In response to recent restrictions introduced by the UK Medicines and Healthcare products Regulatory Agency (MHRA) regarding fluoroquinolone antibiotics, Indian health regulators are evaluating the implications for the usage of these antibiotics within the country.
On January 22, the MHRA, which is responsible for regulating medicines and medical devices in the UK, issued a critical alert, specifying that fluoroquinolone antibiotics administered systemically (by mouth, injection, or inhalation) should only be prescribed when no other antibiotics are appropriate for use. "This means that fluoroquinolones should only be prescribed when other recommended antibiotics have failed, will not work due to resistance, or are unsafe to use in an individual patient," the MHRA site says.
Sources revealed to CNBC-TV18 that Indian regulators are now considering whether to introduce a fresh warning for fluoroquinolones in line with the UK's guidelines. They said India is considering adding “should only be prescribed when other recommended antibiotics have failed” as a caution.
Fluoroquinolones, a class of antibiotics approved to treat or prevent certain bacterial infections, include well-known brands such as Ciprofloxacin (Cipro), Gemifloxacin (Factive), Levofloxacin (Levaquin), Moxifloxacin (Avelox), and Ofloxacin (Floxin).
These antibiotics are commonly prescribed to address respiratory and urinary tract infections.
Several popular brands in India are associated with fluoroquinolones, including Cipla's Norflox, Mankind Pharma's Zenflox, Cipla's Levoflox, Lupin's Percin Tablet, Glenmark's Zinox, Ipca Labs' Normax, and Sun Pharma's Zanocin.
The MHRA said it conducted a thorough review into the effectiveness of current measures to reduce the risk of potentially long-term adverse reactions to fluoroquinolone antibiotics and has sought advice from the Commission on Human Medicines (CHM).
"The review process considered available evidence, including Yellow Card reports submitted by patients and healthcare professionals, and the experiences of people affected by these side effects. The restrictions have been introduced following Yellow Card reports from patients who have experienced long-lasting or disabling reactions following the use of fluoroquinolones, in some cases prescribed for mild to moderate or self-limiting infections, or non-bacterial conditions,” the MHRA said.
The Yellow Card scheme is a system for recording adverse incidents with medicines and medical devices in the UK.
The health agency says serious adverse reactions to fluoroquinolone antibiotics include tendinitis or tendon rupture, muscle pain, muscle weakness, joint pain, joint swelling, peripheral neuropathy and central nervous system effects.
Presently, there are seven FDA-approved fluoroquinolones for systemic use available on the market, including Moxifloxacin, Ciprofloxacin, Gemifloxacin, Levofloxacin, Moxifloxacin, and Ofloxacin.
(Edited by : Amrita)
First Published: Jan 25, 2024 9:00 AM IST
