Contaminated cancer drug batch identified in Lebanon, Yemen

A batch of a contaminated drug for the treatment of cancer and autoimmune diseases has been identified in Lebanon and Yemen, the World Health Organization has warned.

The WHO said the alert refers to “one batch of substandard (contaminated) METHOTREXTM (methotrexate) 50mg.”

“Following adverse events in pediatric patients receiving METHOTREXTM 50mg, the health authorities in both Yemen and Lebanon conducted microbiological testing on the remaining unopened vials of METHOTREXTM 50mg. Results in both countries were positive for Pseudomonas aeruginosa, indicating contamination of the products,” the WHO added.

The stated manufacturer, CELON Laboratories Pvt Ltd., confirmed to WHO that the batch number, manufacturing, and expiry dates combination match their internal records. At this stage, the manufacturer has not had access to samples of the suspect products for its own confirmatory testing.

Methotrexate is a chemotherapy agent and immune system suppressant. It may be given by intrathecal, intramuscular, intravenous, or intra-arterial routes. Patients receiving methotrexate treatment may have weakened immune systems and be more vulnerable to opportunistic infections.

Pseudomonas aeruginosa bloodstream infection is a serious infection that may lead to death and any product that has any contamination and is administered directly in the body would present serious risks to patients.

The WHO noted that METHOTREXTM 50mg batch MTI2101BAQ was intended to be “sold exclusively on the Indian market,” noting that the batch 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,” the WHO added.

“However, it is likely that this product may have been distributed to other countries through informal markets. It is important to detect and remove this contaminated product from circulation to prevent harm to patients,” it warned.

The WHO also urged increased surveillance and diligence within the supply chains of countries and regions likely to be affected by this product, adding that increased surveillance of the informal/unregulated market is also advised.

“Competent authorities are advised to immediately notify the WHO if this product is discovered in their respective market,” it said.

In remarks to MTV, the head of the Order of Pharmacists of Lebanon, Joe Salloum, said the drug had been “smuggled” into Lebanon and that it is present in some hospitals and not in pharmacies.