Stronger warning label on popular antibiotic used to treat range of bacterial infections
The US Food and Drug Administration (USFDA) is strengthening warnings about the risk of side effects such as mental health issues and serious blood sugar disturbance associated with the fluoroquinolones class of antibiotics that are commonly used to treat illnesses such as respiratory and urinary tract infections.
This comes in the wake of findings indicating that this class of antibiotics can cause mental health problems and serious blood sugar disturbances, including hypoglycaemic coma in people with diabetes. Moreover, fluoroquinolones are most widely used in India, 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%, India reported a 103% increase, according to a study at Princeton University published in March this year.
Dr KK Aggarwal, president, HCFI, said, “Antibiotics are only effective against bacterial infections. Several studies have corroborated the adverse impact of antibiotic overuse on health. Misuse and overuse of antibiotics have made once easily treatable bacterial infections harder and often impossible to cure because bacteria evolve rapidly to evade antibiotics, leading to drug resistance. This phenomenon is on the rise not only because of their inappropriate use in human medicine but also due to practices in the agricultural industry.”
Twenty-four potent antibiotics are included in India’s Schedule H1(cannot buy over the counter) of the Drugs and Cosmetic Rules that make it mandatory for the medicines to have red-line labelling and for the pharmacist to keep a separate register with the name and address of the prescriber, patient’s name, the name of the drug and the quantity supplied.
Dr Aggarwal further added that the doctors as well as patients, should be aware of and advocate judicious use of antibiotics. Overprescription and self-prescription, both, need to be checked. One of the biggest reasons for the misuse of antibiotics is buying them over-the-counter without consultation with a doctor. Before prescribing antibiotics, always ask yourself: Is it necessary? What is the most effective antibiotic? What is the most affordable antibiotic? What is the most effective dose? What is the most effective duration for which the antibiotic should be administered?”
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.
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).
Fluoroquinolones class of antibiotics are commonly used to treat illnesses such as respiratory and urinary tract infections. This comes in the wake of findings indicating that this class of antibiotics can cause mental health problems and serious blood sugar disturbances, including hypoglycaemic coma in people with diabetes. Moreover, fluoroquinolones are most widely used in India, where hundreds of generic versions of the drugs are available.