Drug makers to add SJS, TEN in package insert of Ciprofloxacin: CDSCO panel
New Delhi: The Subject Expert Committee (SEC) functional under the Central Drugs Standard Control Organization (CDSCO) has recommended that CDSCO may request State Drugs Controllers to direct the manufacturers of Ciprofloxacin to incorporate drug associated Stevens-Johnson Syndrome (SJS) / Toxic Epidermal Necrolysis (TEN) in the package insert of the drug.
This came in line with the recommendation of the signal review panel, Pharmacovigilance Programme of India (PvPI), and the Indian Pharmacopoeia Commission (IPC), which was placed before the committee.
Ciprofloxacin is a second generation fluoroquinolone antibiotic that is widely used in the therapy of mild-to-moderate urinary and respiratory tract infections caused by susceptible organisms. Ciprofloxacin has been linked to rare but convincing instances of liver injury that can be severe and even fatal.
Ciprofloxacin binds to and inhibits bacterial DNA gyrase, an enzyme essential for DNA replication. This agent is more active against Gram-negative bacteria than Gram-positive bacteria.
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