HQ Team
March 28, 2023: The WHO has issued a medical product alert on a contaminated cancer and autoimmune disease treatment drug made by Hyderabad, India-based Celon Laboratories, after Yemen and Lebanon raised concerns.
The medical product alert referred to a batch of “substandard” or contaminated Methotrex 50 mg identified in the two countries of WHO’s Eastern Mediterranean region, according to a statement.
The drug is on the WHO model list of essential medicines. Substandard medical products need to meet quality standards or WHO specifications.
Pediatric patients who were administered Methotrex or methotrexate experienced adverse events following microbiological testing on unopened medicine vials by health authorities of both nations.
Results in both countries were positive for pseudomonas aeruginosa, indicating contamination of the products, according to the statement.
Exclusive for India
Methotrexate was intended to be sold exclusively for the Indian market. The batch MTI2101BAQ available in Yemen and Lebanon, was procured outside the regulated supply chain.
“Therefore, the stated manufacturer cannot guarantee the safety of this product which was not destined for these markets.
However, informal markets may have distributed this product to other countries. It is crucial to detect and remove this contaminated product from circulation to prevent patient harm,” according to the WHO statement.
Celon Laboratories Pvt Ltd. confirmed to WHO that the batch number, manufacturing, and expiry date combination above matches their internal records. “At this stage, they have not had access to samples of the suspect products for their confirmatory testing.”
Officials of the Celon Laboratories were not immediately available for comment.
Methotrexate is a chemotherapy agent and immune system suppressant. Intrathecal, intramuscular, intravenous, or intra-arterial routes may give it.
Weaken immune system
Patients receiving methotrexate treatment may have weakened immune systems and be more vulnerable to opportunistic infections.
Pseudomonas aeruginosa bloodstream infection is a severe infection that may lead to death. Any product that has contamination and is administered directly to the body would present severe risks to patients.
Authorities were advised to notify the WHO if the product was discovered in their respective market. The global health agency urged manufacturers to test for microbial contamination before releasing finished product batches for use.
In January, the WHO issued medical product alerts on India’s Marion Biotech’s Ambronol and DOK-1 Max syrups as they failed to meet quality standards. Last October, it gave the same warning to the drugmaker Maiden Pharmaceuticals.
