Hyderabad: Intravitreal Razumab injections of Batch N. 18020052 have been found to cause intraocular inflammation and have been recalled, according to a patient safety advisory issued by the Vitreo Retina Society of India.
In the present batch, the injection was found to have adverse effects on 11 patients where there was inflammation in the eyes and loss of vision.
The side-effects of Razumab, which is a biosimilar of ranibizumab, were recorded earlier too and ophthalmologists have been warned from time to time to use it with caution and only when other treatment options are exhausted.
The drug is used for macular degeneration of the eyes where problems in the vision are encountered for a long period of time.
Dr Rahul Sheshagiri, a senior ophthalmologist, said the injections are to be used only when there is hope that there will be restoration of some vision.
“Macular degeneration is a very slow process. But in patients with diabetes, the degeneration at an advanced age is seen faster. Yet if there is a follow up in terms of eye check up every two months and evaluation with diagnostic tests every six months it can be managed. The side effects of the injections have been reported in earlier batches too,” Dr Sheshagiri said.
Pharmacist Dr Sai Kumar Katam said, “There have been two sets of reports about Razumab as there are patients whose vision has been restored and those who suffer from inflammation and loss of vision. We now need to evaluate the patients who are suffering from inflammation after the delivery of this drug. Is there any other drug that they have been on before the use of this drug? Is there a drug to drug interaction or a food and drug interaction? If so, it needs to be evaluated.”
This drug is cheaper than the others which are available in the market for the treatment of macular degeneration. Prof. Bejon Misra, founder of Patient Safety and Access Initiative of India, explained, “The drug is affordable for the patients but is it safe? This is an important question and the drug regulating authorities must not compromise on quality and safety.”
Prof. Misra noted that this was the first complaint about Razu-mab as the pharmaco vigilance department in ophthalmology centres are reporting sporadic cases from time to time. There is a need for the company to look into the quality of the products.”
Razumab biosimilar is made by INTAS Biopharmaceutical.
