Event of Visual Impairment and Loss with Off-Label Administration of AVASTIN Injection

In the middle of September 2023, frequent cases of vision loss and impairment of diabetic patients were reported in Lahore-Pakistan. Many diabetic patients lost their precious vision.¹ with the progression of the cases, the DRAP (Drug Regulatory Authority of Pakistan) found that patients were administered an Avastin 100mg/4ml injection (an angiogenic drug used for treating colorectal and other metastatic carcinomas)². Up to 65 cases were reported in the province of Punjab.^1,7
According to the data, Avastin is a registered drug by Roche Pharma Pakistan, which offers it in dosages of 400 mg/16 ml and 100 mg/4 ml. It is advised and suggested for the treatment of colorectal and other metastatic carcinomas, according to the FDA and DRAP. ^{3, 5, 6} But as an off-label indication, it can be used in the diabetic retinopathy condition, in which there is blockage in the blood vessels of the eye that causes blurred vision. This incident happens when an unregistered pharma company by the name of Genius dispenses, dilutes, and repacks Avastin in an unhygienic condition and sells it in a 1.25 mg/0.05 mL dose. Therefore, it’s not safe and leads to vision loss in diabetic patients. ⁴
The regulatory bodies rapidly raided the premises of its local marketing company in Lahore, which was involved in the repackaging and dispensing as well as the sale of the Avastin injection.
The company has been sealed, and legal procedures have been started again for the stakeholders of the company. On the other hand, a registered drug from Avastin’s sample was taken and sent to the testing lab for further evaluation to analyze the safety and efficacy of the drug. Roche Pharma recalls the following batches from the market: H0352B11, B7266B20, and B7266B07. The company stops the distribution and administration of the drug throughout the country till a clear report of this incident.⁴
It's a serious issue that is resigning in Pakistan that multiple unregistered pharma companies and a lack of health care providers cause these types of major events and that multiple patients have lost their vision. It’s a public service message to all the health care providers, like ophthalmologists, diabetologists, and general physicians, to avoid the use of local and unregistered brands, as it all costs the patient’s life.
In our opinion, it is 2% of the population, but for the individual, it is his 100% loss. Make sure to notice, monitor, and report these types of side effects as soon as possible, and develop a center for pharmacovigilance in all the update on drug’s knowledge, side effects, and use, avoidance of off-label use of the product should be discouraged.