The Post Graduate Institute of Medical Education and Research (PGIMER) filed a complaint with the Drug Controller General of India (DCGI) on Saturday, after 27 of 30 patients injected with Avastin injection developed infection at its Advanced Eye Centre (AEC).
The complaint includes a report prepared by Dr AK Jain, acting head, ophthalmology department; request for purchase of Avastin drug; and the cash memo showing that the drug was bought from a local chemist, Kumar and Company.
“All facts available with us are forwarded, with the request that it should take action against the guilty,” said a senior officer.
Since 2007, the PGIMER is buying Avastin (popular brand name for Bevacizumab) from the manufacturer (Swiss firm Roche). This was the first time (in nine years) that, due the delay in supply from Roche, the purchase committee bought the drug from a local chemist.
“In July, we bought four vials of Avastin drug from Kumar and Company. Two were of batch number B7034B03 and two others of batch number B7034B02. When the doctors used first vial of the second batch, it led to infection,” said a PGI’s purchase committee member.
Dr Jain’s report highlights what happened, what precautionary steps were taken, and the patients’ condition.
On July 12, total 30 people were injected with Avastin drug at the AEC. Next day, three complained of redness, watering, and pain in the eyes. After the doctors called others, 27 reported with severe eye infection.
The report states that the culture from Avastin Bottle Batch number B7034B02 has grown organism stenotrophomonas maltofilia, which has led to the infection. The doctor has pointed that at the AEC, ophthalmologists are using cancer drug Avastin since 2007, and nearly 32,000 injections are administered without any side-effects.
“The report mentions that sporadic incidents of inflammation were reported in the past from all over the world, but the usage should not be stopped. Patients, in need of anti-VEGF drug (Avastin), will turn blind as alternate drug Lucentis costs `23,000 per injection,” said a member of PGI administration.
Vinod Singla, owner, Kumar and Company, said, “When you puncture a vial with more than 20 injections, there would definitely be a chance of infection. I am a chemist, who sells drugs to save patients, not to harm them.”
Condition of 27 patients
“All of them are improving. They are given intravenous antibiotics for five days, so we’ll discharge them after the complete the treatment,” said Dr M R Dogra, AEC professor.
“We have operated upon 19 patients. The risk of them losing vision is unlikely. Usually, they do not improve like this, and are able to see their retina.”
Are you planning to stop the use of Avastin? “This is a wonder drug for poor patients. You look at the profile of these 27 patients. Most of them can’t afford expensive drugs. If we stop the use of Avastin, the situation will become more serious than this,” said Dr M R Dogra.
Two incidents happened at GMCH-32
“In 2014 and 2015, two incidents were reported where Avastin drug caused infection in the eyes of five to seven patients each time, but their vision was restored. Later, the ophthalmology department stopped the use of drug for eye treatment,” said Dr Sunanand Sood, head, ophthalmology, GMCH-32.
When a physician makes a choice to use it off-label in the eye, the original product is typically partitioned in a hospital or pharmacy, potentially for use in multiple patients. The process bears the risk of bacterial contamination, and has led to serious bacterial infections of the eye in other countries. Information regarding these events is 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.