Drug Regulatory Authority of Pakistan (DRAP) has put the use, sale and distribution of registered Avastin Injection on halt till verification of its quality and safety.
DRAP has also directed Roche Pharma, importer of Avastin Injection, to recall stock of suspected batches from the market immediately to safeguard the public health.
Samples of registered Avastin injection have been sent to Drug Testing Laboratory for analysis for verification of quality and safety of this product.
The healthcare professionals, pharmacists and chemists have been directed to stop the distribution, dispensing and administration of this product immediately and check their stocks and stop supplying this product.
The remaining stocks should be quarantined and returned to the supplier/company.
The development came after dozens of people were hospitalized for developing serious eye infections and many losing vision following the administration of Injection Avastin.
After reporting of cases of diabetic patients losing vision , the regulatory field force raided the premises of M/s Genius Advanced Pharmaceutical Services, Lahore, involved in the repacking and dispensing of Avastin injection under unhygienic/non-sterile conditions.
As per the DRAP, Avastin injection is registered to treat colorectal and other metastatic carcinomas.
The use of this drug in diabetic retinopathy or other ophthalmic conditions is one of the off-label uses and not approved by DRAP.
The incident is linked with the alteration/dispensing/dilution and sale of Avastin 100mg/4mL Injection under unhygienic/non-sterile conditions illegally and without any Drug Sale/Dispensing License (DSL) from Provincial Health Authority by M/s Genius Advanced Pharmaceutical Services Lahore.
Since, this drug was being dispensed/diluted/repacked in 1.25mg/0.05ml dose under unhygienic conditions and in an un-approved manner, therefore, its safety cannot be ascertained, which may lead to damage and loss of vision in the patients.
DRAP requests increased vigilance at hospitals and within the supply chains of institutions/pharmacies/healthcare facilities regarding the off-label use of this product.
Adverse reactions or quality problems experienced with the use of this product shall be reported to the National Pharmacovigilance Centre(NPC), DRAP using Adverse Event Reporting Form or online.
DRAP advised patients to not use this product for any ophthalmic disease and should contact their physician or healthcare provider if they have experienced any problem related to taking or using this drug product.
Committee formed to probe serious eye infection cases due to Inj Avastin
