Fixed Drug Eruption in the package insert of Doxycycline to be added

Doxycycline is popularly used to treat many different bacterial infections, such as acne, urinary tract infections, intestinal infections, respiratory infections, eye infections etc.

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.

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Drug-makers to add Fixed Drug Eruption (FDE) in the package insert of Doxycycline : CDSCO Panel