to inform the public about the safer use of the drug.
While the advisory is a reminder to consume the drug under the guidance of a doctor, the adverse effect of the safety alert fell upon Meftal Spas due to its popularity among Indian women.
“It was completely media-generated,” said the former IPC executive. “A common person wouldn’t understand what mefenamic acid is. So, several reports used Meftal Spas’ name to make the general public aware.”
Unless the IPC adds specificity to advisories and discloses critical input related to the issuance of a safety alert, other popular drugs, such as Combiflam and Crocin, face a real threat of undergoing similar misinformation-linked woes to that of Meftal Spas.
Knock nock 
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