Ministry of Health informs about injection that caused blindness in patient in Pakistan

Pakistan is investigating two distributors of the Swiss Roche cancer drug Avastin after 12 diabetic patients were blinded after receiving injections of the drug. Avastin is also licensed in Vietnam.

In Vietnam, as of September 27, the Drug Administration of Vietnam ( Ministry of Health ) has not received any reports reflecting unwanted side effects of Avastin related to patients losing vision after using Avastin.

The Drug Administration of Vietnam has received a report from the Representative Office of F. Hoffmann La Roche Ltd. about the incident.

Specifically, in Pakistan, about 12 patients lost their eyesight after using injections supplied by illegal supplier Genius Pharmaceutical Service. The drug was labeled "Inj. Avastin 1.25mg/0.05ml" causing the false perception that it was a Roche product.

Roche's Avastin is not approved for any ophthalmic use. Genius Pharmaceutical Service supplied/diluted/repackaged the 1.25 mg/0.5 ml dose under unsanitary and unapproved conditions.

Pakistani authorities are investigating the cause of the contamination. Possible causes include inadequate sterilization, contaminated vials, unsterilized syringes and deviations from standard operating procedures during dispensing.

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.

Event - Ministry of Health informs about injection that caused blindness in patient in Pakistan — (Illustration: 24 News HD).

In Vietnam, the drug Avastin (active ingredient Bevacizumab) has been granted 4 circulation registration certificates, all of which are still valid. Including:

Bevacizumab 100mg/4ml (box of 1 vial x 4ml; registration number: 400410250123 (QLSP-1118- 18); manufacturer: Roche Diagnostics GmbH, Germany).

Bevacizumab 400mg/16ml (box of 1 vial x 16ml: registration number: 400410250223 (QLSP-1119- 18); manufacturer: Roche Diagnostics GmbH, Germany).

Bevacizumab 100mg/4ml (box of 1 vial 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).

Avastin is licensed in Vietnam for the treatment of certain cancers, including metastatic colorectal cancer, advanced, metastatic, or recurrent non-small cell lung cancer, advanced and/or metastatic renal cell carcinoma, glioblastoma/malignant glioma (WHO stage IV); epithelial ovarian, fallopian tube, and primary peritoneal cancer.

In addition to the general warnings, the FDA-approved package insert includes a warning regarding "not for intravitreal use."

Specifically, the drug may cause visual disturbances, and individual cases and clusters of serious ocular adverse events have been reported following intravitreal injection, an unapproved route of administration with Avastin mixtures from vials intended for intravenous infusion in cancer patients.

These reactions include intraocular infection, endophthalmitis, uveitis, retinal detachment, retinal pigment epithelial tear, glaucoma, intraocular hemorrhage… Some of these events have resulted in varying degrees of visual field loss, including permanent blindness .

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