In Delhi, on April 2, 2017, around 20 eye patients had to be rushed to AIIMS from the GTB Hospital as they complained of breathlessness, blurred vision, redness, etc after being injected with allegedly Avastin.
Raising the matter for the second time in last four months, the National Human Rights Commission (NHRC) has now asked the Delhi government to submit a report by August 5 on the April incident at Guru Teg Bahadur (GTB) Hospital, where around 20 patients suffered from severe eye problems after they were administered contaminated injections of a drug called Avastin.
In Delhi, on April 2, 2017, around 20 eye patients had to be rushed to AIIMS from the GTB Hospital as they complained of breathlessness, blurred vision, redness, etc after being injected with allegedly Avastin. On April 7, 2017, the National Human Rights Commission (NHRC) took “suo motu cognizance” of the media reports on the incident and issued a notice to Delhi government’s chief secretary M M Kutty, asking him to submit a “detailed report” on this matter within four weeks.
After not having received any report in the stipulated time period from the Delhi government, on July 5, 2017, the NHRC sent another reminder to Kutty: “The requisite report has not been received so far. It is requested that the report called for be sent to the Commission by August 5, 2017.” Kutty and GTB hospital did not respond to the queries sent by The Indian Express.
Avastin is a cancer drug of the multinational pharmaceutical company Roche. Ophthalmologists across the world have been using this cancer drug to treat eye diseases such as age-related macular degeneration (AMD) because it has been extremely cheap compared to other eye medicine called ‘Lucentis’ that is available in the market. Further, a 2012 clinical trials study titled “Comparison of AMD Treatments Trials” showed that there was no significant difference between Avastin and Lucentis when it came to efficiency or adverse effects on patients. Lucentis is a drug of Novartis and it has been approved worldwide specifically to treat AMD.
On May 25, Roche India told The Indian Express the reasons for contamination: “The product formulation of Avastin is only approved for single use in specific cancer indications. It is not a multi-dose preparation because it does not contain preservatives and is not designed to be injected in the eye. When a physician makes a choice to use it off-label in the eye, the original product is typically partitioned/aliquoted in a hospital or pharmacy, potentially for use in multiple patients. This process bears the risk of bacterial contamination and has already led to serious bacterial infections of the eye in other countries around the world.”
On January 13, 2016, 15 patients at CH Nagri Eye Hospital in Ahmedabad complained “loss of vision” after Avastin was injected in their eyes. On September 1, 2011, five patients being treated for eye disease were blinded after being injected with Avastin at the Veterans Affairs medical center in Los Angeles. In February. 2016, a physician in Egypt reported health authorities about his 13 patients who were treated from a single vial of Avastin on a single day and started facing untoward occurrences later such as eye bleeding, vision loss and blindness.
“Information regarding these events has been published and the risks are also included in our prescribing information, which is inserted in each pack. We strongly recommend that Avastin should be used in line with the approved prescribing information and not for any eye indication,” Roche India added. While some countries have issued guidelines for this off-label use of Avastin, Indian health ministry as well as Indian central drug regulator have issued no such guidelines as yet.
“Avastin is an important cancer therapy and is approved for intravenous treatment of several types of advanced cancer. We would like to highlight that Avastin has not been approved for use in the eye by the US FDA (Food and Drug Administration), EMA (European Medicines Agency) or the Government of India,” Roche India added.
