An internal enquiry by the Swiss pharma giant Roche has revealed no quality problems with its anti-cancer drug Avastin, which resulted in vision loss in 15 patients in India. The drug was being used to treat eye problems without regulatory approval.
“In India, Roche has completed an assessment of the available information on the batch reported to have been used at C.H Nagri Eye Hospital in Ahmedabad, Gujarat. We can confirm that based on the information available, there is no reason to believe there were quality problems with the Avastin (Bevacizumab) vials in this batch,” a company spokesperson told swissinfo.ch.
In January, 15 patients in the western Indian state of Gujarat had to be admitted for surgery after complaining of eye swelling and pain after being administered the drug. Roche’s anti-cancer drug is widely used by ophthalmologists in India to treat eye diseases, despite lack of official approvals for this kind of use. This is known as off-label use.
Following the complaints, India’s Drugs Controller General issued a notice in January calling for a halt in the use of Avastin for eye conditions. However, the precautionary measure of halting off-label use of Avastin was later withdrawn in March, citing the drug’s proven efficacy and affordability.
Risk vs reward
In addition, two medical associations were mandated with the task of formulating guidelines for Avastin’s “safe and effective use” for eye diseases under “written informed consent” of the patient after an assessment carried out by “skilled ophthalmologic surgeons” based on “risk-benefit analyses”.
“We would like to reiterate that Avastin (Bevacizumab) has not been approved for use in the eye by the US FDA, EMA or the Government of India. Furthermore, it is not developed and manufactured to meet industry standards for intraocular injection solution,” said the Roche spokesperson.
The company representative also warned that Avastin was designed for single use in cancer cases and therefore does not contain any preservatives. He stated that using the drug in several doses for multiple patients augments the “risk of bacterial contamination and has already led to serious bacterial infections of the eye in other countries around the world”.
However, supporters of the off-label use of Avastin argue that Roche’s position stems from its desire to promote its drug Lucentis (Ranibizumab), which is legally approved for the same purposes. It is around 40 times more expensive than Avastin.