The circular is titled “Indiscriminate use of painkillers (NSAIDs), antibiotics and associated risk of Chronic Kidney Disease (CKD).”Which medicines are the CDSCO concerned about?
While both categories of medicines can cause adverse effects when used inappropriately, their relationship with kidney disease is not the same.
Dr Banerjee says the relationship between antibiotics, NSAIDs, and CKD is not the same.
AdvertisementAdvertisementWith antibiotics, their inappropriate use can cause antibiotic resistance, adverse effects, and unnecessary drug exposure, with selected antibiotics capable of causing drug-related kidney injury.
For painkillers, repeated or prolonged NSAID use – particularly in people with kidney disease, dehydration or other risk factors – requires caution.
The Central Drugs Standard Control Organisation has issued an advisory against the indiscriminate use of painkillers and antibiotics. It has warned that prolonged use can lead to kidney-related disease. The bottom line: Do not self-medicate
The Central Drugs Standard Control Organisation (CDSCO) has warned against the indiscriminate use of painkillers, particularly non-steroidal anti-inflammatory drugs (NSAIDs), and antibiotics, citing the risks associated with their inappropriate use.
In a circular published on its website on September 22, the drug regulator advised healthcare professionals, pharmacies, retailers, distributors, and hospitals to ensure that these medicines are used appropriately and that prescription requirements are followed. The circular is titled “Indiscriminate use of painkillers (NSAIDs), antibiotics and associated risk of Chronic Kidney Disease (CKD).”
Which medicines are the CDSCO concerned about?
The warning particularly concerns non-steroidal anti-inflammatory drugs (NSAIDs), a commonly used group of painkillers.
NSAIDs reduce pain, inflammation, and fever. They include medicines from a widely used class of analgesics, but they are not risk-free, particularly when taken inappropriately or for prolonged periods.
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The circular also covers antibiotics, which are used to treat bacterial infections.
However, the advisory makes an important distinction. While both categories of medicines can cause adverse effects when used inappropriately, their relationship with kidney disease is not the same.
The kidneys receive a large amount of blood and filter waste while maintaining the body's fluid and electrolyte balance. Certain NSAIDs can interfere with mechanisms that help maintain blood flow to the kidneys. Representational image/Pixabay
Why is CDSCO warning against painkillers?
The regulator advises using painkillers in the lowest effective dose for the shortest appropriate duration, particularly in patients at higher risk of kidney impairment.
The kidneys receive a large amount of blood and filter waste while maintaining the body's fluid and electrolyte balance. Certain NSAIDs can interfere with mechanisms that help maintain blood flow to the kidneys. This can become particularly important in people who already have impaired kidney function or other risk factors.
The CDSCO has specifically advised people with pre-existing kidney disease or other risk factors for renal impairment to inform their healthcare professional before using NSAIDs. It has also asked doctors to take particular precautions when prescribing NSAIDs to patients with kidney impairment, dehydration, cardiovascular disease, and other conditions that may increase the risks associated with their use.
“These medicines can affect kidney function because they inhibit prostaglandin production, substances that help maintain blood flow to the kidneys. In susceptible people, this can contribute to acute kidney injury (AKI), water and sodium retention, increased blood pressure, and worsening of existing kidney disease,” warns Dr Amitav Banerjee, professor emeritus at Dr DY Patil Medical College, Pune.
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According to Dr Banerjee, the painkiller use in large doses and for a long time can cause a reversible fall in glomerular filtration rate (GFR), the volume of fluid filtered from the kidney’s tiny blood filters, called glomeruli, per minute.
What is the advisory on the use of antibiotics?
Antibiotics are a different story.
This is where the CDSCO circular requires some context: while NSAID use can cause kidney damage, inappropriate use of antibiotics is harmful to the kidneys.
The regulator's message on antibiotics is even more explicit: Do not self-medicate.
Antibiotics work against bacterial infections and do not treat most viral infections. Yet antibiotics are sometimes taken for conditions such as common viral illnesses simply because a person has fever, cough, or other symptoms.
The CDSCO has advised against using antibiotics when they are not clinically indicated. It has also asked people not to share antibiotics with others or use leftover medicines from a previous prescription.
Another concern is antimicrobial resistance, where bacteria become resistant to the medicines used to treat them. The World Health Organization (WHO) says inappropriate antimicrobial use accelerates resistance, and antibiotics should not be used for viral infections such as colds and influenza.
According to Dr Banerjee, the advisory’s central message is reasonable: People should avoid indiscriminate, repeated, or prolonged antibiotic use. They should not self-medicate; antibiotic prescribing should follow antimicrobial-stewardship principles and promote the optimal selection, dosing, and duration of antimicrobial treatments to achieve the best clinical outcomes while minimising toxicity, side effects, and resistance.
“The principal population-level concern with indiscriminate antibiotic use is antimicrobial resistance, inappropriate treatment, adverse drug reactions, and unnecessary antibiotic exposure – not that routine antibiotic use itself is a major generic cause of CKD,” he said.
But that is different from saying that routine antibiotic use is itself a major generic cause of CKD.
So what exactly is the kidney risk?
Dr Banerjee says the relationship between antibiotics, NSAIDs, and CKD is not the same. “The most important conceptual weakness is putting NSAIDs and antibiotics together as associated with risk of CKD. The relationship is not equivalent.”
Banerjee points out that the renal risk associated with NSAIDs has a well-established pharmacological basis and prolonged use, mostly in susceptible people or those with already existing kidney disease, can cause progression of kidney disease.
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With antibiotics, their inappropriate use can cause antibiotic resistance, adverse effects, and unnecessary drug exposure, with selected antibiotics capable of causing drug-related kidney injury.
India's drug regulator has advised pharmacies to ensure that prescription requirements are followed. File image/Reuters
Should you stop taking painkillers or antibiotics?
No. The CDSCO circular is not a warning to stop using these medicines altogether.
Both NSAIDs and antibiotics have legitimate and important medical uses. The issue is when, why, how much, and for how long they are used.
The circular asks the general public not to take NSAIDs or antibiotics indiscriminately or for prolonged periods without medical advice. It also reminds stakeholders that many NSAIDs are covered under Schedule H. In contrast, most antibiotics are covered under Schedule H1 of the Drugs Rules, 1945, meaning their sale is subject to prescription requirements.
For painkillers, repeated or prolonged NSAID use – particularly in people with kidney disease, dehydration or other risk factors – requires caution. For antibiotics, the key message is not to self-medicate. Use antibiotics only when a bacterial infection warrants them and follow the prescription.
And if symptoms persist or repeatedly return, taking another painkiller or antibiotic without finding the underlying cause may not be the answer.
