The Central Drugs Standard Control Organisation (CDSCO), India’s top drug regulator, is planning to change the labelling norms for fluoroquinolone class of antibiotics. The intended change is to bolster the warnings about the risks of mental health side-effects and serious blood sugar fluctuations.
The proposed regulation is close in line with a similar action taken by the US Food and Drug Administration.The US drug regulator announced safety labelling changes to make warnings more consistent across the labelling for all fluoroquinolones taken by mouth or given by injection.
India’s Minister of State for Health and Family Welfare, Anupriya Patel stated in Parliament that “in view of the action of US FDA on labelling changes of fluoroquinolones, the Drug Controller General of India is examining the issue in consultation with subject expert committee of CDSCO”.
The list of fluoroquinolones approved by US FDA include levofloxacin, ciprofloxacin (Cipro), ciprofloxacin extended-release tablets, moxifloxacin ofloxacin, gemifloxacin and delafloxacin.
The US agency went on to insist labelling changes following a recent review that found instances of hypoglycemic coma where users of fluoroquinolones experienced hypoglycemia.
The US FDA first added a Boxed Warning to fluoroquinolones in July 2008 for the increased risk of tendinitis and tendon rupture.