Gujarat, Telangana have put sales of Swiss drugmaker Roche's blockbuster cancer drug Avastin on hold after its use for treatment of eye disease resulted in impairment of vision for 15 patients at an Ahmedabad hospital.
Avastin is a cancer drug but is often used by doctors to treat vision loss even though it has not been officially approved for it.
Studies have shown that eye injections of Avastin curb vision loss. However, the US Food and Drug Administration has also not approved the use of Avastin for treatment of eye problems. Nor did the company authorise its use for eye care.
Roche's India unit said the company does not promote the use of Avastin for treatments for which it is not approved, but has initiated an internal investigation after its use resulted in vision impairment for several patients.
Fifteen patients at CH Nagri Municipal Eye Hospital in Ahmedabad underwent surgery last week after they reported swelling and pain in their eyes after being administered Avastin. Six patients are still in the hospital. The hospital has administered the drug to 7,000 people over the last decade but has now stopped its usage, senior official Tejas Desai said.
Drug controller of Gujarat HG Koshia has directed distributors to recall one batch of the medicine given to the patients at the CH Nagri Municipal Eye Hospital in Ahmedabad last week. Its samples have also been sent for testing.
Following an alert from Gujarat, Telangana also ordered a freeze on all batches of Avastin being sold in the state, drug control official Surendranath Sai said. "We are stopping other batches also till the dust settles," Reuters quoted Sai as saying. "We will release only if declared standard and safe for use."
"Roche will cooperate fully with any investigations undertaken by the authorities ... We are taking the events in Gujarat very seriously," the statement said.
Avastin is used around the world for "off label" treatment of age-related macular degeneration, a leading cause of vision loss. Such usage, Roche said in statement, "bears the risk of contamination and has already led to serious bacterial infections of the eye in other countries around the world".
The hospital said all standard protocols were followed. Koshia, Gujarat's drug regulator, said they would need to ascertain whether the drug was a fake copy of Avastin.