Dr. Javed Ikram, Punjab’s interim health minister, revealed that a drug associated with vision loss in numerous patients was administered without proper authorization and informed consent.
Dr. Ikram held a press conference in Lahore and explained that Avastin, a drug usually used for cancer treatments, especially for liver and kidney conditions, is administered intravenously. He further revealed that nearly 68 patients used the drug for eye treatments.
Dr. Ikram pointed out that injecting this drug into the eyes constitutes an off-label use, which has not received approval from the Drug Regulatory Authority of Pakistan or the relevant drug authorities in the United States or India. While off-label use is not uncommon, it usually requires prior permission from the Drug Regulatory Authority of Pakistan. In this case, the authorities did not get permission from the authority.
Additionally, Dr. Ikram emphasized that good clinical practices include obtaining “informed consent” from patients, ideally in their local languages. Unfortunately, those responsible did not give the affected patients the opportunity to provide informed consent.
Initially, the government imposed a complete ban on the use of the drug, but it has since allowed its intravenous use for cancer patients. Dr. Ikram mentioned that they are currently analyzing the two questioned batches, 3218 and 3239, and if they detect any contamination, they will destroy them.
Furthermore, the government has decided to mandate informed consent for the drug’s usage. Dr. Ikram explained that they must record this consent on video rather than just in writing.
Injection Causing Vision Loss Removed From Market, Legal Actions Initiated: Health Minister
Earlier, Caretaker Federal Health Minister Dr. Nadeem Jan announced the removal of a domestically-produced injection from the market, which resulted in vision loss among multiple patients in Punjab.
Dr. Nadeem Jan made the announcement at a press conference alongside Punjab Health Minister Dr. Jamal Nasir in Islamabad. He stated that they recalled the injection stock from circulation and took stringent measures against two drug suppliers. Reports of vision impairment resulting from the injection came from various regions, including Multan, Kasur, Faisalabad, and Sadiqabad. The minister emphasized that they are conducting a comprehensive investigation and assured that the affected patients would receive the best possible healthcare.
Punjab Minister for Primary and Secondary Healthcare, Dr. Jamal Nasir, revealed that the injection in question is a 100mg dose, and approximately 14 to 20 patients suffered vision loss. He added that relevant authorities initiated legal action against Naveed and Bilal for producing a substandard drug with exorbitant prices. Dr. Nasir also pointed out that retailers were making significant profits from the injection. The Drug Regulatory Authority of Pakistan (DRAP) has withdrawn the entire batch from the market, and retailers will not sell it until the investigation concludes.
The Punjab government has established a five-member committee to investigate eye injuries caused by the Avastin injection. Dr. Asad Aslam Khan from King Edward Medical University leads the committee, which will submit its findings within three days and offer recommendations to prevent such incidents in the future. Other committee members include Director General Drugs Control Muhammad Sohail, Dr. Muhammad Moin from Mayo Hospital, Dr. Tayyaba from Lahore General Hospital, and Prof. Dr. Mohsin from Services Hospital.
