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CDSCO tightens fluoroquinolone labelling norms to add warnings about mental health problems, hypoglycaemia
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Arun Sreenivasan, New Delhi
October 26 , 2018
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Manufacturers of fluoroquinolones, a class of antibiotics commonly used to treat respiratory and urinary tract infections, now have to strengthen warnings on drug labels about potential side effects such as mental health problems and serious blood sugar disturbances. The Central Drugs Standard Control Organisation (CDSCO) has made the labelling regulations for these antibiotics rigorous on the recommendation of its Antimicrobial and Antiviral Subject Expert Committee.
The national regulator’s move comes close on the heels of a similar action taken by the US Food and Drug Administration (FDA). Some widely used medications that come under this category include ciprofloxacin, gemifloxacin, levofloxacin, moxifloxacin, norfioxacin and ofloxacin.
The Drugs Controller General of India Dr Eswara Reddy has directed all state drug controllers to make sure that the new labelling norms are immediately implemented on labels and in promotional literature of all fluroquinolone antibiotics.
As per the order, a copy of which has been reviewed by Pharmabiz, the label of the product should have a cautionary note that the “drug may cause low blood sugar and mental health-related side effects”.
Moreover, the package insert and promotional literature should mention the details as follows: "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”.
The mental health side effects to be added to or updated across all the fluoroquinolones are disturbances in attention, disorientation, agitation, nervousness, memory impairment and delirium.
The FDA first added a boxed warning to fluoroquinolones in July 2008 for the increased risk of tendinitis and tendon rupture. However, a recent FDA review found instances of hypoglycemic coma among users. As a result, in the US, the Blood Glucose Disturbances subsection of the labelling for all systemic fluoroquinolones is required to explicitly reflect the potential risk of hypoglycemic coma.
The FDA announced labelling changes to make warnings more consistent across labelling. Since the antibiotic class is crucial for the treatment of serious bacterial infections, the FDA wants to keep this available as a therapeutic option in cases where the benefits outweigh the risks. “The FDA remains committed to keeping the risk information about these products current and comprehensive to ensure that health care providers and patients consider the risks and benefits of fluoroquinolones and make an informed decision about their use,” its statement reads. The labelling changes are based on a comprehensive review of the adverse event reports published in medical literature.
FDA-approved fluoroquinolones include levofloxacin (Levaquin), ciprofloxacin (Cipro), ciprofloxacin extended-release tablets, moxifloxacin (Avelox), ofloxacin, gemifloxacin (Factive) and delafloxacin (Baxdela). There are more than 60 generic versions.
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