According to the Drug Administration of Vietnam (Ministry of Health), today, 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 drug Avastin.
Previously, the department received information from authorities in Pakistan announcing a temporary ban on the use of a cancer treatment drug distributed by the Swiss pharmaceutical company Roche for investigation, because 12 patients went blind after being injected with the drug.
In Vietnam, Avastin has been granted 4 valid circulation registration certificates.
According to the Drug Administration of Vietnam, in Vietnam, Avastin, a drug used to treat certain cancers, has four valid registration certificates. This drug is granted a registration certificate with specific indications and warnings.
In particular, the drug is indicated for patients with metastatic colorectal cancer; advanced, metastatic or recurrent non-small cell lung cancer; advanced and/or metastatic renal cell carcinoma; glioblastoma, malignant glioma (stage 4); 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."
The drug may cause visual disturbances. Individual cases and clusters of serious ocular adverse events have been reported following intravitreal administration of Avastin from vials intended for intravenous use in cancer patients, which is an unacceptable route of administration due to the potential for the following reactions: Intraocular infection, endophthalmitis such as sterile endophthalmitis, uveitis and vitritis, retinal banding, retinal pigment epithelial tear, increased intraocular pressure, intraocular haemorrhage such as vitreous haemorrhage or retinal haemorrhage and conjunctival haemorrhage. Some of these events have resulted in varying degrees of vision loss, including permanent blindness.
A representative of the Drug Administration of Vietnam said that in Vietnam, this agency has not yet received any reports reflecting unwanted effects of Avastin related to patients losing vision after using Avastin.
According to a report by the representative office of F. Hoffmann La Roche Ltd., updated information on the investigation related to Avastin in Pakistan, about 12 patients lost their vision after using injections supplied by illegal supplier Genius Pharmaceutical Service. The drug was labeled "Inj. Avastin 1.25 mg/0.05 ml" causing the false perception that it was a Roche product.
Roche's Avastin is not approved for use in any ophthalmic indication. Genius Pharmaceutical Service supplied, diluted, and repackaged the 1.25 mg/0.5 mL dose under unsanitary and unapproved conditions.
Pakistani authorities are investigating possible causes of the contamination, including inadequate sterilization, contaminated vials, unsterilized syringes, and violations of standard operating procedures during drug dispensing.
Source link
Comment (0)