Pharma standards body Indian Pharmacopoeia Commission (IPC) has issued a drug safety alert over nimesulide, saying the pill can trigger rashes on the skin (fixed drug eruption). It asked consumers and healthcare professionals to closely monitor the use of the drug and report any adverse reaction to the National Coordination Centre-Pharmacovigilance Programme of India of the IPC.
According to the IPC, the drug is used in inflammatory conditions including joint disorders like rheumatoid arthritis, post-traumatic and post-operative painful conditions and fever, as well as in acute pain in orthopaedic, ENT and dental conditions.
Sandeep Budhiraja, group medical director at Max Healthcare, said a fixed drug eruption is a drug rash on the skin and it happens only in specific locations on the body. The only treatment for this, he says, is that “you have to remove the culprit drug”. The adverse reaction is not contagious.
“Companies manufacturing nimesulide may be asked to insert warnings in their package insert so that patients and doctors know about the adverse event,” a government official said on the condition of anonymity.
A safety alert has also been issued over cefuroxime, an antibiotic drug used for lower and upper respiratory tract infection, urinary tract infection, gynaecological infection and skin or soft tissue infection. A safety alert has also been issued for dutasteride+tamsulosin. The drug can trigger palpitation, the IPC said.The IPC has warned that beta blockers (metoprolol, propranolol and atenolol) used for various cardiac events can trigger temporary erectile dysfunction.
