ISLAMABAD: Punjab’s interim health minister Dr. Javed Akram announced on Tuesday an experimental medication suspected of causing vision loss among dozens of diabetics across the province was administered by hospitals without seeking prior approval from the Drug Regulatory Authority of Pakistan (DRAP).
Nearly 70 patients from various districts in Punjab reported eye infections leading to blindness in recent weeks after receiving doses of injectable medicine called Avastin. The medication is primarily used to treat cancer but is also prescribed off-label in Pakistan for diabetic retinopathy-related edema.
Pakistan imposed a temporary ban on the drug earlier this week and initiated an inquiry to assign responsibility after patients began losing their vision.
“The ocular use of this medicine has not been approved by anyone,” said the provincial health minister. “It has not been approved by the [US] FDA [Food and Drug Administration], DRAP, Indian authorities or claimed by [the manufacturer] Roche itself.”
“This was an off-label use,” he continued. “It is mandatory in such cases to seek permission from DRAP ... which did not happen. Moreover, the good clinical practice of securing informed consent [from patients in such cases] was also not followed.”
Dr. Akram emphasized that it was necessary to seek a patient’s consent “in the local language when administering an experimental drug.”
He disclosed that the government had now decided to require audiovisual recordings from hospital authorities, demonstrating that patients had been clearly informed of the benefits and risks associated with off-label medication use.
The minister reiterated the government’s commitment to bringing those responsible for this criminal negligence to justice and confirmed that Avastin would be available only for cancer treatment while the inquiry continued.