The Indian Pharmacopoeia Commission (IPC) recently released a March 2025 drug safety warning regarding adverse reactions associated with five popular drugs, namely Metronidazole, Luliconazole, Dalteparin, Gliclazide, and Tramadol. The warning is a result of reports gathered under the Pharmacovigilance Programme of India (PvPI).

Key Highlights:Adverse effects reported for more than one drug category

• Metronidazole: Employed to treat giardiasis, trichomoniasis, and amoebiasis, can lead to Acute Generalised Exanthematous Pustulosis (AGEP), an unusual, serious cutaneous reaction.

• Luliconazole: Oftentimes prescribed for fungal infections, can initiate chloasma/melasma, leading to skin pigmentation disorders.

• Dalteparin: An anticoagulant for cancer-related venous thromboembolism therapy, can induce muscle spasms.

• Gliclazide: An oral anti-diabetic, has been reported to cause erythema multiforme, a hypersensitivity dermatosis.

• Tramadol: Used to treat severe pain, can result in fixed drug eruption — persistent skin lesions.

Monitoring and reporting recommended

• Medical practitioners have been recommended to remain cautious when prescribing these drugs.

• Patients and care providers are encouraged to report any suspected side effects through the PvPI reporting avenues.

Quotes by Leaders or Officials
The IPC mentioned that the safety alert is meant to promote a culture of pharmacovigilance. They have called on healthcare professionals to report any adverse drug reactions immediately through the PvPI online portal or the ADR PvPI App.This new alert underscores the need for ongoing monitoring of drug safety, particularly for commonly used drugs. Through greater awareness and timely reporting, health care professionals can help to mitigate drug-related harm and enhance patient outcomes.