The Indian Pharmacopoeia Commission under the Union Ministry of Health and Family Welfare has sounded an alert about a painkiller commonly used for menstrual cramps, saying that it can cause an adverse reaction.
The alert pertains to mefenamic acid, which is the active pharmaceutical ingredient in the popular drug Meftal Spas. It is a non-steroidal anti-inflammatory drug that is used to relieve mild to moderate pain.
On November 30, the Pharmacovigilance Programme of India, a government body that identifies drug safety problems, reported that mefenamic acid led to instances of Drug Reaction with Eosinophilia and Systemic Symptoms, or DRESS Syndrome in an unspecified number of patients.
DRESS syndrome is a rare, severe allergic reaction with a mortality rate of about 10%. It is associated with specific medications and is characterised by fever, skin rashes and blood abnormalities.
“Healthcare professionals, patients and consumers are advised to closely monitor the possibility of the above ADR (adverse drug reactions) associated with the use of the above suspected drug,” the alert by the Indian Pharmacopoeia Commission said.
Gynaecologist Suchitra Pandit said that the possibility of an adverse drug reaction is rare. “Mefenamic acid can lead to unusual reactions, very rarely it is life-threatening,” she told Scroll. “I have never seen such an adverse reaction in my career.”
Pandit said that such painkillers are known to have certain side effects based on a person’s immunogenicity, or ability to provoke an immune response to a foreign substance. “IPC [Indian Pharmacopoeia Commission] has issued a warning so that doctors can be careful and note if their patients have any side effects,” she said.