Experts warn against overuse of last-line antibiotics

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Infectious diseases experts have flagged the overuse of a potent antibiotic leading to it losing its efficacy, and drug resistance. The Drugs Controller General of India has been urged to lay down strict pathways for these newer antibiotics, so that they are not misused by practitioners.

Abdul Ghafur, infectious diseases specialist, and founder of the AMR Declaration Trust, has written to Rajeev Singh Raghuvanshi, DCGI, about ceftazidime-avibactam. “One of the most potent antibiotics currently available in our armamentarium is rapidly losing its efficacy due to extensive, irrational, and uncontrolled use.”

The drug which was initially registered with the U.S. FDA in 2015 and approved in India three years later is a last-line antibiotic. It is to be used as targeted therapy for certain carbapenem-resistant gram-negative infections and not prescribed as a broad spectrum antibiotic.

Dr. Ghafur however claims it is already being misused in the community. “To overcome this resistance, aztreonam is often added to ceftazidime-avibactam, unfortunately, resistance has now emerged even to this combination, due to irrational use.”

The problem, he explains, is that while the DCGI has licenced the drug, it has only provided indications for use. There are no clear-cut pathways laid out, and nothing to deter mis-prescriptions.

This trend could erode the huge gains secured in India primarily with the ban on use of colistin as a growth promotion drug amongst poultry, in recent times. This ‘bold and meaningful action’ from the government resulted in a significant drop in prevalence of colistin-resistant bacteria in hospitals in India, he adds.

Rational use

There are two new very powerful antibiotics that are about to enter the Indian market, Cefierocol and Cefepime-zidebactam. Dr. Ghafur urges the DCGI to kick in with antibiotics stewardship: “We need these drugs in India. However, their use must be restricted strictly to infections where no other effective alternatives exist. Education alone is not enough; we need a clear regulatory pathway to ensure the rational use of these molecules from the moment they are licensed.”

“If we do not act now, we risk losing the few therapeutic options left. Antimicrobial resistance (AMR)is already a serious crisis in our country. Without urgent and strong action, it may escalate to an unmanageable level. We cannot change the past — but we still have time to act for the immediate future,” he says.