Drug regulator slaps safety alerts on antibiotics

June 11, 2019 0 By FM

Drugs Standard Control Organisation (CDSCO) has ordered drug companies manufacturing certain commonly used antibiotics to carry safety warning on the labels of these medicines.

The drug regulator wanted to ensure that this information is made available to the general public.

The decision comes after the National Co-ordination Centre of the Pharmacovigilance Programme of India (PvPI) sounded caution on commonly used antibiotics including cefotaxime, ofloxacin and cefixime.

PvPI reported the risk of developing Stevens-Johnson Syndrome and toxic epidermal necrolysis among people using the antibiotic ofloxacin. Injectable cefotaxime has been implicated for causing angioedema.

The PvPI recommended that CDSCO take necessary steps to incorporate the adverse drug reactions in the prescribing leaflet of these drugs marketed in the country, reports said.

The subject expert committee under the Drug Controller General India (DCGI) examined PvPI’s suggestions and recommended to incorporate safety cautions in its packages of all such antibiotics.