2 common antibiotics have side-effects: DCGI

New Delhi: Two commonly used antibiotics — ofloxacin and injectable cefotaxime — have been found to have side-effects that were hitherto unknown.

Ofloxacin, which is used commonly to treat bacterial infections, has been found to cause a severe skin reaction called Stevens Johnson Syndrome (SJS)/Toxic Epidermal Necrolysis (TEN) as an adverse drug reaction.

Injectable cefotaxime, another common antibiotic used for bacterial infections, especially joint infections, pneumonia and urinary tract infections, has been found to cause angioedema — swelling under the skin — as an adverse drug reaction. Dr S Eswara Reddy, the Drug Controller General (India), recently wrote to drug controllers in all states and union territories stating the same.

Sources said the DCGI letter was based on the recommendation of the National Co-ordination Centre for Pharmacovigilance Programme of India (NCC-PVPI). The latter discussed adverse drug reactions of the antibiotics in the 13th Signal Review Panel held in August last year and recommended necessary steps to incorporate SJS/TEN as an adverse drug reaction into the prescribing information leaflet of the drug ofloxacin.

According to letter written by Dr Reddy to all drug controllers, the PVPI recommendations were deliberated further in the subject expert committee in January also and the recommendations were reiterated to be incorporated in the package insert of the drug ofloxacin. The same process was followed for recommending the mentioning of angioedema as an adverse drug reaction in the package insert or promotional literature of cefotaxime, said officials.

Dr Rommel Tickko, associate director, Max Super Specialty Hospital Saket, said the new notifications were significant. “We will now have to be extra careful about skin reactions in people who are prescribed these medicines,” he said.