Off-label use of Avastin in Pakistan: Lessons from the 2023 Punjab outbreak.

Abstract

Off-label drug use, which involves prescribing medications beyond approved indications or dosages, is common in countries like Pakistan where regulatory oversight is limited. Avastin (Bevacizumab), originally approved for cancer treatment, is widely used off-label in ophthalmology to treat conditions such as diabetic retinopathy due to its anti-VEGF effects and lower cost compared to approved alternatives like Ranibizumab. However, its intravitreal use requires strict sterility and compounding standards. In 2023, an outbreak of vision loss occurred in Punjab, Pakistan, affecting 66 patients following intravitreal Avastin injections. Investigations linked the incident to contamination caused by improper repackaging and handling outside sterile conditions, revealing significant gaps in regulatory enforcement and clinical safety protocols. This outbreak highlights the urgent need for clear national guidelines, strict compounding practices, and informed consent to ensure patient safety. Although Avastin remains valuable for ophthalmic use, its safe administration depends on rigorous quality control. Lessons from this incident should guide efforts to improve drug safety and prevent future adverse events.