Ministry of Health informs about cancer treatment drug that blinded 12 people in Pakistan

Earlier on September 25, the Drug Regulatory Authority of Pakistan (DRAP) said that the country's authorities were investigating two domestic distributors importing and trading the cancer treatment drug Avastin from Swiss company Roche, after 12 patients who received injections of the drug went blind.

Regarding this information, the Drug Administration of Vietnam said that on September 27, the Representative Office of F. Hoffmann La Roche Ltd. issued Official Dispatch No. RA/02/09/2023 reporting updated information on the investigation related to the above-mentioned drug Avastin.

Specifically, in Pakistan, about 12 patients lost their eyesight after using injections provided by illegal supplier Genius Pharmaceutical Service.

The medicine is labeled "Inj. Avastin 1.25mg/0.05ml" which could be misleading as being a Roche product. Roche's Avastin is not approved for any ophthalmic use.

Genius Pharmaceutical Service supplied/diluted/repackaged the drug at a dosage of 1.25mg/0.5ml under unsanitary and unapproved conditions.

Roche informed that the Pakistani authorities are currently investigating to determine the possible causes of the infection, including: Inadequate sterilization, contaminated vials, non-sterile syringes, and violations of standard operating procedures during the dispensing process.

At the same time, the Pakistani government has requested the recall of 3 batches of Avastin 100mg/ml (H352B11, B7266B07, B7266B20) of Roche and all drugs supplied by Genius Pharmaceutical Service.

The Drug Administration of Vietnam said that in Vietnam, Avastin still has 4 valid circulation registration certificates, specifically: Bevacizumab 100mg/4ml (box of 1 bottle x 4ml; registration number: 400410250123 (QLSP-1118-18); manufacturer: Roche Diagnostics GmbH, Germany); Bevacizumab 400mg/16ml (box of 1 bottle x 16ml: registration number: 400410250223 (QLSP-1119-18); manufacturer: Roche Diagnostics GmbH, Germany); Bevacizumab 100mg/4ml (box of 1 bottle x 16ml; registration number: QLSP-1010-17; manufacturer: F. Hoffmann-La Roche Ltd., Switzerland); Bevacizumab 400mg/16ml (box of 1 vial x 16ml; registration number: QLSP-1011-17; manufacturer: F. Hoffmann-La Roche Ltd., Switzerland).

Accordingly, Avastin is granted a circulation registration certificate in Vietnam with specific indications and warnings for the treatment of: metastatic colorectal cancer; advanced, metastatic or recurrent non-small cell lung cancer; advanced and/or metastatic renal cell carcinoma; glioblastoma/malignant glioma (stage IV - WHO); epithelial ovarian, fallopian tube and primary peritoneal cancer.

Avastin is warned against use for intravitreal injection. Reactions may include intraocular infection, endophthalmitis, conjunctival hemorrhage, and other serious adverse events. Some events have resulted in varying degrees of visual field loss, including permanent blindness.

The Drug Administration of Vietnam informed that, as of September 27, 2023, the Drug Administration of Vietnam has not received any reports reflecting the adverse effects of Avastin related to patients losing vision after using Avastin./.

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