Popular antibiotic used in India for infections could be hazardous

The fluoroquinolones class of antibiotics that are commonly used to treat illnesses such as respiratory and urinary tract infections have been red flagged by the USFDA but are still available in hundreds of generic forms in India

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New Delhi: The recent findings have indicated that the fluoroquinolones class of antibiotics can cause mental health problems and serious blood sugar disturbances, including hypoglycaemic coma in people with diabetes. Therefore, the US Food and Drug Administration (USFDA) is strengthening warnings about the risk of side effects associated with these class of antibiotics that are commonly used to treat illnesses such as respiratory and urinary tract infections.

The situation poses a danger in India as the fluoroquinolones are most widely used in the country where hundreds of generic versions of the drugs are available.

The new safety warnings are for all fluoroquinolones, including those taken by mouth or injected. 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 percent, India reported a 103 percent increase, according to a study at Princeton University published in March this year.

The FDA first added a boxed warning to fluoroquinolone’s in July 2008 for increased risk of tendinitis and tendon rupture. In February 2011, the risk of worsening symptoms for those with myasthenia gravis was added to the Boxed Warning. In August 2013, the agency required updates to the labelling to describe the potential for irreversible peripheral neuropathy (serious nerve damage).

Across the fluoroquinolone antibiotic class, a range of mental health side effects are already described in the warnings and precautions section of the drug labelling, but differed by individual drug. The new class-wide labelling changes will require that the mental health side effects be listed separately from other central nervous system side effects and be consistent across the labelling of the fluoroquinolone class. The mental health side effects to be included in the labelling across all the fluoroquinolones are disturbances in attention, disorientation, agitation, nervousness, memory impairment and delirium.

Additionally, the recent FDA review found instances of hypoglycemic coma, where users of fluoroquinolones experienced hypoglycemia. As a result, the Blood Glucose Disturbances subsection of the labeling for all systemic fluoroquinolones will now be required to explicitly reflect the potential risk of coma with hypoglycemia.