Patients report eye inflammation, Intas recalls its drug batch

‘UNDERTAKING DETAILED ANALYSIS’

WITH SOME patients reporting inflammation in their eyes due to Intas Pharmaceuticals’ drug Razumab, the company has advised the doctors to not use any drug of this particular batch. It has also recalled this batch from the market to undergo internal testing at its quality control (QC) lab.

“Intas is aware of few incidences of post injection inflammation reported pertaining to this specific batch, the reported incidences are well within the limits, which were managed by usual anti-inflammatory treatment. We are extremely conscious of our product quality and are undertaking a detailed analysis of the same. Since patient’s safety is paramount to us, hence till the time the analysis is completed, we have advised the doctors to avoid using the product from this specific batch,” Intas Pharmaceuticals’ spokesperson told The Indian Express.

According to an email sent by Raja Narayanan, secretary, Vitreo Retina Society – India (VRSI), to its members, the company has “advised not use Razumab injection of batch number 18020020”. The VRSI has total 750 ophthalmologists as its members spread across the country. “VRSI is gathering more facts on the situation. It is advised that all members be alert and exercise abundance of precaution with other batches of Razumab also,” Narayanan added in his email. In its preliminary report, the VRSI stated that

Intas has recalled all vials of this batch for internal testing at company’s QC lab.

This is the second time VRSI has reported the adverse reactions of Razumab. It first reported the adverse reactions in 2015, just two months after the brand was launched by Intas Pharmaceuticals. Consequently, Intas had curtailed the distribution of Razumab then. Ranibizumab is the name of the molecule; Intas Pharmaceuticals and Novartis sell them in the Indian market under the brand name Razumab and Lucentis, respectively. Lucentis is the market leader and is available for approximately Rs 75000 per 1 ml injection at a retail chemist.

In 2015, Intas became the first company globally to launch biosimilar version of Ranibizumab. According to retailers, Razumab is available at around 25 per cent lower price in the country. Meanwhile, Naryanan told The Indian Express that as a standard procedure, Intas Pharma has withdrawn this particular batch of Razumab that has caused adverse reactions in some patients.

Intas Pharmaceuticals’ spokesperson told The Indian Express: “It is a known fact that, few patients getting such intravitreal injections are likely to experience such inflammation, as also reported in published data and pack insert of innovator Ranibizumab (mentioned as 18 per cent of patients). The reported incidences are well within the limits.”

In people with a certain type of eye disease, new blood vessels grow under the retina where they leak blood and fluid. This is known as the “wet form” of macular degeneration. Ranibizumab is used to treat wet age-related macular degeneration. This molecule is also used to treat swelling in the retina caused by diabetes or by a blockage in the blood vessels.

The VRSI had issued a primary alert on March 18 after first incidents of intraocular (middle layer of the eye) inflammation were reported, after which it did a preliminary investigation. In preliminary investigation, it found that “total 11 eyes from 5 centers” have reported this inflammation.

“Batch (180200)20 was released from factory on February 28. Intas had released 824 vials of Razumab to stockists. 435 vials were purchased by various doctors/hospitals. 182 out of those 435 were used on patients. The first reports of inflammation were received on March 9. As soon as the first events were reported to Intas, the company gave two samples each for clinical testing to two VRSI members. Both reported inflammation after the first injection itself. Intas advised us to stop use of batch 20,” the preliminary report stated.

“Total 11 eyes from 5 centers out of 182 injections have officially reported inflammation. All patients were treated with topical steroids and some with oral steroids. Intas has recalled all vials of batch 20 and is undergoinginternaltestingintheirqclab. Other batches have not been reported to cause inflammation. Intas will share the QC report with VRSI in the next three days, “the preliminary report of VRSI added.

Intas Pharmaceuticals’ spokesperson told The Indian Express: “Intas markets Razumab for debilitating eye complications of diabetes like diabetic macular edema, diabetic retinopathy where no other alternatives exist. We market it as social responsibility to alleviate sufferings of such patients of our country. As a responsible organization, we continuously strive to update the medical experts on the scientific aspects of our products and expected adverse events.”