The Drug Administration of Vietnam (DAV) under the Ministry of Health on Wednesday said it has not received any reports indicating adverse effects of Swiss pharmaceutical company Roche’s Avastin cancer drug, a treatment associated with 12 Pakistani patients losing their vision.
The DAV affirmed that Avastin’s four previously-granted registration certificates for circulation within Vietnam remain active.
The agency made the announcement following the Roche representative office in Vietnam’s update on the ongoing investigation into the use of the drug Avastin in Pakistan.
The probe was carried out after 12 diabetic patients in Pakistan who were injected with a drug labeled 'Inj. Avastin 1.25mg/0.05ml' went blind.
The drug was distributed by unauthorized provider Genius Pharmaceutical Service, but its label led to the misunderstanding that it was an authentic product produced by Roche.
In fact, Genius Pharmaceutical Service 'altered/dispensed/diluted' Roche’s original Avastin 100mg/ml into a dosage of 1.25mg/0.5ml in unsanitary and unapproved conditions.
According to Roche, Pakistani authorities are conducting an inquiry to ascertain potential factors behind the infection.
This investigation is looking into allegations of inadequate sterilization, vial contamination, unsterilized syringes, and deviations from standard practices during the drug dispensing procedure.
Simultaneously, Pakistani authorities have requested a recall of three specific lots of Avastin 100mg/ml from Roche, along with all medications provided by Genius Pharmaceutical Service.
On its website, Roche said Avastin was approved in more than 130 countries, including the United States, to treat several types of cancer.
“Roche strongly condemns this criminal act of counterfeiting and is doing everything in its power to cooperate with the authorities to protect patients from counterfeits,” said Roche in a statement to Reuters.
“In Pakistan, the vision loss from Avastin has been identified by the authorities as a case of contamination by a third party supplier."
The Drug Regulatory Authority of Pakistan said in its statement that Avastin has also been used off-label to treat diabetes-related eye conditions.
Avastin, when used at much lower doses, is similar to eye drug Lucentis and is used in many countries as a low-cost option to treat certain vision-loss conditions.
“Avastin is not approved for any use in the eye. Counterfeit medicines pose a health risk to patients because their content may be ineffective and contain harmful ingredients,” Roche said in its statement.
According to Reuters, some companies in Pakistan buy Avastin and repackage it in smaller doses to make it more affordable for patients.
In Vietnam, the drug Avastin is legally available in two variants -- one with a concentration of 100mg/4ml and another with 400mg/16ml.