Stronger warnings for popular antibiotics

The US Food and Drug Administration (FDA) has strengthened warnings for the fluoroquinolone class of antibiotics after they were found to cause mental health problems and serious blood sugar disturbances, including hypoglycaemic coma in people with diabetes.

Fluoroquinolones include ciprofloxacin, levofloxacin, moxifloxacin , ofloxacin, gemifloxacin and delafloxacin, which are used to treat common bacterial infections, including bacterial pneumonia. They are among the most widely used antibiotics in India, where hundreds of generic versions of the drugs are available.

India is the world’s largest consumer of antibiotics, with use more than doubling between 2000 and 2015. Against a global antibiotic increase of 65%, India reported a 103% increase, according to a study at Princeton University published in March this year.

The mental health side effects include disturbances in attention, disorientation, agitation, nervousness, memory impairment and delirium.

The new safety warnings are for all fluoroquinolones, including those taken by mouth or injected.

The labelling upgrade comes after a comprehensive review of the FDA’s adverse event reports and case reports .

The warnings are particularly of concern for India, where most prescription medicines are available over the counter at neighbourhood chemists, leading to overuse and misuse.

“Along with incentives driven drug promotion, a lack of control over fake drugs, unqualified ‘doctors’, near zero reporting of side effects to regulatory authorities and the all pervasive habit of selfprescription, is damaging the health of millions,” said Dr Chandra M. Gulhati, editor of the journal, Monthly Index of Medical Specialities.

At high risk are India’s 70 million diabetics, 47.3% of whom are undiagnosed, according to Indian Council of Medical Research.

“Fluoroquinolones could cause major fluctuations in blood sugar and can lead to hypoglycaemia, including hypoglycaemic coma. These drugs join long list of drugs which could affect blood sugar levels,” said Dr Anoop Misra, chairman, Fortis C-DOC Centre for diabetes, metabolic diseases and endocrinology.

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