DCGI issues alert on ‘off-label’ use of Roche cancer drug in eye ailments

The Drug Controller General of India has issued an alert notice to State regulators on the use of multinational drugmaker Roche’s cancer drug Avastin in an off-label use to treat the eyes.

The drug has been used in the treatment of eye ailments and “this has lead to loss of vision” in certain patients at the Nagri Eye Hospital in Ahmedabad, the “alert notice” from the Indian drug regulator said.

“The drug is not approved in the country for intra-vitrieal use for ophthalmology purposes,” it added.

Responding to the development, Roche said that it did not promote the use of Avastin or any of its drugs in an indication for which it was not approved.

“Avastin® (Bevacizumab) has not been approved for intra-ocular use by the US FDA (US regulator), EMA (European regulator) or the Government of India,” Roche told BusinessLine .

“When prepared for off-label use in the eye, a single vial of the original Avastin product is partitioned/aliquoted in a hospital or pharmacy for use in multiple patients. This process bears the risk of contamination and has already led to serious bacterial infections of the eye in other countries. This information is also included in our updated prescribing information inserted in each pack,” it added.

Responding to concerns on whether the products may have been fake or counterfeits, Roche said, “We cannot say at this point in time. The safety of patients is very important to us. We are taking the events in Gujarat very seriously and have initiated an internal investigation.”

“We strongly recommend the use of Avastin is in line with the approved prescribing information,” it added.

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