Back in 2023, the United States Food and Drug Administration (US FDA) issued a high number of black box warnings, primarily due to emerging evidence from post-marketing studies that identified serious, life-threatening risks. Medicines listed under Schedules G, H, H1 and X carry boxed warnings under Indian regulations, according to a top official with the Kerala State Drug Control Department.
Considering the health issues that certain medicines can cause, doctors have also been directed to prescribe such drugs cautiously and only when necessary. However, over-the-counter sale of these medicines poses a threat even as the Central Drugs Standard Control Organisation (CDSCO) has mandated strict regulations on drug sales to prevent misuse and ensure safety.
“The labelling, under the Drugs and Cosmetics Rules, 1945, aims to indicate risks and control the sale of medicines. These medicines can only be sold with a prescription or under the supervision of a doctor. Earlier, there was rampant use of these medicines. We need to control the unnecessary sale and consumption of medicines that have serious side effects, including addiction potential, hypersensitivity reactions, and other complications,” said an official with the Kerala Drugs Control department, adding that monitoring and strict implementation of rules play a key role in curbing misuse.
Explaining the significance of black box warnings, Dr Rajeev Jayadevan, convenor of IMA Research Cell, said such warnings are issued when serious side effects become evident.
“A rare but serious side effect may become apparent only after a drug is used by millions of people. The risk might not be evident in early phases or during clinical trials because sufficient numbers of people have not used it yet. Another reason is the growing use of newer treatments for conditions ranging from cancer, arthritis and colitis to cardiovascular diseases. Many of these are biologicals, and some carry serious side effects alongside clinical benefits. Such medications must therefore be used with great caution and only for the right indications, after weighing risks and benefits. When serious new side effects are identified, black box warnings may be issued,” he said.
The official added that, at a time when antimicrobial resistance (AMR) poses a major threat, the sale of antibiotics must also be restricted. “Doctors are directed and trained to prescribe antibiotics only when required. Indiscriminate consumption of antibiotics and their entry into the environment through improper disposal contribute to AMR. We need to be more cautious about antibiotic use,” he said.
For the public, a boxed warning does not mean a drug should never be used — only that it must be used judiciously for the right patient. “The choice of medicines depends on the diseases doctors treat. They are aware of the pros and cons through training, academic conferences such as continuing medical education (CME) programmes, and updated medical literature. Modern electronic medical record (EMR) systems in hospitals also provide automated alerts while prescribing,” Dr Rajeev added.