Drug safety alert on Meftal Spas alarms women; doctors advise caution

Late last month, the Indian Pharmacopoeia Commission issued a drug safety alert about mefenamic acid, available under the brand name Meftal Spas, warning that it could trigger allergic reactions like the DRESS syndrome. The drug safety alert advises healthcare professionals, patients, and consumers to closely monitor the adverse drug reactions arising from its use.

Drug reaction with eosinophilia and systemic symptoms (DRESS) is a severe adverse drug reaction characterised by an extensive skin rash, in association with visceral organ involvement, lymphadenopathy (swelling of lymph nodes), eosinophilia (an increase in the number of eosinophils, a type of white blood cells), and atypical lymphocytosis. 

The Meftal Spas over-the-counter pill has been the saviour for many women during their painful periods. However, the drug safety alert, as reported in mainstream media, has caused alarm and anxiety among women who have used it as a pain reliever for menstrual cramps. 

Meghna Mathew, editor and writer, points out that this pill has been a no-brainer for everyone in her family.

“I had just taken Meftal the afternoon before I read the article (on the drug safety alert), and the instant reaction was of fear. While it is understandable that new side effects can be discovered much later, it’s the lack of research into female anatomy and menstruation that is troublesome,” she says. 

Disha Shrivastava, a 44-year-old mother of two boys, 18 and 14 years, suffers from endometriosis, which causes a lot of pain and heavy flow during periods. 

“Sometimes, I find it difficult to move and also feel dizzy. I have used Meftal Spas for a very long time, and I don’t even remember if a doctor prescribed it or not. Maybe someone in the hostel recommended it, and it started that way. I used to take two to three tablets a day when I had severe pain,” she says.

Shrivastava, who runs and cycles long distances, used to take Meftal Spas whenever she had a race. 

“Many times I popped two before the race. For the last 6-7 years, I’ve been using menstrual cups instead of sanitary pads to avoid chafing during my races, and I realised that the period pain has reduced drastically. It’s been a year that I haven’t used the tablet and avoid it to a larger extent,” she adds.

Piyali Guha suffers from polycystic ovarian syndrome (PCOS) that causes delayed periods, severe clotting and pain. She has relied on the drug right from her school days.

“I don’t think I would have been able to survive without Meftal Spas, which reduced the pain. Work from home and period leave have come into the picture only now, but during my early working days it wasn’t possible to take leave on the first day of your period every month. So, for the first two days, Meftal Spas was my bestie. My blackouts were so severe because of pain that I couldn’t attend any meetings without popping one,” she says.

Despite the safety alert, some women feel compelled to continue relying on a drug they have been using for long. 

“I feel it may be years till we see a foolproof alternative, and until then, people who menstruate will have no choice but to take this medication—there simply is no other solace,” says Mathew. 

Aanchal Mahajan, who has been using Meftal Spas for years because of excruciating stomach pain during her periods, says the drug safety caution is quite alarming and wishes to consult a gynaecologist to reassess.

"But without an alternative in sight, I might resort to Meftal Spas again as, so far, I haven’t noticed anything adverse,” she adds.

Exercise caution

Doctors HerStory spoke to say more research is required and advise caution and restraint in the meantime. 

Dr Nirmala Chandrashekar, Senior Consultant, Obstetrics, Gynecology, Gleneagles Global Hospital explains how Meftal Spas, which is a combination of dicyclomine (anti-spasmodic) and mefenamic acid (a non-steroidal anti-inflammatory drug), works. 

“It is a non-steroidal anti-inflammatory painkiller and a muscle relaxant that helps provide symptomatic relief from symptoms caused by menstrual pain and cramps. It is also used to treat soft tissue swellings, fever, and injuries related to fractures, tooth decay, and minor surgeries,” she says. 

Dr Aruna Kalra, Department of Obstetrics and Gynaecology, CK Birla Hospital, Gurugram, says the associated risks of rashes, fever, and other symptoms are very rare. 

“In my 25 years of practice, I have not encountered any such side effects. Though every medicine has its side effects/unpleasant symptoms, which range from nausea, diarrhoea, constipation, gastritis etc, no life-threatening side effects are mentioned. And if consumed for a short duration with a proper meal, it is better tolerated,” she says. 

However, she’d like to research more about it; and, in the meanwhile, she would reduce prescribing the usage and try alternative medicines. 

Dr Chandrashekar says the side effects associated with the drug warrant against regular usage for menstrual cramps. 

“Occasional intake is still safe. In patients with kidney function impairment or kidney failure, the drug must be completely avoided,” she advises.

Dr Shivani Sachdev Gour, Director of SCI Healthcare, gynaecologist, and IVF expert, says it’s shocking to know that Meftal Spas has been found to be associated with such adverse reactions.

“We will surely have more clarity on the same from the Indian Pharmacopeia Commission regarding its use. Meanwhile, in view of safety concerns, we advise patients to avoid any over-the-counter painkillers, especially Meftal Spas. It should be used strictly under the supervision of the doctor, and any adverse side effects should be reported at the earliest,” she says.