New Delhi : The All India Ophthalmological Society (AIOS) on Monday appealed to people to immediately report any unusual eye symptoms, including swelling, redness, discharge and photophobia, particularly after using eye drops, amid concerns over possible adverse reactions linked to ophthalmic medicines.
According to estimates cited by eye specialists, 3 to 4 million people in India are newly reported or diagnosed with severe, vision-threatening eye diseases every year, underlining the importance of prompt treatment and vigilance over adverse reactions to medicines.
“If anybody suffers from swelling, redness, discharge after using eye drops or photophobia, they should immediately contact an eye doctor,” Dr Santosh G Honavar, General Secretary of the AIOS, told ETV Bharat.
The advisory comes weeks after Sun Pharma Distributors Ltd withdrew at least 10 eye drop products from the market following an alert issued by the AIOS. Dr Honavar said the AIOS has a strong surveillance mechanism through its network of around 26,000 active ophthalmologists. “We have 26,000 active members and they immediately report to our adverse impact committee whenever they find any such adverse event. If there is any pattern of adverse events with the same batch of drugs, we issue an alert to all our members,” he said.
Referring to the Sun Pharma issue, Dr Honavar described it as a routine safety alert and said the company had acted responsibly by withdrawing the products and examining the root cause. “The company did well and withdrew such medication. They analysed the root cause and informed us about the withdrawal as a precautionary measure,” he said. The products withdrawn included Depopred 2ML, Brinolar (BKC FREE), Brinzotim Eye Drops 5ML BKC FREE, Lotepred-5ML among others.
A Sun Pharma spokesperson said patient safety remains the company’s highest priority. “We have taken all necessary steps in the best interest of patients and in accordance with applicable regulatory requirements. Our teams are working diligently to restore the availability of these products so that patients continue to have access to these treatment options,” the spokesperson said.
The concern assumes greater significance given India’s enormous burden of blindness and visual impairment. The country’s National Programme for Control of Blindness and Visual Impairment covers cataract, refractive errors, glaucoma, diabetic retinopathy, childhood blindness and corneal disorders.
A nationally representative survey covering people aged 50 years and above found that 26.68 per cent suffered from visual impairment and 1.99 per cent were blind. Cataract accounted for 66.2 per cent of blindness, while corneal opacity, cataract surgery complications, posterior segment disorders and glaucoma were other major causes.
The National Blindness and Visual Impairment Survey conducted between 2015 and 2019 by the Dr RP Centre for Ophthalmic Sciences, AIIMS New Delhi, with support from the National Programme for Control of Blindness and Visual Impairment, surveyed more than 85,000 people aged 50 years and above across 31 districts in 24 States and Union Territories. The burden is also significant among people with diabetes. Another national study found that 21.1 per cent of adults aged 40 years and above with diabetes had vision impairment, while 2.4 per cent were blind. The result came from the SMART-India population-based cross-sectional study. It was conducted by a multicentre team of Indian and international researchers between December 20, 2018, and March 20, 2020. The study covered 42,147 Indian adults aged 40 years and above across 10 states and one Union Territory, using a complex cluster sampling design to generate nationally representative estimates.
Another senior eye care specialist (on condition of anonymity) said many of the recalled medicines are commonly prescribed for patients recovering from eye surgery or those suffering from chronic conditions such as glaucoma, eye infections, allergies and ocular inflammation.
“Interruption of treatment can have significant consequences,” the specialist said, adding that maintaining sterility in eye drop manufacturing is non-negotiable in a country where millions of patients depend on such medicines. “Even suspected contamination at a manufacturing facility can pose a serious risk to patient safety, making immediate product recalls essential,” the specialist said.
Doctors and patients, he added, should not continue using a recalled product merely to avoid disruption in treatment. “Doctors should immediately discontinue using a recalled product. Patients should also stop using it and contact their ophthalmologist promptly so that an appropriate alternative can be prescribed, ensuring continuity of care while safeguarding vision,” he said.
The AIOS highlights the need for patients to remain alert to symptoms after using eye drops and seek specialist advice without delay, especially as early intervention can prevent potentially irreversible damage to vision.
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