Drug makers to add SJS, TEN in package insert of Ciprofloxacin: CDSCO panel

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.

Stevens-Johnson syndrome/toxic epidermal necrolysis (SJS/TEN) is a life-threatening skin reaction triggered by some drugs. Stevens-Johnson syndrome and toxic epidermal necrolysis were long thought to be separate conditions, but they are now thought to be part of the same continuum. Stevens-Johnson syndrome is on the milder side of the disease spectrum, whereas toxic epidermal necrolysis is on the more serious side.

At a recent SEC meeting for antimicrobial and antivirals, the recommendation of the signal review panel, PVPI, IPC, was placed before the committee regarding the adverse reaction related to the drug Ciprofloxacin.

In view of the above, after detailed deliberation, the committee recommended,

"CDSCO may request State Drugs Controllers to direct the manufacturers of the drug to incorporate drug associated Stevens-Johnson Syndrome (SJS) / Toxic Epidermal Necrolysis (TEN) in the package insert of the drug."