Health authorities in Punjab, Pakistan, announced Monday the investigation into two distributors of the Swiss pharmaceutical company Roche, following incidents where 12 diabetic patients went blind after using the firm’s anti-cancer drug. The incidents might be caused by misuse of the drugs.
“Incidents of loss of vision in diabetic patients have been reported following treatment with … Avastin injection,” regulators said in a press statement.
Avastin, clinically known as bevacizumab, is licensed for use in Pakistan and was first approved by the U.S. Food and Drug Administration (FDA) in 2004 to treat advanced colon cancer. It has since been given the go-ahead as a therapeutic for advanced lung, kidney, and brain cancers. The Drug Regulatory Authority of Pakistan (DRAP) also green-lit the drug to treat colorectal and other metastatic carcinomas.
The FDA allows off-label use of Avastin, but only if doctors are knowledgeable about the product and the evidence supports that the drug will be beneficial in such a situation. One of these situations is treating eye diseases like diabetic retinopathy.
However, Avastin is not approved as a therapeutic for diabetic retinopathy by the DRAP.
“The use in diabetic retinopathy is an off-label use to block the growth of abnormal blood vessels in the eye,” DRAP officials said in the same statement. “Since this drug was being dispensed/diluted/repacked … under unhygienic conditions and in an unapproved manner, therefore, its safety cannot be ascertained which may lead to damage and loss of vision in the patients.”
According to Reuters, Javed Akram, the province’s Minister for Specialized Health, said police were questioning two men believed to be the drug’s distributors in the state. The DRAP demanded a recall of the suspected 100-milligram botched injection batches, thought to have been created illegally.
“In Pakistan, the vision loss from Avastin has been identified by the authorities as a case of contamination by a third party supplier,” Roche told Reuters in a press statement. “The sale/distribution of registered Avastin injection has been put on halt till verification of its quality through sampling and laboratory testing to safeguard public health,” according to the DRAP website.
The health authority says health care professionals are directed to cease distributing, dispensing, and administering Avistan immediately. Any remaining product stock should be quarantined and returned to the supplier.
Recommendations for the Public
In the meantime, health authorities say patients should not use Avastin for eye diseases under any circumstances and should contact their primary health care provider if they experience any problems related to taking it. Adverse reactions should be reported to DRAP’s National Pharmacovigilance Centre.
“All therapeutic goods must be obtained from licensed pharmacies and other authorized/licensed retail outlets,” DRAP said. “The authenticity and condition of products should be carefully checked. Seek advice from your pharmacists or other healthcare professionals in case of any doubt.”