Off Label Use of Roche’s Avastin in India Puts 15 in the Hospital, Prompts Officials to Halt Using the Drug

Off Label Use of Roche's Avastin in India Puts 15 in the Hospital, Prompts Officials to Halt Using the Drug
January 20, 2016
By Alex Keown, BioSpace.com Breaking News Staff

BASEL, Switzerland – Roche stock was slightly down this morning after reports that two Indian states put sales of cancer drug Avastin on hold after 15 patients experienced vision loss after taking the drug, Reuters reported this morning.

The patients took Avastin to treat a condition for which it has not been approved, Reuters said. Avastin is the blockbuster treatment for glioblastoma, a form of brain cancer, but some studies have shown that eye injections of Avastin can curb vision loss, which has prompted physicians to use the drug “off label” to treat problems such as macular degeneration. Roche manufactures Lucentis for the treatment of macular degeneration and has worked hard to get physicians around the world to not use Avastin for off-label treatments.

Roche's India unit told Reuters that the company does not promote the use of Avastin for treatments for which it is not approved, but has initiated an internal investigation. The company also said it is fully cooperating with Indian officials investigating the issue. According to reports, the 15 patients at C.H. Nagri Municipal Eye Hospital in Ahmedabad underwent surgery after they reported swelling and pain in their eyes after being administered Avastin. Six patients remain in the hospital, Reuters said.

Roche’s stock is down slightly this morning, trading at a low of $249.60 per share.

According to the Telengana, India-based Siasat Daily drug control officials said they were holding all samples of Avastin in the Indian states of Telengana and Gujarat. Officials have collected samples of the Avastin used on the patients for testing, according to reports.

India has seen its share of troubles with the administration of some medications, as well an abundance of counterfeit medications, in part due to an overburdened healthcare system, especially in smaller towns.

Reuters reported India has just 1,500 drug inspectors responsible for more than 10,000 factories, supplying medicines for a population of 1.2 billion and exporting to nearly 200 countries. There have been some issues of drugs manufactured in India from being marketed overseas due to manufacturing issues. In 2008, the U.S. Food and Drug Administration banned the sale of medicine from Indian drug maker Ranbaxy due to manufacturing violations. In March, the FDA issued a warning letter to Apotex over manufacturing violations at a plant in Bangalore, India. In its letter , the FDA said lab workers failed to ensure that laboratory records included complete data derived from all tests necessary to assure compliance with established specifications and standards. The FDA also said the lab workers failed to establish appropriate procedures to prevent bacteria from developing. Apotex was also forced to recall more than 65,000 bottles of blood pressure medication made at the Bangalore plant after testing discovered impurities in the medication.

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