Journal of Pharmacovigilance & Drug Safety

Orbituary of K.C.Singhal

2025-06-29T15:36:17+00:00

Orbituary of K.C.Singhal

Emergence of Ecopharmacovigilance and its possible implementation in Ayurveda

2025-06-29T15:32:20+00:00

Newer formulations and more compound drugs in AYUSH being manufactured and used in an ever-growing scale with various medical and non-medical conditions. The demand for more pharmaceutical products leads to destroying countless species of animals and plants, placing public at risk and disappearance of rain forests around the globe. The loss of these rainforests contributes to changes in the global climate. With growing research in the field of ecology and environment, many adverse effects of drugs on environment have come to light. Pharmacovigilance activities done to monitor any obnoxious reactions of drugs in Human and Animals. However, a branch of pharmacovigilance focuses on the environmental impact of pharmaceutical products, which originally started as â€œPharmaco Environmentologyâ€, involves monitoring, assessing, and mitigating the risks associated with the release of pharmaceuticals and by products into the environment and now known as Ecopharmacovigilance. It also covers the safe disposal of unused or expired drugs, managing waste from pharmaceutical manufacturing and understanding how pharmaceuticals and byproducts may affect ecosystems and human health. So, the environment is polluted not only by heavy metals, pesticides, emissions from gasoline engines, but also through pharmaceutical chemicals, industrial chemicals, therapeutic and non therapeutic medicines. The manufacturing plants producing the active substances might unintentionally release pharmaceuticals into the environment. It is said that drugs lead double lives! once APIs in administered medications have completed their intended purposes, they can take on renewed lives in environment. Few drugs synthesized and persist in environment even after its metabolism and excretion. These pharmaceuticals including TM enter into environment through various routes causing harmful effects.

Acute pancreatitis due to Danazol in a patient of paroxysmal nocturnal haemoglobinuria

2025-06-29T15:29:48+00:00

Background: An exhaustive list of the drugs causing the acute pancreatitis did not include danazol as one of the drugs. Moreover, the standard textbook of pharmacology did not include acute pancreatitis as one of the side effects of danazol. We report a patient of danazol induced acute pancreatitis.
Case presentation: A 41-year-old gentleman had been diagnosed with paroxysmal nocturnal haemoglobinuria (PNH). The patient had been started on Tab.Prednisolone-1mg/kg/day and Tab. Danazo l- 200mg/bd. After a month, the patient presented with acute abdomen with pain in the
epigastrium radiating to the back. Investigations confirmed acute pancreatitis and acute kidney injury.
We have diagnosed acute pancreatitis due to Danazol.The patient improved with the stoppage of danazol and support of dialysis.
Discussion: Eventhough eculizumab and ravulizumab are currently the preferred treatments for PNH, government-run facilities continue to employ steroids and danazol. Therefore, it is crucial to be aware of this side effect.
Conclusion: We reported acute pancreatitis caused by danazol in a patient of PNH. We did not attempt to re-challenge our patient with the danazol for the evident reason that the underlying PNH could become life-threatening.

When the Remedy Becomes the Rash: A Case of Fixed Drug Eruption Due to Paracetamol Use in a Leukemia Patient

2025-06-29T15:34:35+00:00

Background: A Fixed Drug Eruption (FDE) is a localized cutaneous adverse drug reaction marked by the recurrence of lesions at the same site upon re-exposure to a particular drug. While NSAIDs and antibiotics are commonly implicated, paracetamol is also known, though less frequently, to induce FDE.
Case report: A 38-year-old male with chronic myeloid leukemia (CML), well-controlled on dasatinib for the past two years, presented with recurrent fixed drug eruptions after taking paracetamol (650 mg) for fever and cold. The episode was complicated by cellulitis with blister formation on the right armâ€”a new development for the patient. The FDE lesions appeared at previously affected sites, suggesting reactivation due to paracetamol exposure
Conclusion: This case underscores the need to recognize paracetamol as a potential cause of FDE. It highlights the importance of thorough drug histories, patient education, and safe analgesic alternatives in recurrent FDE, especially in immunocompromised individuals.