Regulator asks drugmakers to label Fluoroquinolone with side-effect warnings

Central drug regulator DGCI has asked all drugmakers manufacturing the 'fluoroquinolones' antibiotic to label it with a cautionary message about its side-effects of potentially causing low blood sugar and mental health related problems.

The warnings need to be carried on the package as well as promotional literature of the drug and follows safety issues reported by the US Food and Drug Administration (USFDA) for this drug.

In an order, the Drug Controller General of India (DCGI) S Eswara Reddy has directed all state drug controllers to ensure that the label of the product carries a cautionary message that "this drug may cause low blood sugar and mental health related side-effects".

 

Besides, the package-insert and promotional literature would also need to mention a warning: "The drug may cause low blood sugar and mental health related side effects. Low blood sugar levels, also called hypoglycaemia, can lead to coma. The mental health side effects are more prominent and more consistent across the systemic fluoroquinolone drug class".

Fluoroquinolones are antibiotics used to treat respiratory and urinary tract infections. These medicine include ciprofloxacin, gemifloxacin, levofloxacin, moxifloxacin, norfioxacin, ofloxacin etc, the order said.

The order dated October 23 has also suggested mentioning mental health side-effects like disturbances in attention, disorientation, agitation, nervousness, memory impairment and delirium across all the fluoroquinolones.

All state regulators have been asked to revert with their respective action taken reports at the earliest.

Reddy said the USFDA has warned that fluoroquinolone antibiotics may cause significant decreases in blood sugar and certain mental health side effects.

"In light of the safety issues reported by the USFDA, the matter was examined by the Central Drugs Standard Control Organization Company in consultation with the Subject Expert Committee (Antimicrobial and antiviral) in its meeting held on August 7," he said.