Commonly used painkiller Mefenamic Acid, popularly sold under the brand name Meftal Spas, will soon add skin reaction called ‘fixed drug eruption’ to its list of possible side effects, India’s drug regulatory agency has decided.
Mefenamic Acid, which is sold under several other brand names such as Mefanorm, Mefkind and Mefast, is used for pain relief in conditions such as menstrual pain, headache, muscle, joint or dental pain.
The agency has also decided to add a new-found side effect of ‘urinary retention’ to another popular painkiller, Tramadol, sold under brand names such as Tramazac and Domadol. It is an opioid analgesic (pain reliever), which works by blocking transmission of pain signals to the brain to lower pain perception.
Several studies across the world have triggered the deliberations around these two possible side effects. While fixed drug eruption (FDE) is a pattern of a drug-induced skin reaction which is characterised by formation of blisters or ulcers in some cases, urinary retention is a condition in which one cannot empty all the urine from the bladder.
The matter to consider these side effects was sent by the Pharmacovigilance Program of India (PvPI) — which monitors the side effects of medicines on a continuous basis — to drug regulator Central Drugs Standard Control Organisation (CDSCO).
The possible side effects were discussed by the subject expert committee, which recommended that CDSCO should request the state drug controllers to direct the manufacturers of the drug to include urinary retention as an adverse drug reaction in the corresponding package insert of the drug Tramadol and fixed drug eruption as adverse drug reaction in the corresponding package insert of Mefenamic Acid.
“Communication has been sent to the state drug regulators and soon, the latest instructions will be added to the product leaflets,” a government official told News18.com.
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