‘Undertaking detailed analysis’: Patients report eye inflammation, Intas recalls its drug batch

Representational image. Representational image.

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 Meanwhile, Naryanan told The Indian Express that as a standard procedure, Intas Pharma has withdrawn this particular batch of Razumab that has caused adverse reactions in some patients.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 undergoing internal testing in their QC lab. 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.”

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Source: http://indianexpress.com/article/business/companies/undertaking-detailed-analysis-patients-report-eye-inflammation-intas-recalls-its-drug-batch-4596914/

Ford recalls 570,000 vehicles for fire risk, door latch trouble

Ford is recalling more than 570,000 vehicles in North America and Europe to fix separate problems that can cause engine fires and doors to fly open unexpectedly. The recalls will hit the company’s bottom line in the first quarter of this year. Ford said in a today’s filing with securities regulators that the recalls will cut pretax earnings by USD 295 million. The engine fire recall covers over 360,000 vehicles in North America and Europe.

In North America it includes Escape SUVs from the 2014 model year, plus the 2014 and 2015 compact Fiesta ST, the 2013 and 2014 Fusion midsize car and the 2013 through 2015 Transit Connect small van. In Europe, the recall covers the 2010 through 2015 C-Max hybrid and Focus small car, and the 2013 through 2015 Transit Connect van. All the vehicles have 1.6-Liter four-cylinder turbocharged engines.

A lack of coolant circulation could cause the engine to overheat, causing a crack in the cylinder head, according to Ford. If that happens, pressurized oil can leak through the crack, and if it hits a hot surface, could cause and engine fire. The company says it has 29 reports of fires in the US and Canada, but no injuries. Owners can continue to drive the vehicles safely and park them in garages or other structures, spokeswoman Elizabeth Weigandt said.

The company will mail customers instructions from the owner’s manual on how to check and refill coolant. Dealers also will check coolant levels for owners. If vehicles leak coolant or overheat, they should be taken to a dealer, Weigandt said. If parts are available, dealers will install a coolant level sensor and a warning light on the dashboard telling owners if the coolant level is low, Weigandt said. She did not know if the company will fix coolant leaks, but said she would check.

The company also is adding 211,000 vehicles to a 2015 recall to replace faulty door latches. That recall covers the 2014 Fiesta and the 2013 and 2014 Fusion and Lincoln MKZ. The expansion brings the total from the 2015 recall to nearly 757,000. Door latches have been a major problem for Ford vehicles during the past three years, resulting in investigations by the National Highway Traffic Safety Administration and recalls of over 3 million vehicles.

The company recalled more than 2.3 million vehicles last fall because their door latches weren’t working properly. That recall included the 2012-2015 Ford Focus and the 2013-2015 Ford Escape and C-Max. In May 2014, Ford recalled 692,700 Escape SUVs from the 2013-2014 model years because their doors didn’t latch properly.

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Source: http://indianexpress.com/article/business/companies/ford-recalls-570k-vehicles-for-fire-risk-door-latch-trouble-4591944/