Drug-makers to add Fixed Drug Eruption (FDE) in the package insert of Doxycycline : 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 Doxycycline to include drug associated Fixed Drug Eruption (FDE) in the package insert of the drug.

Fixed drug eruption (FDE) is a well-defined, circular, hyperpigmented plaque that recurs as one or a few lesions always in fixed locations upon ingestion of a drug. FDE commonly occurs on the genitals, lips, trunk, and hands.

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.

Doxycycline is a tetracycline antibiotic used to treat a wide variety of bacterial infections. Tetracyclines such as doxycycline are thought to inhibit translation by binding to the 16S rRNA portion of the ribosome , preventing binding of tRNA to the RNA-30S bacterial ribosomal subunit, which is necessary for the delivery of amino acids for protein synthesis. As a result of the above actions, the initiation of protein synthesis by polyribosome formation is blocked. This stops the replication of bacteria and produces a bacteriostatic effect.

A few  brands of Doxycycline include Pfizer's Vibazime DT, Dr. Reddy's Doxt-100 Tab, Aristo Pharma's Lenteclin-100mg Cap, etc.

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 tetracycline antibiotic, Doxycycline.

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 Fixed Drug Eruption (FDE) in the package insert of the drug."