The decision was made after a national review
NEW DELHI: Two widely used drugs – the antibiotic doxycycline and the drug carbimazole – will soon carry stronger safety warnings, following a national review of reports of adverse drug reactions.After examining patient-level safety data, regulators cited potential mental health symptoms associated with doxycycline and a rare but potentially life-threatening blood disorder associated with carbimazole. In separate letters issued this month, the Central Drugs Standards Control Organization (CDSCO) and the Drugs Controller General of India (DCGI) have directed all licensing authorities in states and union territories to ensure that manufacturers update prescription information and pack inserts for both medicines and report compliance.For doxycycline — which is commonly prescribed to treat respiratory infections, acne, sexually transmitted infections, urinary tract infections and several vector-borne diseases — authorities asked that specific side effects on the central nervous system be explicitly mentioned. These include insomnia, anxiety, irritability, nervousness and dizziness.The decision comes after an evaluation by the Pharmacovigilance Program in India, which reviewed reports of adverse reactions and safety data of individual cases.
This issue was considered at a Signal Review Committee meeting in March 2025, and was subsequently discussed by the Subject Expert Committee (SEC) on Antimicrobial and Antiparasitic Drugs in January 2026, which endorsed updating the official prescribing documents.While gastrointestinal discomfort and photosensitivity are already known side effects of doxycycline, the latest guidance officially adds neuropsychiatric symptoms to the safety profile.
Regulators have directed manufacturers of carbimazole — prescribed for hyperthyroidism, including Graves’ disease — to clearly warn about agranulocytosis, a rare but serious condition characterized by a severe decrease in white blood cells.Agranulocytosis can make patients susceptible to severe infections. Early warning signs include fever, sore throat and unexplained infections. The recommendation emerged from the 26th meeting of the Indication Review Committee and was subsequently reviewed by the Securities and Exchange Commission on Endocrine and Metabolic Diseases before approval for inclusion in the Prescribing Information Bulletin.Dr Romil Tiko, director of internal medicine at Max Hospital, Saket, said the move reflects the maturity of the safety system. “CDSCO’s decision on doxycycline and carbimazole reflects a proactive and responsible pharmacovigilance system. While the drugs remain safe and effective when used appropriately, clearer warnings help doctors and patients recognize rare but important side effects early. In the case of carbimazole, immediate attention to symptoms such as fever or sore throat can be life-saving.”
Such regulatory steps enhance patient safety without creating unnecessary alarm, he said.For patients, updated leaflets mean clearer information about risks. For clinicians, this advice reinforces the need to counsel patients about warning symptoms and monitor use appropriately.
