Labels on fluoroquinolones should alert on mental health risk: DCGI

December 13, 2018 0 By FM

India’s drug regulator has directed safety labelling changes for antibiotics belonging to the class of fluoroquinolones to strengthen warnings about risks of mental health side effects and serious blood sugar disturbances.
The Drugs Controller General of India (DCGI) made the labelling regulations for these antibiotics stricter after the recommendation of its Antimicrobial and Antiviral Subject Expert Committee.
Through an order, the DCGI has directed all state drug controllers to ensure immediate implementation of the new labelling norms on all fluoroquinolone antibiotics such as levofloxacin, ciprofloxacin, moxifloxacin, ofloxacin and gemifloxacin.
Apart from the cautionary note on the label saying the drug “may cause low blood sugar and mental health-related side effects”, the package insert and promotional literature should mention: “The drug may cause low blood sugar and mental health-related side effects. Low blood-sugar levels, also called hypoglycemia, can lead to coma. The mental health side effects are more prominent and more consistent across the systemic fluoroquinolone drug class”.
In July, USFDA mandated a new class-wide labelling change requiring that mental health side effects be listed separately from other central nervous system side effects across fluoroquinolone antibiotics.
Mental health side effects to be included in the labeling across all fluoroquinolones are disturbances in attention, disorientation, agitation, nervousness, memory impairment and delirium.
Additionally, the FDA required new labelling for all systemic fluoroquinolones to explicitly reflect the potential risk of coma with hypoglycemia.