Gujarat, Telangana halt sales of Roche's Avastin drug
New Delhi: Gujarat, Telangana have put sales of Swiss drugmaker Roche's blockbuster drug Avastin on hold, officials said, after it hampered the vision of 15 patients who used it for a condition it is not officially meant to treat.
Avastin is a cancer drug but is often used by doctors to treat vision loss even though it has not been approved by the US Food and Drug Administration for that purpose. Studies have shown that eye injections of Avastin curb vision loss.
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.
H.G. Koshia, the top drug controller in Gujarat, said he had directed distributors to recall one batch of the medicine given to the patients last week. Its samples were being tested following the incident at a hospital in Ahmedabad.
Following an alert from Gujarat, Telangana state has 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," Sai told Reuters. "We will release only if declared standard and safe for use."
Many doctors around the world use Avastin "off label" to treat 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".
"Roche will cooperate fully with any investigations undertaken by the authorities ... We are taking the events in Gujarat very seriously," the statement said.
Fifteen patients at C.H. 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.
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.
Avastin is a cancer drug but is often used by doctors to treat vision loss even though it has not been approved by the US Food and Drug Administration for that purpose. Studies have shown that eye injections of Avastin curb vision loss.
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.
H.G. Koshia, the top drug controller in Gujarat, said he had directed distributors to recall one batch of the medicine given to the patients last week. Its samples were being tested following the incident at a hospital in Ahmedabad.
Following an alert from Gujarat, Telangana state has 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," Sai told Reuters. "We will release only if declared standard and safe for use."
Many doctors around the world use Avastin "off label" to treat 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".
"Roche will cooperate fully with any investigations undertaken by the authorities ... We are taking the events in Gujarat very seriously," the statement said.
Fifteen patients at C.H. 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.
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.
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