Govt alert: common antibiotic treatment may be ‘life threatening'
New Delhi: The Indian Pharmacopoeia Commission (IPC), a body under the health ministry, has found a commonly used antibiotic combination—sulfamethoxazole and trimethoprim—to have shown serious adverse reactions.
This fixed dose combination drug is a popular antimicrobial medication used for the treatment of a wide range of bacterial infections such as pneumonia, bronchitis, skin infection, granuloma, urinary tract infection etc.
The commission noted that the drug is showing serious adverse reaction in the form of leukopenia, a life-threatening condition which lowers the white blood cell count.
'The analysis of Adverse Drug Reactions (ADRs) from the Pharmacovigilance Programme of India (PvPI) database revealed that suspected drug–Sulfamethoxazole + Trimethoprim–used for indication(s) like Urinary Tract infection; Respiratory-tract infection including Bronchitis, Pneumonia, infections in Cystic Fibrosis, Melioidosis, Listeriosis, Brucellosis, Granuloma Inguinale, Otitis Media, Skin infection, Pneumocystis Carinii Pneumonia— is showing adverse drug reaction called Leukopenia,' IPC in a drug alert for the month of May, seen by Mint.
IPC asked healthcare professionals, patients and consumers to closely monitor for any adverse reaction with the drug and report to the authorities if such a reaction occurs.
Medical experts said that doctors should be cautious when prescribing this combination, especially for vulnerable patients, and regular blood tests can help catch any issues early.
'Trimethoprim-sulfamethoxazole has been used for years to treat a range of common bacterial infections because it's effective and widely available. But the recent alert from the Indian Pharmacopoeia Commission about its link to leukopenia—a drop in white blood cells—is an important reminder that even well-known medicines can have serious side effects. A low white cell count can make it harder for the body to fight infections, especially in older adults or people with weaker immune systems,' said Dr R.R. Dutta, HOD, Internal Medicine, Paras Health Gurugram.
The IPC monitors adverse drug reactions among the Indian population and recommends the Central Drugs Standard Control Organization (CDSCO) to take suitable regulatory decisions for safe use of medicines.
Earlier, Mint reported that the Drugs Controller General of India has directed states/UTs to keep a close surveillance on the sale of unapproved antibiotic combinations and ensure that these cocktail drugs do not find their way to the market. The plan is to stop the misue of antibiotics.
Last year, the IPC issued 10 drug safety alerts.
Antimicrobial resistance (AMR), often due to overuse or wrong use of drugs, has emerged as a serious and growing threat to public health across the world, with around 600,000 lives being lost in India each year due to such AMR infections, as per the data available with the ministry of chemical and fertilizer.
Queries sent to the health ministry spokesperson remained unanswered.
According to Crisil market intelligence and analytics, the market size of the anti-infective segment in India stood at about ₹ 251.3 billion for FY24. These include antibiotics, antivirals, and antifungals.
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